Where does Validation Fit?

Validation¹, which is essential to cGMP compliance, is part of a total quality program. It overlaps many related activities such as design, documentation, training, calibration, maintenance, etc. It overlaps many phases of a project from concept to completion.

It fits, to some degree, into all phases of development, manufacturing, packaging, storage and distribution. However, it is key to remember validation does not exist in a vacuum. It is a team exercise and an integral part of everyone’s job.

This is important to remember when you are out in the field - EVERYONE COUNTS, from the operators to the mechanics to the QA/QC folks, to the validation and engineering teams and all in between.

Understanding where validation fits is an integral step to understanding quality assurance and the many different aspects of compliance in the Life Sciences industry.

To some, it all might seem like a long, drawn-out process, but there’s a good reason for it. If you can ensure your equipment/systems or products perform consistently and meet industry requirements, the value of both the product and patient safety increases.

Along with this increased value comes a greater need to understand that the work we do matters, and that helping Life Science organizations ensure compliance and consistency with current regulations when carrying out commissioning, validation and qualification projects in a safe and efficient manner ultimately leads to saving lives.

¹ Validation is the documented act of demonstrating that a procedure, process, and activity will consistently produce results meeting predetermined acceptance criteria.