Causes of Validation Problems

The business pressures of a consolidating life sciences industry and reduced margins pressure business leaders to demand ever more aggressive IT system delivery schedules, often absent well considered definition and assessment of the actual project scope, requirements, resources and regulatory impact.

As a result, hasty business and IT project planning coupled with lack of time for consultation across disciplines sometimes causes gross underestimation of the IT and validation project plan milestones.

While the most obvious symptoms of a problem validation project are failures occurring in the execution of test protocols, there are many other symptoms that validation practitioners are seeing as early warning indicators of negative consequences for validation projects. The negative project consequences we at USDM Life Sciences are endeavoring to forestall include:

• IT system deployment delays due to failures in dry run or formal validation testing requiring substantial remediation
• Validation efforts which fail to unearth significant system flaws which emerge upon deployment to production
• Compliance gaps uncovered in audits of production systems due to poorly scoped or executed UAT or validation testing
• Properly functioning validated systems put into production and later discovered to have corrupted data due to overlooked data migration or interface issues
• Deployed validated systems which operate to requirements but are ineffective in production due to overlooked change management issues

The Visible Root Causes of Validation Problems:

While some of the most insidious causes of validation project problems are hidden, it must be acknowledged there are also those that are not hidden and squarely sitting in the QA or Validation group domains. Those include among others:

• Poorly defined or conflicting standards for validation process and deliverables in terms of content, format or risk assessment and reviews
• Out-of-date or rigid validation processes that do not have well-defined risk based procedures to scale a project’s focus, resulting in “boil the ocean” projects
• Validation methodologies that do not address business SOP development early enough in the validation life cycle, or do not meet accepted industry best practice standards
• Overburdened QA and validation groups that cannot be responsive to business needs and become obstacles for business progress
• Lack of partnerships between QA and validation groups and IT and the business units
• Document Control and training procedures that are ill defined or do not meet best practice

The Hidden Root Causes of Validation Problems:

• Regulated IT Governance Missteps
• IT and Business Culture Issues
• Agile Methodology Applied Indiscriminately
• Confusing the UAT and Validation testing efforts
• Configuration and Test Environment Administration Issues
• Trivialization of Data Integrity Considerations
• Underestimating the impact of new architectures

With continued increases in IT system complexity, regulatory scrutiny and IT cost reduction pressures, the proportion of these occurrences are likely to increase unless new approaches to combined IT and compliance project planning based on informed best practices are adopted by the regulated industry.