Tailored specifically to emerging biotech companies, Vault Basics delivers a pre-configured, pre-validated suite of applications, including Vault eTMF Basics, Quality Docs, Training Basics, Submissions, and Submissions Archive Basics, that support critical GxP functions from day one.  Powered by the Veeva Vault Platform, this cloud-native solution enables biotechs to centralize content and data, streamline processes, accelerate compliance, increase productivity, and more. Below, we outline five considerations for companies when evaluating Veeva Vault Basics as a foundational system:  

Vault Basics for Biotech Companies  

1. Cost Efficiency: Vault Basics is a pre-configured, pre-validated solution, which significantly reduces implementation and maintenance costs for biotech companies. This “ready-to-use” approach enables biotechs to see a faster return on investment while also improving compliance and operational efficiency. By streamlining processes and reducing manual work, biotechs can redirect internal resources to high-value scientific and clinical priorities, ultimately increasing their teams’ productivity and saving costs in the long term.
2. Built-in Flexibility: Staying competitive means recognizing and focusing on your core strengths as an organization but remaining adaptable and agile to scale as needs evolve. Veeva Vault Basics enables biotechs to focus on innovation, not infrastructure, by delivering flexible functionality across clinical, quality, and regulatory domains. With out-of-the-box workflows that can evolve as the company grows, Veeva Vault Basics allows teams to avoid unnecessary customization and spend value-add time on staying responsive and agile. 
3. Seamless Collaboration: Biotechs can leverage Vault Basic’s suite of applications to facilitate efficient collaboration across different departments and geographies. Features such as real-time document editing, version control, and role-based access permissions ensure that teams (from clinical to regulatory to quality) can work in sync. Whether it’s submitting regulatory or clinical trial documentation or managing SOPs, Vault Basics facilitates and accelerates cross-functional workflows.  
4. Scalable Foundation for Adaptive Growth: Designed with emerging biotechs in mind, Vault Basics provides a strong digital foundation that scales with the organization. Its intuitive user interface and GxP-ready architecture help keep teams aligned with both industry standards and evolving regulatory expectations. Via one shared platform across functions, biotech teams are equipped to scale operations without outgrowing their systems.  
5. Protecting Intellectual Property for Competitive Advantage: Vault Basics is built on the trusted Veeva Vault Platform, providing a secure, compliant foundation specifically designed for the life sciences. With enterprise-grade security, robust audit trails, and role-based access controls, for example, it safeguards critical intellectual property across all GxP functions. Fully aligned with regulatory standards such as 21 CFR Part 11 and EU Annex 11, Vault Basics includes modules like Quality Docs, Submissions, and Training Basics to embed compliance from the start, mitigating risk while enabling long-term growth and competitive advantage. 

Deciding on Veeva Vault Basics  

Vault Basics replaces fragmented, siloed systems with a unified platform that automates workflows, reduces manual errors, and supports smarter decision-making through integrated dashboards and reporting. Its seamless integration capabilities ensure data consistency and enable enterprise-wide collaboration. 

More than just a technology solution, Vault Basics offers a strategic foundation for biotechs navigating resource constraints. By embracing its streamlined approach to operations, organizations can do more with less, maximizing efficiency and building the resilience needed to succeed both today and in the future. As with any technology investment, it’s essential to assess whether Vault Basics aligns with your organization’s specific needs. Wherever you are on your Veeva journey, our team can support. Reach out to us today.   

Contributions by Anjali Chhamunya and Shanaya Tate

The post Exploring Veeva Vault Basics for Biotech Companies   appeared first on Clarkston Consulting.

Download the Implementing a Global Veeva Vault QMS Case Study Here

Clarkston recently partnered with a leading biopharmaceutical company to support a multi-year Veeva Quality Management System (QMS) implementation. After several recent acquisitions, the client had been using both Trackwise and Agile for their quality management systems globally. The client faced many challenges due to these disparate systems and often struggled with potential upgrades, such as improving functionality, information connectivity, process automation, and external collaboration. 

The client engaged Clarkston to help implement a unified QMS, including the full replacement of legacy quality systems. This three-year Veeva Vault QMS implementation streamlined their systems and impacted thousands of users across over a dozen offices globally. 

Clarkston successfully guided the client toward embracing the next generation of quality management systems, positioning them to grow and lead in delivering cancer treatments worldwide. Clarkston worked in close partnership with the client’s business and technical stakeholders, as well as directly with Veeva, over three years to achieve global harmonization of the quality systems into a single Quality Ecosystem that is scalable and compliant. The system implementation was conducted in three phases, each addressing on-site requirements, the previous system, business processes, digital data volume and complexity, user experience, and scalability. 

Clarkston collaborated with over 300 users to understand the business’s and employees’ needs, optimizing manufacturing processes and scaling them after the merger. The focus was on building modules tailored to the client’s requirements. Designed with best practices and automated workflows, Veeva’s QMS unites all sites and elevates the organization’s quality processes, improving business control and visibility. 

