Digital Commissioning, Qualification, and Validation in Large Capital Projects

Manual routing, sequential reviews, and fragmented documentation slow progress and increase risk, often turning CQV into the critical path that delays projects and speed to market.

Background

The risk-based quality risk management (QRM) process from the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)1 has been well documented to let projects focus on assessing and testing key qualification aspects related to critical process parameters (CPPs) and critical quality attributes (CQAs) and to not qualify everything. This article will focus on how the digital validation tools enabled by the digital validation tools (DVTs) guide can complement and enhance this approach.

DVTs are a transformative approach that replaces cumbersome paper processes with streamlined data-driven workflows. By digitizing validation from planning through execution, DVTs deliver faster cycle times, improved audit readiness, and global standardization, all while reducing life cycle costs.

Key Project Deliverables

For large paper-based projects, the effort required to deliver the number of documents for each step of Figure 1 is massive. The management of planning documents—such as user requirement specification (URS), system classification, system risk assessment, design qualification, start-up/test/adjustment, and C&Q test documentation—are increasingly time-consuming as the project life cycle advances. This is because of increasing oversight and increasing complexity. Furthermore, the documentation from a supporting engineering/commissioning/construction perspective and the total document effort requires a large team to manage and track for a large project. Key concepts around document management and handing for a paper process follow.

Routing

Manual routing of validation documents via email or interoffice mail can cause delays and make it difficult for reviewers and developers to access the latest versions. These delays hinder the development process. In contrast, electronic workflows simplify document sharing, ensuring that teams can enforce requirements consistently throughout the development life cycle and avoid last-minute issues. Electronic routing also allows for tracking document ownership and reducing the risk of lost files.

Data Entry

Paper-based workflows often require data entry into word processors or spreadsheets, followed by printing, paginating attachments, and archiving. These time-consuming tasks divert skilled quality assurance staff from high-value activities. Digitizing the data collection process eliminates these steps, enabling practitioners to focus on tasks such as risk assessments. DVTs also provide real-time visibility into the progress of the validation effort and can easily generate reports and metrics for faster decision-making.

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Reviewing and Analysis

Paper documents allow only one reviewer at a time, requiring sequential reviews for effective version control. This process can be complicated by the presence of multiple document copies. Digital validation enables simultaneous authorship and editing by multiple reviewers, with version controls that track who made which changes and when while automatically creating an audit trail.

Notification

Paper-based reviews are slow, requiring reviewers to wait for physical documents. DVTs offer real-time alerts for document readiness and task assignments, allowing reviewers to accept or decline tasks immediately. This enables efficient task reassignment and minimizes delays.

Traceability Matrix

In paper-based workflows, traceability matrices are often neglected until the end of the validation process, risking errors because of complexity and time constraints. Digital workflows integrate traceability throughout the project, enhancing validation and software test efficiency and accuracy. Digital trace matrices can be maintained more easily and can be used for future change management, rather than simply as documentation for completed validation.

Discrepancy Handling

Deviations and exceptions are time-consuming and hard to track in paper-based systems. Digital workflows streamline deviation management, allowing for concurrent handling and faster execution. Digitization ensures traceability of each deviation and validation change, improving issue resolution and maintaining product quality compliance.

Source of Truth

Paper-based workflows require physical copies, which increases the risk of loss or security issues. DVTs provide a secure, centralized “source of truth” with role-based access controls. Virtual access eases global collaboration, saving time and enhancing security.2

DVTs offer real-time alerts for document readiness and task assignments, allowing reviewers to accept or decline tasks immediately. This enables efficient task reassignment and minimizes delays.

Project Key Performance Indicators

Business metrics and key performance indicators (KPIs) should be applied across all documents in the project life cycle to track progress against the approved time schedule. Documents to track will include C&Q plans, URS, system classification, system risk assessment, design qualification, commissioning, and sometimes more (see Table 1).

How to Leverage a DVT for Efficient Project Execution

When managing a large pharmaceutical CapEx project, it is increasingly clear that leveraging DVTs brings significant benefits—provided the implementation is done well.

Faster Speed to Market

On large CapEx projects in which C&Q often become critical path items, reducing cycle times directly shortens the schedule, allowing faster start‑up, earlier production, and faster speed to market. DVTs streamline the C&Q and validation processes of equipment, facilities, and utilities by digitizing the entire life cycle—from planning through execution to reporting. By replacing traditional paper-based workflows with fully digital systems, organizations reduce manual handoffs, quicken review cycles, and reduce delays caused by physical signatures or document transfers. The ISPE white paper “Digital Validation – Future Advances”3 highlights that improved access to digital data generated during C&Q enables seamless data transfer to downstream functions such as maintenance and calibrations. This enhances cross-functional efficiency and supports the long-term management of the validated state.

