Setup and Implementation of Digital Validation Tools (DVTs) for Pharma Manufacturing (Part 2)

Speed means nothing if you can’t prove compliance – and DVTs let you do both. When you are responsible for validation in pharmaceutical manufacturing, you want processes that are fast and consistent. That’s exactly what Digital Validation Tools (DVTs) help you achieve. 

These platforms digitalise and automate the paper-based workflows of validation – requirements, testing, traceability, approvals – for easy management in one controlled and audit-ready environment.

In simple terms, implementing a DVT means you’re building a structured digital foundation that standardizes validation from end to end. When done right, DVTs shorten validation processes and give working teams the transparency they need to work efficiently.

Key Takeaways:

• DVTs streamline validation. They automate requirements, testing, traceability, and approvals within a single audit-ready platform.
• A risk-based assurance approach, guided by ISPE GAMP 5, helps the validation efforts be proportional to GxP impact and to avoid unnecessary full CSV.
• Clear governance and a structured implementation roadmap keep DVTs compliant and aligned with lifecycle expectations.
• Continuous KPI monitoring and periodic reviews sustain long-term system performance and validation integrity.

How should you structure digital validation?

You support pharmaceutical manufacturing by implementing DVTs to centralize validation activities across your GxP computerized systems and the entire system life cycle. They automate processes such as requirements management and configuration management.

You must use a risk-based assurance approach instead of full computerized system validation (CSV) for these tools. A full CSV is only required if the tool directly supports a GxP-regulated business process or maintains GxP records that directly support the product life cycle. For validation tools that merely support the validation or IT processes, managing them through routine company assessment and assurance practices and applying good IT practices is sufficient, according to the ISPE GAMP 5 Guide. 

To structure effective risk-based assurance for your DVTs, you should focus your efforts on the following key activities: [1,2]

Step 1: Setting the foundation – requirements and scope

As detail-oriented professionals, you understand that defining the foundation for your digital validation system requires applying critical thinking and a scalable, risk-based approach. 

Your documented requirements form the basis for system qualification and validation. These requirements must safeguard product quality and data integrity. Compliance requires integrating principles like ALCOA+ (which ensures data trustworthiness) and meeting regulatory requirements outlined in EU Annex 11.

The scope of compliance activities should align with system function:

• CSV: This framework achieves and maintains compliance throughout the system life cycle.
• Commissioning & Qualification (C&Q): For automated manufacturing equipment, a separate CSV should be avoided. Instead, integrate the system specification and verification within the engineering approach to ensure fitness for use of the complete equipment.
• Process Validation (PV): Fitness for intended use can be demonstrated via documented engineering and project activities, along with subsequent process validation.

Applying this structured approach leads to building a robust and auditable foundation. This allows focusing resources where the risk to GxP computerized systems is highest. [1,3]

Step 2: Forming the user and technology landscape

For the patient and public health

The overarching purpose of all GxP activities is the protection of public health. This is achieved by guarding patient safety and product quality. The core risk is the potential for harm resulting from inappropriate compliance measures.

For the executive (management & strategy)

Executives are responsible for establishing organizational policies and providing sufficient resources for system implementation. A key goal is achieving robust compliance cost-effectively. This must be done with the support of innovation and technical advancements. The efficient use of valuable resources includes applying practices that are proportionate to the assessed risk and avoiding rigid compliance methodologies.

For the Quality & Compliance Professional (process owner/quality unit)

The process owner is ultimately responsible for ensuring the system is fit for its intended use. The independent quality unit is responsible for setting policy and reviewing key quality-critical aspects of the system. These professionals must apply critical thinking and a scalable, risk-based approach throughout the life cycle to focus compliance efforts where the risk is highest. 

For the technical expert (system owner/IT/SME/supplier)

The system owner is accountable for the system’s availability and maintenance during its operational life cycle. Subject Matter Experts (SMEs) play a crucial role by taking the lead in system verification based on process understanding. Technical teams are strongly encouraged to adopt modern, efficient development methods like Agile approaches. [1]

Digital maturity and data integrity by design are considered essential enablers to establishing an effective digitalization strategy. Organizations aiming to enhance this capability may utilize schemes such as the Capability Maturity Model Integration (CMMI). It provides a framework for assessing and improving organizational capability and maturity at every level. 

