Overcome Validation Challenges through Proper Planning

How many times have you heard the expression “He who fails to plan, plans to fail”? Probably more than you can count since it’s attributed to several prominent individuals. Let’s face it, if we don’t know where we are going, then how will we know when we have arrived? The same concept applies to Computer System Validation.  What happens when you fail to have a proper validation master plan? Below are some likely outcomes:

1. 80/20 rule comes into play: A poor plan means that 80% of the effort you are putting into the project may only yield a 20% valuable outcome.
2. Spending too much time deciding what to do, so your CSV may take longer than necessary
3. The tasks are becoming redundant, which may increase costs and time.
4. You have a poor foundation which may cause your project to collapse
5. Non-ideal resources are assigned to the project, which may reduce quality and elongate the project timeline

Validation Planning Challenges:

Now that you have seen what can happen when you fail to plan properly, what challenges await when you begin the planning process? Let’s take it from the approach of questions that should be asked and answered at the start of a project:

1. Scope
   1. How long will this take?
   2. How much will it cost?
   3. Why do we have to go through this process?
2. Testing (Most critical aspect of validation)
   1. We’ve played with it and we know how it works, so do we need to test it?
   2. Everyone in the industry is using it; does it need to be tested?
   3. What functionality needs to be tested?
   4. Can we just use the vendor testing?
3. Resources
   1. Do we have personnel trained in the system?
   2. How can we schedule instrument interfacing testing without impacting day-to-day lab processes?
   3. Is getting the system validated a priority right now?
   4. Do we need to outsource the validation or augment our CSV staff?
   5. When and how long will project team members be needed?
   6. Do we have a plan if we lose team members to other priorities?

In addition to the challenges that face you in the planning process, there are challenges to keep in mind that can develop during the project:

1. The Unknown (your biggest challenge)
   1. We did not know the system could do that, can we add that now? (scope creep)
   2. What’s the backup plan if the testing environment is down for maintenance?
   3. The FDA is here for an inspection and key team members are tied up, now what?

Validation Plans:

So now that you know what questions to ask, what type of plan is needed for your project? The type of plan depends on the size of your business and the approach you want to take for the validation project. The four main levels of plans are:

1. Multiple Sites – Validation Policy
2. Single Site – Validation Master Plan
3. Specific Department/Business Area – Validation Master Plan
4. System – Validation Project Plan

A Validation Policy is a one page document that describes the company’s policy and approach to computer system validation.  A Validation Master Plan should exist for each site (and could include the Validation Policy for single site companies) as well as the following: scope, references and supporting documentation, organizational structure, summary of facilities, lab setup, systems, high level schedule, and change control policy for validation changes.  A Validation Project Plan is specific to a system and should link to the Validation Master Plan.

Once you’ve developed the right set of plans to govern your validation project, you want to make sure you start the project as soon as possible. In addition, consider having a kick off meeting so you can properly begin the communication of your plan. As soon as everything is in place, you have properly planned, and the project has begun, you will notice that your personnel are motivated because they have a sense of direction, which will in turn increase efficiency and minimize risks.

Conclusion

Remember, “He who fails to plan, plans to fail.” It is clear that there is no substitute for proper planning when you are undertaking a computer system validation project. Once you have defined your scope, identified your resources, and established what testing is needed and how you will tackle the unknown, your computer system validation can be properly accomplished and streamlined.

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What challenges have you faced during validation planning? What did you learn from those challenges?