Improved Data Integrity

DVTs offer audit-ready electronic records with built-in audit trails, version control, electronic signatures, and structured workflows, enabling real-time status visibility and automated traceability throughout the validation life cycle. The iSpeak blog “Validation in Transition: Why 2025 Is the Turning Point for the Industry”4 notes that audit readiness has now surpassed compliance burden as the primary challenge that validation and quality assurance (QA) teams face—an area where DVTs clearly provide significant support. By enabling continuous oversight rather than relying on periodic, manual validation activities, DVTs help ensure that complex systems such as utilities; automation platforms, supervisory control and data acquisition (SCADA), and building management remain in a validated state. For large CapEx projects, this reduces the risk of inspection findings, avoids costly rework, and supports a smoother, faster handover to operations.

Standardization Across Sites

In multisite pharmaceutical companies—particularly during large CapEx expansions or global rollouts—DVTs provide critical standardized templates, consistent workflows, and harmonized documentation and reporting. This level of standardization helps reduce duplication of effort, minimizes site-to-site variability, and accelerates the deployment of new production lines or facilities. When CapEx projects involve replicating lines or developing global “fleet” facilities, using DVTs ensures more efficient and consistent validation.5 This results in faster execution, quicker learning for project teams, and fewer validation errors across sites.

Better Visibility, Project Oversight, and Decision‑Making

With DVTs, project leaders and quality/validation leads can monitor validation activity progress in real time (e.g., which protocols are complete, which equipment is signed off, what remains open, status of outstanding deviations/change controls) rather than rely on static spreadsheets or paper binders. For a large CapEx project, this improved visibility helps keep the project on schedule and enables earlier escalation of problems.

Life Cycle Cost Reduction and Operational Handover Benefits

Although a CapEx project focuses primarily on the build and initial validation, the long-term value of DVTs extends well into operational phases. These tools support the full validation life cycle, including change control, requalification/periodic review, and continuous monitoring. This ensures systems remain in a validated state over time. By capturing digital records from day one, future modifications—such as scale-ups, process changes, or utility upgrades—can be executed more efficiently and with greater traceably. Also, the reduction in manual tasks, such as searching through paper binders or performing duplicative reviews, lowers operational costs. For CapEx projects, this reduces total cost of ownership and yields faster return on investment.

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Knowledge Management

DVTs are not only tools for faster validation; they enable organization-wide knowledge management by capturing and structuring senior subject matter experts’ collective experience and making it accessible to everyone in the organization. In doing so, these tools reduce risk, improve efficiency, and support strategic decision-making across the life cycle of pharmaceutical facilities and products. (See Figure 2.)

For large CapEx projects, particularly those involving new facilities designed to be “smart,” “connected,” or “digital-first,” DVTs align seamlessly with the broader goals of Pharma 4.0™, which emphasize integrated systems, real-time data connectivity, and readiness for continuous manufacturing. The Pharmaceutical Engineering® article “A Pharma 4.0™ Future for Brownfield Challenges” 7 highlights the limitations of legacy systems and underscores the importance of conducting digital maturity assessments early in a project to avoid falling behind. Furthermore, the ISPE white paper “Digital Valida-tion – Future Advances”3 introduces Validation 4.0, a concept incorporating machine learning and data-driven validation approaches as the next evolution in compliance and efficiency.

By integrating DVTs early in the CapEx project (ideally from the initial design phase), organizations can avoid costly retrofits and ensure the facility is future-ready. Willingness to engage with DVTs should be considered a critical factor when selecting vendors and suppliers. The project’s success will hinge on DVT engagement from all vendors and suppliers.

This proactive approach reduces long-term risk and enhances agility, enabling faster adaptation to regulatory changes, technological advancements, or market demands. Ultimately, early adoption of digital validation is a strategic enabler for building digitally mature, compliant, and high-performing pharmaceutical manufacturing environments.

Engineering Construction and Commissioning Documentation

DVTs can be useful for managing large volumes of project, vendor, and engineering documents, Enabling vendors, suppliers, constructors, and engineering companies to use DVTs is important for an efficient outcome, and this should be considered upfront in contractual negotiations. A DVT can be used as an intermediate location before migration to an engineering information management system and/or a computerized maintenance management system.

If the DVT will be used as the final repository for this documentation, using a cross-referencing function within a DVT can be very powerful; any source documentation required as evidence can be linked to the original engineering record and minimize the upload of attachments. There are two ways to leverage a DVT for engineering, construction, and commissioning documentation.

First, the DVT can be used to store legible/readable scanned paper records utilizing the DVT workflows to review and approve. This method makes finding and extracting relevant details inefficient and time-consuming, which slows workflows and increases the risk of overlooking critical data.

Second, documents can be drafted natively in the DVT, and a DVT document template can serve as a wrapper and thus allow content to stay in pre-defined formats and structures, allowing searchability within the same platform and thus increasing efficiency. This second option is the preferred choice for speed and efficiency, but this may not always be possible, so combining options one and two may be necessary. Any leveraging of the power of the DVT is a huge step up from paper.

The documents to be considered for inclusion in a DVT for a large project are as follows:

• Engineering technical specifications
• Design specifications
• Functional specifications
• Design review
• Commissioning plans
• Commissioning/FAT/SAT documents
• Engineering turnover packages
• Vendor turnover packages
• Construction turnover packages
• Receipt verification
• Mechanical completion verification

DVTs are not only tools for faster validation; they enable organization-wide knowledge management by capturing and structuring senior subject matter experts’ collective experience and making it accessible to everyone in the organization.

