Expand Your Quality Ecosystem: Unifying Validation Workflows With QMS
Even though validation is driven by quality events, such as deviations, change control, and corrective and preventive actions (CAPAs), validation remains siloed from quality in most biopharma companies. Legacy validation solutions were often implemented independently, site by site. As a result, there is a lack of integration with quality management systems (QMS) for quality event management, and IT systems for change control.
Validation and quality teams are forced to make cumbersome manual updates to compensate for these shortcomings. Given the increasing number of validation projects, validation managers must find ways to deliver quickly and accurately without additional resources. Manual updates create bottlenecks and are often the “broken link” in the value chain, preventing validation managers from optimizing the process. As they lack visibility, they may be unable to confirm or demonstrate to auditors that the procedure is being followed correctly.
Quality and validation systems speaking different languages
Validation management and quality management typically have distinct focus areas: validation teams ensure that processes, systems, and equipment perform as intended and meet regulatory requirements, while quality teams oversee compliance, standards, and consistency across all processes.
Quality and validation management processes are often not integrated and lack clear governance, which increases the risk of the procedure not being followed correctly. Data sharing is usually limited and silos mean that it’s unclear which team ‘owns’ each data point. Lacking access to centralized data, validation and quality teams routinely wait for responses, duplicate their work, or transcribe data manually from one system to another, resulting in delays and errors. This makes robust reporting challenging: data from each function is reported in a silo, rather than holistically for organization-wide view and use.
Change actions must be reflected in all systems but are completed manually because the technology environment is disconnected. Afterward, quality teams need to show evidence that they have completed the validation activities required by the change control but don’t have visibility of the validation process, which might undermine audit readiness.
Many companies complete periodic reviews on a cadence (typically every one to two years). For each system they evaluate, they will need to sift through a large volume of information and go through many back-and-forth manual reconciliations, just to understand the impact of change actions.
Accelerating time to release
Multiple disconnected systems are the source of inefficiency, while duplicative efforts and maintenance and training costs increase the total cost of ownership — and that’s before factoring in the commercial impact of integration.
Real-time collaboration between validation management and quality would shorten validation cycle times and reduce costs by:
- Reducing bottlenecks: Unifying validation and quality workflows means test discrepancies can be linked to deviations, change impacts can be traced without manual reconciliation, and data integrity can be improved.
- Improve efficiency. Automation reduces errors and enables real-time collaboration and activity tracking across team members, helping to enhance team capacity.
- Better compliance. Eliminating manual work reduces the risk of data errors and duplication. Controls within the application also support the organization in managing compliance across the life cycle, while reporting helps proactively identify potential improvements early.
The result is that companies that bring together validation and quality under one umbrella significantly reduce cycle times and are more confident that their system is audit-ready. Resilience’s Director of Quality Applications, Tamara Redondo, explains: “At Resilience, we’re able to release so quickly because we trust in Veeva to do the compliance work for us and ensure that we’ll always be confident in our audits.”
Unifying with quality
Greater connectivity between validation and quality is one effective way to generate business value. When quality and validation teams share a unified workflow and data, the wider business gains real-time visibility into key metrics (for example, test discrepancies and their impact), helping to improve risk management.
Working on the same platform allows teams to align expectations and ensures accountability. All functions have the full picture and can see who is responsible for what and by when. Validation teams can then highlight and prioritize actions for quality and vice versa, and feel more confident that they will be completed on time. With a full view of the end-to-end validation process, companies can accelerate their time to market.
A seamless and streamlined workflow also helps to deal with discrepancies efficiently. For example, if validation teams are running a test and encounter a complex issue requiring investigation, they will need to secure the quality team’s buy-in should they wish to make a change. This becomes much easier when these teams have a unified workflow: quality can see the full impact of the discrepancy raised by validation, including the breadcrumb trail of previous information, and agree to any proposed actions.
Greater value than the sum of its parts
Validation and quality have optimized their ways of working to fulfill their goals and responsibilities as individual functions. This has led to siloed data and processes, and delayed batch release. It is now time to bring the functions together for enhanced business value.
Once quality and validation systems speak a common language and share data, your organization will have the foundation for a unified validation workflow with QMS. This would accelerate project cycles and improve audit readiness and data integrity while meeting the ambition of completing more validation projects with constrained resources.
Learn how Vault Validation Management can streamline your quality and validation teams’ workflows.