For sustainable digital maturity, you must also plan for seamless data integration with existing systems such as Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) platforms to maintain consistent data flow across the full validation ecosystem. [4]

Step 3: Choose and qualify the solution

When you compare different DVTs, look beyond features and evaluate how well each vendor supports your User Requirements Specification (URS). Configuration and Design Specifications (CS/DS) expand upon the URS with validation solutions that fulfill both the specifications and requirements. 

Effective vendor management begins with a formal supplier assessment to confirm their quality capability based on the system’s risk. The security posture has to meet Recovery Point Objectives (RPO) and Recovery Time Objectives (RTO). This includes a risk-based approach to address security vulnerabilities and technical controls like role-based security to safeguard data integrity and keep system uptime.

Step 4: Establish ownership and governance

Effective DVT implementation starts with clear ownership and strong governance. GAMP 5 highlights the need to define roles, responsibilities, and oversight to ensure systems remain compliant throughout their lifecycle. This includes setting template standards, managing controlled documents, and applying a structured, risk-based change control process.

Your governance team should include:

• Sponsors and Stakeholders – senior leaders who set direction and ensure alignment across business, quality, legal, engineering, and IT groups.
• Project Team – project manager, SMEs, quality, IT, and engineering, responsible for planning, compliance, and lifecycle deliverables.
• Users – process owners and key users who define requirements and help verify the system remains fit for intended use.

This structure ensures DVTs operate under consistent standards and remain compliant and controllable over time. [1]

Step 5: Execute implementation

Executing a successful DVT implementation requires a structured, phased roadmap that keeps your team aligned from the first planning step to full deployment. Start by defining clear objectives and scope, then assess risks and system adequacy to ensure the tool supports your intended processes. 

After configuring the system and setting access controls, run a focused pilot at one site or for a single process to validate usability and workflows. Once refined, roll out the solution organization-wide and follow with a post-implementation review to drive continuous improvement. Along the way, highlight quick wins – like faster approvals or timely dashboards with the real-time validation systems. That maintains momentum and reinforces the value of your digital validation program.

Step 6: Evaluate and optimize post go-live

The operational phase, often the longest period of the system life cycle, requires continual evaluation and optimization for maintaining regulatory compliance and approval.

• Track KPIs: Tracking performance metrics, such as Key Process Indicators (KPIs), system and data availability, downtime, and incident trends, is essential for monitoring operational effectiveness and identifying where improvements are needed. These metrics provide objective measures of process quality.
• Gather feedback and feed into governance meetings: Feedback and input for improvements should be gathered systematically through periodic review and evaluation. It should include data gathered from incident and problem management and Corrective and Preventive Action (CAPA) processes. This way, the management can focus on improving the efficiency of ongoing support and quality processes.
• Plan periodic requalification after updates: The periodic review process verifies that the system remains validated following changes. The rigor of the change management approach (including required regression testing) should be based on risk to minimize the need for full revalidation.

Implementation of these processes helps the organization have continual improvement, proactively enhancing product quality and efficiency.

Partnering for a patient-centric future

Having the right technology partner becomes essential, as pharmaceutical manufacturing and life sciences companies continue moving toward automated and insight-driven operations. 

With the combination of robust engineering and quality-driven processes with a focus on patient safety, BGO Software supports your journey toward a digital transformation. Let Digital Validation Tools be the catalyst for better outcomes. Contact us today!

References:

[1] International Society for Pharmaceutical Engineering (ISPE). (2022). GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). International Society for Pharmaceutical Engineering (ISPE). https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition 

[2] Ullagaddi, P. (2024). A Framework for Cloud Validation in Pharma. Journal of Computer and Communications, 12, 103–118. https://doi.org/10.4236/jcc.2024.129006

[3] European Commission. (2011). EudraLex Volume 4 – Guidelines for Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use, Annex 11: Computerized Systems. Retrieved from http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

[4] Snowdon, A., Hussein, A., Olubisi, A., & Wright, A. (2024). Digital Maturity as a Strategy for Advancing Patient Experience in US Hospitals. Journal of patient experience, 11, 23743735241228931. https://doi.org/10.1177/23743735241228931

Dobrin Kolarov

Healthcare business analyst with expertise in marketing and business development, and holds an MPharm degree. He specialises in creating and executing communication strategies that make digital health solutions and pharmaceutical technologies clear, accessible, and resonation for their audiences.