Clarkston helped the client embrace the next generation of quality management systems, enabling them to lead in this space for years to come.​ 

Download the Implementing a Global Veeva Vault QMS case study, and learn more about our Veeva Consulting Services by contacting us below. 

Contact Us to Learn More

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3 Strategies for Data-Driven Change Management for Retailers

1. The Role of Change Agents in a Data-Driven Project 

A change agent guides a team through the adoption of new tools, especially complex data technologies. Typically a team leader, they help users understand the tool’s benefits, reduce resistance, and ease the learning curve. With an analytical mindset, they adapt to evolving data needs, use insights to drive successful adoption, ensure smoother transitions, and enhance both workflow and overall performance.

2. The Agile Methodology Framework Complementing Data Projects 

Agile methodology embraces and manages change. It allows for shifting priorities based on real-time data during a project, which is useful for retail teams to respond quickly to evolving business needs rather than being locked into a rigid plan. Agile ensures data projects stay aligned with business outcomes by focusing on purpose and flexibility.

3. Retailers Leveraging AI and Automation for Data-Driven Insights 

AI and automation are key for effective change management in data adoption. AI tools track user progress, identify challenges, and provide real-time insights, helping retailers allocate resources where needed. AI can flag areas where users struggle and predict potential resistance through feedback and usage data. This data-driven approach ensures smoother adoption and maximizes the benefits of new tools.

The data-driven era presents retailers with powerful opportunities to boost efficiency and fuel business growth. However, realizing these benefits depends on effective change management that addresses both technical and cultural challenges. By empowering analytical change agents, embracing Agile methodologies, and using AI-driven insights to inform decisions, retailers can lay the groundwork for successful adoption of new data technologies. Keep reading by downloading the eBook below.

Download the Data-Driven Change Management for Retailers eBook

The post Strategies to Enable Data-Driven Change Management for Retailers appeared first on Clarkston Consulting.

The FDA announced on May 8, 2025, that the agency will implement artificial intelligence to all FDA centers by the end of June 2025. This decision is following a recently completed pilot program to use generative AI to assist in scientific reviews, which demonstrated the ability to drastically reduce the time required to complete tedious and repetitive tasks. 

Though business leaders within the life sciences industry have taken the opportunity to understand the landscape of AI, including infrastructure and use cases, some are hesitant to fully adopt this new platform due to compliance concerns and to adhere to regulatory standards.  

Now that the regulatory authority is embracing this novel technology, it’s time for companies to fully consider the potential benefits of these solutions while creating a roadmap to ensure holistic training data and validation. Just as the FDA is exploring ways to best use artificial intelligence, there is a breadth of opportunities for pharmaceutical companies to consider. In this piece, we unpack opportunities for AI in drug product development.

Use Cases for AI in Drug  Product Development 

The expansion of AI has developed anticipation due to its enablement of complex analytical techniques, such as the ability to use AI in drug development by screening chemical compounds. These novel applications have a real potential to create breakthroughs in the pharmaceutical development process, but require a strong data foundation to achieve success. To achieve these long-term strategic goals, consider starting with early use cases of AI while continuously developing your AI infrastructure, building from a crawl to a walk, then to a run. 

Crawl 

A starting point, or a crawl, when using generative AI should include a repetitive process with the potential to save valuable time. For example, a chatbot could be used to quickly educate the sales force team about the products and disease indication. This ChatGPT-like model could summarize marketing material or scientific articles in a way that is digestible and easy to understand. This would require a model that can integrate into a company’s document-sharing platform to connect directly to scientific and marketing documentation. This will be especially important if the FDA shortens time from BLA submission to approval by using the enhanced scientific review. 

Walk 

As an organization grows in their data and analytics capabilities, the group can transition to more complex use cases, a walk, including quickly analyzing large datasets. For example, an LLM could be connected to clinical trial datasets and automatically determine product efficacy on a study cohort. This more sophisticated application will require increased investment in data engineers to harmonize clinical data, data scientists to develop analytical tools, and technology platforms to store data. In addition to the technology, it’s necessary to increase investments to validate the tool and train users to know when to trust the output and when additional verification is required. 

Run 

Following the implementation of these initial use cases, leaders can prepare for greater investment to apply intelligence to all areas of the drug development process, leading to a run. By leveraging models that can identify target disease pathways or predict drug candidates, companies can accelerate preclinical discovery, leading to a breakthrough of product approval. These models could utilize clinical and preclinical data to understand biological mechanisms and molecules of interest, while also developing tool governance and risk mitigation. 

Both the FDA and pharmaceutical companies can shorten the time to market by leveraging AI, leading to faster scientific innovation and better patient care. Insilico has become a leader in this space by using AI to optimize their drug discovery program, requiring only a fraction of the time and money to develop their preclinical idiopathic pulmonary fibrosis product. As this new drug development method gains popularity, it is necessary to consider these novel research methods to remain competitive. 

