Life sciences companies are under increasing pressure to use advanced manufacturing processes and sciences to ensure that manufactured drugs and devices meet patient safety, product quality, and data integrity compliance requirements. Additionally, social and political pressures require them to produce affordable medicines and therapies for a broader section of patients across the economic ladder. To achieve these patient-focused outcomes, life sciences manufacturers design quality into their operations and systems and validate them to ensure that these systems and processes function as designed.
This blog post examines the factors that cause validation projects to fail and how to address those factors proactively to pre-empt failures and avoid significant cost increases.
What is Validation?
Validation is the documented evidence of testing to verify that computerized systems, equipment, and processes consistently perform as designed and are “fit for use.” Since validated systems must be maintained in a validated state, any changes to the system must be revalidated. Thus validation is a recurring cost and, if not performed optimally, could significantly increase the cost of goods sold (COGS).
Many validation projects invariably run over budget and fail to meet schedules. This conundrum often results in management eyeing validation costs suspiciously. Under cost containment pressures from management, there is a tendency to cut corners, resulting in increased compliance risks.
Some of the most common regulatory observations and citations involving validation include:
Failure to validate a system used for regulatory purposes
Absence of written procedures for validation
Absent or inadequate objective evidence of validation
Validation standard operating procedures (SOPs) are not followed
Validation is not risk-based
6 Factors Contributing to Validation Project Failure
Validation project failure can be attributed to the following factors:
#1: Unclear project objectives and methodologies
The project sponsor needs to define the validation project objectives clearly. The project manager should develop a clear and concise project execution plan (PEP) at the start of the project and train every project team member on the PEP. Clear, unambiguous, and concise system and user requirements are also critical to a successful project. A robust validation project plan (VPP) is the responsibility of the validation lead; it should outline the scope of validation activities, the testing approach, the testing team, their duties, and the acceptance criteria. Inadequate planning in the areas stated above is the foundation for the failure of a validation project.
#2: Failure to engage all stakeholders consistently
Successful validation projects result from the continued engagement of stakeholders, including the project sponsor; business unit executives; quality personnel; and IT, QC, and engineering team members. Consistent engagement ensures continuous adjustment and alignment to meet challenges from changing situations like scope creep and human error. Having a clear set of defined goals and objectives that is regularly reviewed throughout the project's duration is a recommended best practice.
#3: Absence of proactive project risk management
This is the most neglected aspect of project management. During project setup and team formation, the teams must proactively identify, analyze, and mitigate project risk to scope, schedule, and budget. Doing this upfront will prevent project risks from being addressed reactively — and prevent management from assuming the project team has lost control of the project. Developing and publishing a project risk management plan to educate the entire project team on the risks is wise.
#4: Untrained or poorly trained validation team members
Validation is a business-centric activity wherein business processes consisting of a sequence of activities are used to derive an outcome, e.g., a validated system. Outcomes can be successfully achieved if we focus on the associated elements individually — i.e., people, teams, and leadership.
Training people on the principles and methods of validation, along with the related regulations that validation is required to satisfy, is critical. It is also critical to explain why they are required to do what they're required to do, along with the impact on compliance if they fail to do it.
Training team members on the validation SOPs, including change management, is also necessary to avoid rework due to errors. Provision should also be made to establish an onboarding training program for new project members who join the team during the project. Many risks related to people factors could be eliminated through digital validation or automation of the validation process, as the industry refers to it.
The ValGenesis validation lifecycle management system (VLMS) gives project managers tremendous control over the validation process, allowing them to digitally manage validation projects and the team members assigned to them. The system's validation projects module enables users to easily manage complex validation projects with required quality gate checks and task dependencies, resulting in fewer errors and improved compliance and consistency.
#5: Inability to track project status in real time
Executive management often complains that they do not have real-time visibility into the current status of all projects. Usually, they are not made aware of critical issues until the impact on costs, timelines, and scope is significant or irreversible. Since management is the final defense against project failure, they must receive this visibility in real time, as in a dashboard format. ValGenesis' real-time reporting capabilities empower users to locate bottlenecks and resolve issues with any project or process as they arise — before they are likely to cause downstream trouble. Users can also drill down into granular details from dynamic dashboard graphs.
#6: Communication gaps
Real-time visibility into a project's status is also realized through holding recurring meetings of project team members; ensuring regular attendance of all stakeholders at these meetings; recording and releasing meeting minutes promptly; publishing a RACI (responsibility, accountability, consult, inform) chart to clarify roles and responsibilities; identifying the critical path in real time and assigning resources to move those activities out from the critical path.
Due to the complexity of project management, any validation project you undertake will likely have issues. However, knowing the factors that lead to project failure and the best practices for tackling them can increase the probability of success with your next validation project. One of the biggest benefits of digitization is that it enables validation to shift from a retrospective process to one that's more proactive and prescriptive. While every company is unique, the ROI data shows that digital validation is a giant leap forward in efficiency; it can reduce the time required to complete validation projects by 50% or more.
Many validation projects go over budget or fall behind schedule. Avoid these 6 common pitfalls to ensure your next project is a success.
Chinmoy Roy is a biopharmaceutical consultant with over 38 years of experience in CSV, Data Integrity, 21 CFR Part 11, Annex 11 and manufacturing process automation. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G) and is a Senior Industry consultant for Valgenesis Inc.. He has worked for and consulted with several companies to include Genentech, Roche, Bayer, Novartis, Gilead etc. He travels the world to train industry personnel in the areas of his subject matter expertise as well as to conduct data integrity audits. Chinmoy has a bachelor’s degree in Electrical Engineering and a Master’s degree in Computer Science. He lives in the San Francisco bay area.