Life Sciences companies are under increasing pressure to use advanced manufacturing processes and sciences to ensure that manufactured drugs meet compliance requirements of patient safety, product quality and data integrity. Additionally, social and political pressures require them to produce drugs that are affordable to a broader section of patients across the economic ladder. To achieve these patient-focused outcomes, they are not only designing quality into their operations and systems, but they are also validating them to ensure that these systems and processes function as designed. This article addresses why validation projects fail and result in signification cost increases.
What is Validation
Validation is the documented evidence of testing to verify that computerized systems and processes consistently perform as designed and is “fit for use”. Since validated systems must be maintained in a validated state, any changes to validated systems are required to be re-validated. Thus validation is a recurring cost and if not performed in an optimal manner, could significantly increase the Cost of Goods (COG).
Many validation projects invariably overrun budgets 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 which results in an increased compliance risks. This article provides factors that cause validation projects to fail and how to proactively address those factors to pre-emp failures. Some of the common observations and citations on validation by regulatory auditors include:
- Failure to validate a system used for regulatory purpose
- Absence of written procedures for validation
- Absent or inadequate objective evidence of validation
- Validation SOPs are not followed
- Validation is not risk based
Factors contributing to validation failure
Validation project failure can be attributed to the following factors:
- Unclear project objectives and methodologies
- Failure to engage all stakeholders consistently
- Absence of proactive project risk management
- Untrained or poorly trained validation team members
- Lack of project status in real time
- Gaps in communication
Unclear project objectives and methodologies
It is important for the project sponsor to clearly define the validation project objectives. 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. A clear, unambiguous, validatable and concise System Requirements and User Requirements developed at project start by the appropriate stakeholders is also the key to a successful project. A robust Validation Project Plan (VPP) is the responsibility of the Validation lead and it should outline the scope of validation activities, the testing approach, the testing team and their responsibilities and the acceptance criteria. Failure in planning in areas stated above is the foundation for the failure of a Validation project.
Failure to engage all stakeholders consistently
Successful projects result from the continued engagement of a set of stakeholders consisting of the project sponsor, business unit executives, quality personnel, members from the IT, QC laboratory and engineering groups etc. It ensures continuous adjustment and alignment to meet challenges arising from changing situations such as scope changes, human errors etc. A clear set of defined goals and objectives, reviewed throughout the term of the project is a recommended best practice.
Absence of proactive project risk management
This is the most neglected aspect of project management. During project setup and team formation, the teams fail to proactively identify, analyze and mitigate project risk to scope, schedule and budget. Doing so up front will prevent project risks to be addressed reactively which provides management the optics of the project team as having lost control of the project. It is prudent to develop and publish a Project Risk Management Plan and educate the entire project team on the risks.
Untrained or poorly trained validation team members
Validation is a business centric activity wherein a business process consisting of a sequence of activities are used to derive an outcome e.g. a validated system. However, outcomes can be successfully achieved if we individually focus our attention to the associated elements – such as people, team and leadership. Training people on the principles and methods of validation along with the associated regulations that validation is required to satisfy is critical. Explaining to them why they are required to do what they are required to do along with the impact to compliance if they fail to do so is also very critical. Training them on the Validation SOPs to include Change Management etc. is also necessary, so as to avoid rework due to error. Provision should also made to establish a project onboarding training program for new project members joining the team during the course of the project. Many of these risks due to people factors may be eliminated through use of paperless validation or as the industry refers to as automation of the validation process.
Lack of project status in real time
Executive management often complain that they do not have real time visibility into the current status of all projects. Unfortunately, they are made aware of critical issues when the impact on costs, timelines and scope are significant or irreversible. Since they are the final defense against project failure, it is critical that they be presented this visibility in real time in a concise and clear manner such as in a dashboard format.
Gaps in communication
Real time visibility into a project status is also realized through regular standing meetings of project team members, release of meeting minutes in a timely manner so that issues identified are satisfactorily addressed and reported out during the next meeting, ensuring regular attendance of all stakeholder at these meetings, publishing a RACI (Responsibility, Accountability, Consult, Inform) chart, identifying critical path in real time and assigning resources to move those activities out from the critical path etc.
Business expediency requires that validation of systems and processes is a priority of executive management and that the validation objectives are realized efficiently through appropriate planning, risk management, preventing scope creep through planning and requirements definition, an agreed to acceptance criteria with the project stakeholders and ensuring that executive management including the project sponsor has continuous visibility into project status in real time.
About the Author
Senior Industry Consultant
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.