Thinking Through Your AI Strategy  

With all tool implementations, organizations must consider people and processes in addition to the technology itself. Depending on the use case, these tools might require GxP compliance, necessitating additional validation efforts. Proper governance of the tool may need to be established to standardize tool and data access, protecting preclinical and clinical data. 

To prepare for this institutional investment, an implementation roadmap may be necessary to best consider compliance, governance, and training data. Contact Clarkston’s data strategy experts to begin understanding your artificial intelligence strategy. 

The post Opportunities for AI in Drug Product Development appeared first on Clarkston Consulting.

Key Challenges in Retail Warehouse Migrations  

1. Disruptions and Downtime Costs 
A significant challenge during warehouse migrations is the potential for disruptions and downtime, which can be extremely costly. Downtime during a warehouse migration can result in losses ranging from $10,000 to $100,000 per day depending on the scope of the migration. Based on what we have seen in industry, these costs stem from things like shipment delays or inventory management errors. Minimizing downtime is essential to maintain business continuity and control operational costs.  

2. Inventory Management and Traceability 
Managing inventory effectively during a warehouse migration is another critical challenge. When relocating large quantities of goods, discrepancies in inventory records can occur, leading to inefficiencies or errors that can have long-term consequences. Retailers often face inventory management challenges during relocations, especially when manual tracking methods are used. Modernizing the way systems communicate, like upgrading the integration layer between Warehouse Management Systems (WMS) and the ERP, can help ensure accuracy and traceability during transitions. According to a 2024 Warehouse Efficiency Report, 45% of businesses that migrated warehouses reported inventory management as one of their top three challenges.   

3. Change Management and Communication 
Poor communication with internal teams and external stakeholders can create confusion during migrations. With so many parties involved in a retail warehouse migration (project teams, warehouse staff, suppliers, logistics providers, customers, etc.), effective communication can be very difficult. For example, a failure to coordinate with the compliance team on proper ticketing, labeling, and palletization procedures can lead to increased B2B customer chargebacks when shipping out of the new warehouse. When communication breaks down, project timelines are pushed back, and inventory becomes harder to manage. As a result, customers may lose trust and become dissatisfied.  

Strategies for Successful Retail Warehouse Migrations  

While the challenges above can be difficult, the strategies below can help retailers navigate them successfully.  

1. Thorough Planning and Phased Implementation 
Successful warehouse migrations require careful planning and organization. A popular strategy is breaking the migration process into smaller, manageable phases by de-coupling inbound and outbound inventory flows, allowing businesses to better control each aspect of the move—from inventory transfer to employee training and systems integration. Phased implementation also allows businesses to maintain operations at reduced capacity, minimizing risk and allowing for adjustments as needed.  

Clarkston takes this approach to help mitigate operational disruptions and ensure that each step is thoroughly executed before progressing. Leveraging forecasts and data from previous years’ sales is another strategy to increase a plan’s efficacy. This helps facets of the migration process, like determining the best time of year to migrate and identifying what products and channels need to be migrated.   

2. Building Redundancy and Risk Mitigation Plans 
Building redundancy is a critical strategy for managing the risks associated with warehouse migration. This may include temporary storage facilities, backup systems for inventory management, or additional personnel to ensure key processes continue without interruption. Retailers with ship-from-store capabilities could add backstock in stores to make the warehouse less critical in the short run. Based on our past successful warehouse migrations, we have seen that redundant processes help avoid bottlenecks and ensure operations remain functional, even when faced with unexpected delays.  

3. Clear and Consistent Communication 
Clear and consistent communication with internal and external teams is key to a smooth warehouse migration. Companies that prioritize communication not only see a reduction in employee turnover during migration, as staff members are better informed and more confident in the process but are also 33% more likely to meet original project goals, 43% more likely to stay within budget, and 58% more likely to complete projects on time. Additionally, effective communication reduces scope creep by 34% and decreases the chance of project failure by 35%.   

From a migration project perspective, effective communication means alerting internal teams pertinent to the project early in the process, consistent project timeline updates with key stakeholders and project teams, and cross-functional collaboration. Standing calls between operations, IT, and others crucial to project success are a great way to facilitate this.  

For retailers, this means communication between production operations and warehouse teams, or coordination between inbound and outbound logistics teams to optimize inventory flow, enhance the supplier and carrier relationship, and reduce costs. For example, Cart.com helped a company boost order efficiency by 60% as a result of a strategic partnership. Lastly, we suggest businesses notify customers in advance of potential disruptions, such as delays in deliveries or changes in return policies, to manage expectations and maintain customer satisfaction.   

4. Establishing Escalation Protocols 
Predefined escalation protocols are essential for addressing issues that arise during a warehouse migration. Critical problems, such as system failures or shipment delays, can quickly derail a migration. Establishing a clear chain of command and ensuring that all teams know who to contact in the event of an issue is a common practice that greatly reduces the blowout from issues that arise. This is achievable by setting up standing hypercare calls or having rapid resolution emergency bridges. Practicing this helps businesses resolve problems quickly and keep the warehouse migration project on track. At the bottom line, businesses with well-defined escalation protocols are better equipped to meet migration timelines.  

