Maintenance of the validated state

Maintenance of the validated state

Maintenance of the validated state is no less important than the validation itself. 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.

Properly implemented “Maintenance of the validated state” allows to save time and costs, when managing existing and validated system and/or equipment.

The most common causes of the loss
of the validated state

  • breakdowns and repairs
  • change implementation
  • amendments to laws and standards

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.

The most frequent processes being part of the maintenance of the validated state include:

  • incident management
  • change management
  • periodic inspections (APR, regarding equipment, installations, etc.)
  • revalidation and re-qualification
  • withdrawal

We perform the following, among other things, as part of the maintenance of the validated state:

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)

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