DVT Integrations and Digital Dashboards

Integration initiatives are designed to create a seamless digital ecosystem across project tracking, commissioning, qualification, and validation (CQV), execution, and reporting. By connecting DVT platforms with real-time execution tracking, CQV activities, project milestones, and tech transfer, deliverables are now visible in synchronized dashboards. This ensures that operational data, validation documentation, and execution align while enabling proactive oversight through updated risk registers and digital S-curves, which highlight planned versus actual progress. These integrations also leverage client digital tenancies, connected via APIs to internal and external software systems. This unified environment allows for streamlined data flow, consistent reporting, and enhanced visibility across CQV and project stakeholders. See Figure 3 for a comparison of a DVT approach vs. a traditional approach.

Conventional Cost Savings

In the engineering C&Q space, digital validation has supported the pharmaceutical industry for more than 10 years, and the number of users using these tools has accelerated over the last five years. During these recent years, several companies performed return on investment calculations, looking closely at cost and schedule metrics at the protocol level. Feedback across the industry has consistently reported gains in the cost of content creation (protocols and reports) in the range of 25%–45%, and gains in schedule (time to deliver content) in the range of 40%–70%.

Anecdotal feedback in the C&Q space reports that with increased use of these tools, taking advantage of standardized approaches to content that can be duplicated across equipment categories (think multiple cloned protocols supporting like-for-like equipment), consistently generating increased productivity gains compared to those mentioned previously.

We hear similar feedback from our stakeholder partners in QA, engineering, facilities, process validation, and quality control. One common observation includes a significant reduction in the review-and-approve cycle time that focuses on good documentation practices and reduces the number of meetings required to see work product through to completion. Another common observation, and one that reinforces the power of digital protocol practices, is the parallel ability to route content for review and approval. One last common observation is that paper protocol practices require keeping master and working documents, managing unique protocol numbering, and archiving paper content (locally and remotely) that must be readily retrieved in support of regulatory audits.

Future Advances

Looking ahead, what is next for digital validation improvements? Where will we see our future gains? With the explosion of generative artificial intelligence (AI), it is natural to assume that machine learning will deliver future gains. Closer examination of this point shows that although there will be gains, they will be proportionately less significant than the gains from transitioning from paper to digital. Consider this: With the digital tools and best practices we have developed over the past few years, we have dramatically reduced waste and inefficiency. Improvements in the protocol space are smaller than they have ever been: Using paper we may have been 50% efficient, but in digital validation we can improve our efficiencies to 95%. This leads us to the question: is there business value in investing in the high costs of generative AI development (considering that pharmaceutical companies cannot use public AI models due to strict data privacy and regulatory constraints) to improve productivity another 2%? At the protocol level, companies that are looking at this business case have not yet committed to generative AI for creating content. Is there room for improvement? Two promising areas for significant gains are in large capital projects and in adopting data-centric approaches to digital validation.

Gains in the large capital project space will manifest first in project benchmarking, where project teams estimate the costs and schedule requirements for all elements of a project—including validation. As a community, C&Q teams are frequently not consulted at the early stages for large projects and the resources and time required may be significantly underestimated. DVT and practices allow us to accurately benchmark validation project deliverables early. During execution of large projects, again in C&Q, project metrics are developed by project controls teams, which are different to project management. In successful projects, we are seeing project controls and validation form digital partnerships to find common ground with earned value analysis. Industry standard for large capital projects sees C&Q as a cost of 5%–10% of direct project costs, which are ultimately derived from a cost-per-protocol calculation. Proper benchmarking and earned value analysis best practices are driving these costs lower, closer to the range of 4%–6%, which is a significant cost savings in a €1 billion facility build.

A new frontier in digital validation will emerge when digital validation evolves from a protocol-centric approach to a data-centric approach for validating the same work. If the industry adopts this approach, we will see the tools of digital validation, data lakes, real-time dashboard reporting, and generative AI come together in novel ways. Imagine a real-time dashboard showing an instantaneous snapshot of a validated state of any production system or critical utility. Imagine an integration of digital systems that allows raw data (perhaps from a quality control laboratory system) to be pushed into protocol test cases. Imagine a library of user requirements, system classifications, system risk assessments, and protocol test cases organized by equipment type. The day may come when, as an industry, we stop duplicating critical engineering life cycle documents and manage these deliverables responsibly to generate validation protocol content that is fit-for-purpose every time. Everything mentioned here as a possibility is the promise of data-centric validation. Coexisting with this promise is another promise—that technology will continue to allow us to always do more, better, faster, and with less.

Conclusion

DVTs have proven to be a critical enabler for large CapEx projects, delivering measurable improvements in speed, compliance, and cost efficiency. By replacing paper-based workflows with integrated digital systems, organizations achieve faster C&Q, enhanced audit readiness, and real-time visibility across project life cycles.