Final Thoughts  

Warehouse migrations present various challenges, including managing inventory, minimizing downtime, navigating change management, and maintaining customer satisfaction. However, with the right preparation and strategy in place, retailers can overcome these obstacles.  

Reach out to learn more about our retail supply chain strategy consulting.  

Contributions by Sahab Grover and David Mathai

The post Navigating Retail Warehouse Migrations: Challenges and Strategies appeared first on Clarkston Consulting.

Standard Operating Procedures (SOPs) and Work Instructions (WIs) are similar documents businesses use to support safety and understanding of how work procedures should be completed. While they serve similar purposes, there are important distinctions between the two. SOPs provide a broad overview of how to complete processes, while WIs are detailed step-by-step guidelines that explain how to perform specific tasks to ensure clear and actionable execution. Since WIs are clearer, they help reduce the risk of errors and improve training and quality.  

The Importance of Clear and Actionable Work Instructions (WIs) 

Clear and actionable WIs are crucial for ensuring safety, efficiency, consistency, and improved productivity. Without clear work instructions, employees might interpret tasks differently, leading to inconsistencies in quality, safety risks, and delays. To avoid this, companies are using software solutions, such as Veeva Quality Docs.  

What is Veeva and How Can it Help? 

Veeva is a cloud-based management platform that provides solutions across a wide span of industries, largely focusing on life sciences. Some of these solutions include data management during clinical trials, commercial operations to help manage customer relationships, and quality management to help manage quality processes. Additionally, Veeva offers an electronic document management system (eDMS) for items such as WIs. Utilizing Veeva can significantly streamline the process of writing WIs by proving a structured, compliant, and collaborative environment for document creation and management. Some if its key components include: 

1. Standardized Templates  

Veeva allows users to load their current templates into the platform to be used for WIs. Standardizing ensures consistency in both formatting and content structure.  

2. Version Control and Audit Trails 

Veeva utilizes version control, which tracks every change that is made to a WI to ensure there’s a clear history of edits, reviews, and approvals where applicable to the workflow. Veeva is also equipped with an audit trail functionality to provide a transparent record of who made what changes and when they made them. 

3. Collaborative Review Workflow 

Automated workflows help to route WIs for review and approval to ensure they go through the correct quality and compliance checks. Users can also collaboratively work on a single document in real time, helping to reduce time spent reviewing and editing.  

4. Compliance and Regulatory Alignment 

Veeva has electronic signatures enabled, which ensures regulatory compliance with FDA 21 CFR Part 11. 

5. Easy Distribution and Searchability 

Once approved, WIs can easily be published and made accessible to employees. WIs can also easily be searched and retrieved by using tags, roles, tasks, and keywords to help reduce time spent looking for the correct document. 

While Veeva helps to streamline work instruction management, it’s still essential to ensure clarity and effectiveness in the writing process, too.

How to Write Clear Work Instructions in Veeva 

Implementing work instructions requires several key steps to ensure they are clear and actionable. Below are the steps that should be followed when creating WIs in Veeva. 

1. Access the Work Instruction Template 

The first step to developing clear and actionable WIs is to access the work instruction template if it’s available. Using a standardized work instruction template ensures consistency for all instructions. If a template isn’t available, you may create a new document using your organization’s established structure to support consistency.  

2. Define the Purpose and Scope 

The next step is to define the purpose and scope of the work instruction. This includes stating the goal of the task and identifying its intended users with their responsibilities. It’s also important to mention any governing procedure and documents, materials, or training needed to complete the work instructions effectively. 

3. Write Step-by-Step Instructions 

Next in the process is writing the step-by-step instructions. These steps are written under the “Procedure” section of the template. When writing the work instructions, it’s important to use clear, concise, and actionable language that will guide the user through each task to avoid uncertainty. Each step should be written in sequential order using specific actionable verbs such as “Click,” “Next,” or “Finally” to prompt the action. Additionally, avoid using vague terms such as “handle appropriately” or “as needed,” as this can lead to unsureness.  

Additionally, each step should focus on a single action at a time to prevent confusion or misinterpretation. Rather than combining multiple sentences, such as, “Click the blue ‘Create’ button then click ‘Document,’” break it into two separate steps. If a written step seems confusing, adding visual aids, such as annotated screenshots, can be used to help avoid unnecessary confusion. In addition, creating warnings, tips, or reminders beneath perplexing steps can also reduce uncertainty. 

Consistent formatting is also imperative. Use numbered lists for steps as well as consistent font, spacing, and headings throughout the work instructions to make it easier to follow. Below is an example of how good formatting should look for a work instruction.  

1. Procedure
  1.1 Writing a Work Instruction
     1.1.1 Define the Purpose
       1.1.1.1 The purpose of a work instruction should clearly define why the instruction exists and what it aims to achieve. 

You’ll also want to test the work instructions to ensure that the steps are accurate and easy to understand. 

