Upon completion of proper validation and the launch of production, the object of validation / qualification moves into the state of operation and maintenance.
This means that from that moment one should take care that none of the activities performed should cause the loss of the validated state.
What is also connected with the operation and maintenance state is also withdrawal from use.
The stage of withdrawal from use is also incorporated into the validation life cycle and requires taking appropriate action.
We develop relevant procedures and instructions
We conduct training and implementations as per the instructions mentioned above
We take an active part in incident management and change control processes (we review and assess changes, supervise scheduled actions, perform validation activities – for example, preparation of documentation and testing)
We perform periodic inspections
We do revalidation and re-qualification (to the extent identified in the risk assessment)
eLife Sciences is a team of experts with unique experience in compliance, validation and quality assurance (QA). We provide services to companies in regulated industries with a special focus on life science.
