Validation putting to the test

Do you have an own validation team in your company in place? That is great!

Next question:

What do you do to ensure that the validation processes and the related documentation are controlled accordingly? Do you and your team have an overview?

With the time the effort can increase. You will not realize it because you and your team have developed an operational blindness. Perhaps some colleagues complain about too many forms and documents to be filled out. Or they do not understand the validation processes any more. Or you simply realize that your colleagues need more and more guidance to fulfill the validation process correctly and completely. You choose to size up your validation team. And they write more standard operation procedures (SOPs) and process descriptions to detail the validation process more and more. Great! -> System overloaded!?

?You may notice, that audits by authorities or notified bodies will confirm that your validation processes fulfill all the regulation requirements. Because this additional effort and documentation in validation bring pluses. But at what price?

You miss the forest for the trees!

You do not see that?your processes to your computerized systems and their validation need to be?adapted.

But what should you do?

First you have to step out of your comfort zone of thinking that you have no issues regarding your validation at all.

That means you must establish mechanisms to perform periodic controls of your validation processes themselves. This can be managed e.g. by internal or external auditors which have the experience to see and define the?precise?borders for less regulatory?necessities?and the limits of too much interpretation of regulatory?requirements.

This is the first part of?CSVapt?that helps you recognize the regulating screws to act.

But what is the next step now?

You need people having the the experience and knowledge to identify the?measurements to conduct the correct and?tailormade?actions to bring back the validation processes to a healthy and realistic level. This person or team will implement those changes.

This is the second part of?CSVapt?that helps you to stay in the right shape with your validation processes and related documentation.

You like to learn more about?CSVapt?

Do not hesitate to contact us!