4. Route for Review and Approval 

Once the work instruction is drafted, it should be routed for review and approval. During the review phase, document owners can track the review progress by seeing who has or hasn’t completed their assigned review tasks. They’re also able to respond to annotations, recall the document from the review process if there are changes that need to be made, and cancel the workflow if needed.  

Reviewers are granted different capabilities than document owners. Reviewers with read-only access are only able to view the document, while those with full access can add annotations, such as comments or suggestions, and can also view other annotations. Direct edits aren’t permitted during review; annotations must be used to suggest changes. Users with full access are also granted the ability to complete the “review document” task. Although all annotations in the document don’t need to be addressed before sending the document for approval, it is best practice.  

After all reviewers have completed their tasks, the document can now be put into the approval phase. In approval, individuals assigned the approval task can view and leave annotations just as the reviewers. Approvers are also able to approve or reject the document. Once all approvals have been completed, the document is now in “Effective” status and can easily be found by searching the documents tags, roles, tasks, or any keywords.  

Final Thoughts 

While SOPs and WIs share similarities, it’s important to understand the differences. Clearly written WIs are detailed step-by-step guidelines used to minimize errors by enhancing safety, efficiency, consistency, and productivity.  

By leveraging eDMS solutions such as Veeva Quality Docs, organizations can ensure users have access to standardized instructions that support consistent training, improved quality, and overall operational excellence. To discuss best practices for WIs or how digital solutions like Veeva can support your operations, connect with our team today. 

Contributions by Nikki Trammel  

The post Writing Clear and Actionable Work Instructions for Veeva Vault Users appeared first on Clarkston Consulting.

Download the S&OP Process Assessment for a CPG Manufacturer Case Study Here

A leading global manufacturer of natural extracts and ingredients used in food, beverage, and personal care products engaged Clarkston Consulting to improve its supply chain performance. The client was facing increased customer dissatisfaction due to rising lead times and excessive inventory. In response, executive leadership initiated an assessment of their global, cross-functional Sales and Operations Planning (S&OP) processes, seeking actionable recommendations to support a new market growth strategy while improving sales and profitability. 

Although the client initially believed that process-level improvements to S&OP were the primary need, early findings revealed deeper systemic challenges. These included misalignment between business and supply chain strategies, inconsistent education and adoption across teams, lack of formalized processes, and weak sustainability mechanisms. Clarkston recommended a more holistic and phased approach to transformation. 

Leveraging its proven IBP/S&OP assessment methodology, Clarkston conducted a comprehensive review of the client’s current-state processes, tools, performance metrics, and organizational alignment. The approach included in-depth interviews and a multi-dimensional benchmarking analysis to position the client’s capabilities relative to peers and industry best practices. 

Clarkston delivered a future-state roadmap that detailed the tactical and strategic steps required to build a sustainable, integrated S&OP capability. The roadmap emphasized cross-functional alignment, technology enhancement, change management, and organizational readiness, ensuring long-term value capture. The recommendations also integrated the client’s growth vision and provided a clear case for change with associated cost-saving and profitability levers. 

Upon implementation, the client is expected to achieve a 20–35% improvement in profitability through enhanced opportunity sales, working capital reduction, and increased customer satisfaction. By partnering with Clarkston, the client now has the strategic foundation, execution plan, and internal alignment required to transform S&OP into a driver of business growth and operational excellence. 

Download the S&OP Process Assessment for a CPG Manufacturer case study, and learn more about our S&OP Consulting Services by contacting us below. 

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Contributions by Cathi Henriquez

The post Conducting an S&OP Process Assessment for a CPG Manufacturer appeared first on Clarkston Consulting.

The traditional roles of both Quality Control (QC) and Quality Assurance (QA) within life sciences manufacturing have complimentary operational functions with the goal of ensuring product safety and quality; however, they do this through different approaches and focus.  

The QA role defines procedures and standards to reduce any defects in the manufacturing process, whereas the QC role identifies defects through testing samples through the production lifecycle to ensure the values fall within the respective specification limits. Both roles are critical to ensuring organizations consistently develop and manufacture safe, effective, and high-quality products.   

While in the past these roles have been reliant on manual, paper-based processes with large amounts of data, technological advances in systems and applications have introduced a great deal of automation. This piece explores the impact of automation on QC and QA functions, its benefits and challenges, and considerations for organizations looking to get started. 

Benefits of Automation 

In the QA and QC space, adding automation eases the burden of time-consuming tasks and increases data integrity. Whether simple or robust, the value and throughput gained is usually significant. Some examples:  

• Instrument interfacing eliminating the need for transcribing results  
• Electronic Laboratory Notebooks (ELNs) to remove the paper-based lab notebooks  
• Laboratory Information Management System (LIMS) to perform calculations automatically when results are entered  
• Review by Exception to allow for systematic release of data when specification criteria is met 
• Advanced Analytics for predicting potential quality issues  
• Robotics for routine tasks such as sample preparation  
• System integration for real time data transfer between systems 
• Automated reporting such as Certificate of Analysis (CoA) and email notifications of product release 

These examples have undeniable benefits for any organization by adding efficiency to these workstreams. Automating repeatable tasks allows time for personnel to focus on other areas such as drug discovery, product improvement, or process standardization. Predictive capabilities can stop issues before they happen resulting in reduced product loss. These benefits also enable resource optimization while decreasing the risk of waste. 

Risks of Automation 

Automation should be considered as an enhancement to the QA and QC functions, however, there are some challenges associated with automation. Process automation requires investment in current or new systems and technologies. Additionally, leadership buy-in is critical, and Return on Investment (ROI) should be carefully evaluated.  

System errors may occur, such as background rounding causing a false compliance; therefore, careful and robust validation efforts must be adhered to. And it’s important to have a detailed disaster recovery plan in the event of a system failure causing a return to manual processes. 

Considering Automation for QC and QA 

If your organization is considering automating processes for QC or QA, Clarkston Consulting can help throughout the project lifecycle from identifying inefficiencies, analyzing opportunities for process automation, and gathering requirements to implementation, validation, user adoption, and hyper-care. 

Contributions by Roderick Anderson, Anjali Chhamunya, Frank Kovach, Ayan Mohamud, Liz Mancio, Wayne Hurd, Olivia DeFrancesco, Charles Webb, Eric Borries, Nicole Sharp, Jonathan Benincosa, Josh Edwards, George Adams, Elizabeth Pegram 

The post The Impact of Automation on QC and QA Roles  appeared first on Clarkston Consulting.

Download the Custom Product Owner Training Case Study Here

The client, a biotech company, was transitioning their IT team to a product-centric model focused on agile methodology, stakeholder engagement, and product team leadership.  

In the product owner model, individuals are assigned a product or series of products that they’re responsible for owning and ensuring that they’re maximizing the value of the product and its outputs for the company. As a product owner, leaders are accountable to key stakeholders, the development team, and the overall business.  

The client had recently adopted this model and aimed to better empower leaders within the team to take ownership of their products. However, key leaders and workstream owners had varying understandings of what it meant to be a product owner, including their roles, responsibilities, and how to drive progress effectively. To address this, the client sought Clarkston’s support to better equip the team and to develop and deliver a scalable training aligned with their long-term organizational transformation goals and to support enterprise-wide adoption of the product model. 

Through close collaboration with IT stakeholders, the Clarkston team identified key challenges and opportunities for consistent messaging and designed a custom seven-module training covering the full product management lifecycle, from defining product visions to building roadmaps, collaborating with stakeholders, and everything in between.  

The 1.5-hour sessions were delivered over four weeks and included application-based activities to ensure attendees left each session with tangible tools and takeaways to apply with their teams. The training also provided templates for everyday use and was complemented by weekly “office hours,” offering a casual space for participants to ask questions and discuss real-world scenarios. The training also included weekly recap emails, with additional resources, templates, and articles designed to reinforce key concepts delivered in training. 

As a result, IT team leaders left the training empowered to own their products, with 100% of participants reporting increased confidence in their product ownership capabilities. This foundation positions the client to successfully sustain and scale their product model moving forward. 

Download the Custom Product Owner Training case study, and learn more about our Training + Change Enablement by contacting us below. 

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However, as the industry moves toward focusing on revenue growth management (RGM) – a broader evolution of trade promotion management that focuses on a more holistic view of a CP organization – there’s also a need for a more holistic view of product assortment that drives toward consistent understanding, planning, and execution around assortment to drive better organizational success. Below, we’re unpacking how to holistically approach your CPG product assortment strategy.

Taking a Holistic Approach to CPG Product Assortment 

For CP companies, this means thinking more holistically about what role products play at the various retailers to which an organization sells. Sure, promotion plans will still play a large role in how we think about assortments, but now CP organizations should also be looking at and asking other questions, like:  

• Is there a product missing that my competitors are selling? 
• Are there enough unique items that are special to my brand as opposed to a different brand? 
• What are my “loss leaders” (products consumers will specifically go into a store for when on discount) vs. my “hero products” (products that will always make money; a brand’s calling card)? Do I have the right combination of these to drive revenue? 

Even when taking assortment out of the context of TPM or TPO, a number of CP organizations think of it simply as “price pack architecture (PPA).” Even then, when they think of PPA as it relates to their products, they typically only look at it from “look and size” – how does the product look, and how many sizes should we offer this to consumers?  

Moving Beyond Look and Size 

As we take our thinking to the next level with RGM, we can also evolve our thinking about assortment beyond this basic understanding of price pack architecture – looking at your portfolio and optimizing the products within it. Brands can go past just offering different looks and sizes for products and instead dive deeper into the “why” of your brands and “what” your consumers are looking for.  

We encourage companies to invest in PPA to drive towards a better understanding of what value consumers are seeking from the various features and benefits of their products as well as what value these same consumers see from the features and benefits competitor products may provide. 

Consumers are looking for products that will meet their evolving needs, and sometimes those are needs that they didn’t even realize they had. If a product can provide value by addressing those needs, consumers will pay for it and pay extra. For example, if a consumer is looking at two cans of beans, both of similar size, but one can has a pull tab for convenient opening but the other doesn’t, the odds are the consumer will pay the extra few cents for that feature even though the products are essentially the same look and feel. 

Assortment is changing alongside the industry as we move from trade promotion management / optimization to revenue growth management, but functionally, where does that leave you as an organization? Where do you and your brand’s processes fit in the maturity model or future of assortment?  

Let’s break it down into three categories below: (1) the foundational activities brands should be doing with product assortment; (2) leading edge product assortment processes to drive revenue successfully; and (3) the future of product assortment. 

Foundational Assortment Activities 

At a minimum, your organization should have a structure or process to look at your portfolio from the brand lens as well as the customer lens to identify the key roles that your products are playing. Below are some sample activities to help your organization determine if you’re reaching this foundational level: 

1. Understand the role of your products at the retailer for the organization as well as for the consumers 
2. Structure your product groupings in a way that allows for operational planning and trade planning 
3. Keep the consumer front and center throughout all your planning and strategizing 
4. Invest in understanding existing price pack architecture 

These activities will help you review and evaluate the value proposition that your brand and products are providing to consumers. Price is not always correlated to size; in fact, today, many consumers will pay more to get less if it makes sense for their needs (i.e., help with portion control, limiting indulgence, etc.)    

Leading Edge Activities 

If you’ve completed the above activities confidently and accurately, your brand is on its way to being leading edge with product assortment. The next step, however, to truly be at the leading edge of product assortment activities is to be able to connect all these data points to then take back to your product marketing teams. Some sample activities to bring your organization to the leading edge of product assortment: 

1. Conduct an advanced PPA review to optimize your pricing against features and benefits 
2. Coordinate your product development process to take advantage of blank spaces identified 
3. Refine your organization’s price and promotion planning to optimize margins for the manufacturer and the retailer (ex. Are you simply subsidizing existing buyers or are you stimulating new or incremental purchases?) 

Future of Product Assortment 

If you’ve completed all the activities in the leading edge section, chances are your product assortment processes are more mature than most other brands. So, how do you stay leading edge to ensure continuous revenue growth for your brand? What does the future state of product assortment look like at CP organizations? 

From our perspective, the future state of effective and mature product assortment processes looks like: 

1. High coordination and alignment internally between all cross-functional teams 
2. Leveraging technology and tools to streamline the reporting process to allow focus on the analytics and identification of opportunities 
3. Performing regular reviews of your company’s product assortment to stay on top of competitor and marketplace trends – and being able to quickly put those into action with your product development process 
4. Developing aligned price and promotion strategies so that your organization isn’t leaving any money on the table 
5. Engaging regularly with consumers and retailers to get feedback and avoid siloed thinking and actions 

If you’re able to look at the category overall and see the trends with consumers and competitor brands, what will start setting your brand apart from competitors is how quickly you can deliver those insights to your product innovation / product development teams to act on it and get a new product on the shelves to address those new consumer needs. 

We’re beginning to see more tools pop up to help with driving insight development and delivery as the analytics field becomes more accessible to brands (data & analytics departments have grown over the last 10 years as well as the increased mainstream usage of generative AI). However, brands – especially younger brands – need to have access to data that are beyond just their own data.  

If you’re looking at just your own brand shipment data, you likely will never understand the role your product is playing at a retailer because you can’t look at the category from a holistic perspective and see how your products compare to others. If you can see those holistic insights for a product or a category and quickly transition those to your product development team, your brand will continue to grow and resonate with consumers. 

If you’re experiencing any of these challenges with your product assortment process, you can check out our comprehensive list of trade and RGM services here. 

The post Thinking Holistically About Your CPG Product Assortment Strategy  appeared first on Clarkston Consulting.

To ensure this, knowledge transfer processes and documentation are key. Effectively transitioning knowledge from the project team to the business users requires a well-defined plan and comprehensive reference documents. Below, we dive deeper into the importance of knowledge transfer for an ERP implementation and explore some best practices for establishing and documenting these knowledge transfer materials.  

ERP Knowledge Transfer Essentials  

A Knowledge Transfer List can serve as a comprehensive guide for effectively transferring critical ERP system knowledge between teams and organizations. Documents on this list are essential for ensuring that all stakeholders – new team members, end users, or external consultants – are equipped with the necessary information to understand, operate, and optimize the ERP system.  

By organizing this information systematically, the Knowledge Transfer List helps streamline the transition process after an ERP implementation, minimizing operational disruptions and ensuring that the ERP system is utilized efficiently and effectively across all business functions. 

Below are some key elements to include with the Knowledge Transfer List as part of any ERP project. These documents may have tags with links to other documents/development objects: 

Ensuring Long-Term System Success 

Comprehensive documentation across key areas—design, system processes, data migration, training, change control, batch jobs, and reporting—is crucial for the success of an ERP implementation. Well-defined documentation supports knowledge transfer, user adoption, and system sustainability, ensuring smooth operations and adaptability to future changes. It serves as a vital resource for troubleshooting, continuous improvement, and long-term system success. 

Reach out to us today to learn more about knowledge transfer documentation for SAP projects. 

 Contributions by Anil Khetpal 

The post The Importance of Knowledge Transfer for an ERP Implementation appeared first on Clarkston Consulting.

New Jobs 

Over the past 15 years, eCommerce has created more than 178,000 new jobs, and it’s projected to continue growing around 5% in the coming year. AI is also transforming roles by automating tasks such as inventory tracking, fulfillment, transaction processing, and customer service.   

As a result, retail job functions are shifting, and new roles are emerging – eCommerce specialists optimizing online platforms, UX designers enhancing the digital shopping experience, data analysts interpreting customer behavior, and cybersecurity architects protecting sensitive information. At the same time, frontline associates are increasingly expected to use digital tools to meet customer expectations. In fact, 54% of shoppers want associates to carry a mobile device so they can check inventory or quickly access loyalty account information.  

For retail store associates, this presents an opportunity to upskill and step into more digitally enabled roles, bringing frontline knowledge (like the goals and mission of the business) into this evolving digital landscape. This also benefits employers, too, who retain knowledgeable staff while closing skills gaps.  

This shift is not only driven by technological advancement but also rising consumer expectations and the need to streamline operations and reduce costs. At the same time, digitalization does come with trade-offs. The rise of eCommerce has contributed to many retailers closing stores – with up to 15, 000 projected to close in 2025, more than double in 2024, resulting in thousands of lost jobs.  

Still, for many retailers, digital transformation is less about job elimination and more about job evolution, creating new opportunities for growth, reskilling, and long-term workforce development for their retail associates.  

Embracing vs. Resisting Change 

It’s important to consider that not all employees may be embracing this digital transformation. While turnover is already common in the retail industry, the introduction of new technologies can accelerate it, especially when employees feel overwhelmed or excluded from the change.  

Employees may resist learning new processes or adopting unfamiliar systems, like AI-powered tools, mobile devices, RFID inventory scanners, or self-checkout solutions. Veteran staff can feel wary AI is unreliable or will disrupt their jobs significantly. Some may even choose to leave rather than invest time in learning technologies they don’t understand or trust.  

To reduce this resistance and better retain those experienced team members, management needs to clearly communicate the why behind the digital transformation and how it aligns with the organization’s vision or mission. They can also provide hands-on training that creates new opportunities in the employees’ work, empowering them to use the new tools effectively and see how their roles are evolving (not being replaced). In-store associates, for example, should feel confident assisting at self-checkout, using RFIDs to load inventory, or helping customers shop or browse via mobile devices.  

When digital tools are properly introduced and enough training is given on the devices, they can actually help to reduce repetitive tasks and minimize burnout for employees, freeing them up to focus on more personalized, rewarding experiences with customers. This not only increases productivity and sales but can also improve the overall employee experience, leading to more engaged and satisfied associates. 

How to Address Evolving Talent Needs in Retail 

As the retail industry undergoes rapid digital transformation, workforce strategies must evolve in parallel. From AI-powered tools to enhanced eCommerce platforms and in-store technologies, these shifts demand new skill sets, as well as a fresh approach to talent development. Retailers that prioritize people as much as platforms will be best positioned to adapt and grow. 

Talent Management Strategies  

1. Invest in change management 

As retailers adopt new technologies to optimize stores and enhance customer experiences, the skills required of employees continue to shift. Prioritizing talent management as a core part of change management signals to employees that leadership is invested in their growth and success. Clear goals around AI and eCommerce adoption, combined with a thoughtful upskilling strategy, help employees embrace change and stay motivated to develop new capabilities. 

2. Prioritize digital upskilling as core parts of transformation. 

Digital upskilling must be central to any retail transformation. Once the organization defines a clear purpose for digitalization, ensure all employees understand the vision and feel part of a unified effort. Before investing in digital tools or AI, establish a plan to build digital literacy across the workforce. These technologies provide the most value when employees are confident in and capable of using them. While transformation can raise concerns around retention, LinkedIn research shows that 94% of employees are more likely to stay when offered learning and development opportunities.  

3. Design workforce strategies that are human-first but tech-enabled. 

Effective digital training starts with helping employees understand the “why” behind the change and the value it brings to them. Building digital confidence empowers employees and fosters a willingness to engage with new systems. Leadership participation, clear communication, and empathy throughout the process help create a positive learning environment—and ultimately, a more future-ready workforce.  

Looking Ahead 

Digital impacts are significant in retail and while jobs are not being replaced, they are changing. With the proper strategy and training when implementing digital tools and systems, management can make this a win for the customers, employees, and company. Talent management can be a differentiating factor for retailers moving forward to keep engaged, skilled, and motivated associates. Reach out to learn more about our People and Change Consulting. 

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