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To ensure that a system functions properly, the GAMP standard requires a traceability log that describes from URS to OQ which requirements have been conceived and implemented in which way. That is why it is important to pay close attention to the requirements of GAMP from the start of a project, so that documentation can be started on time.

Validation process

When validating systems, two things, documentation and the people involved must be taken into account. Before validation can be started, all systems must be tested by the supplier, and these tests must be signed and delivered by the supplier.

When these tests are done, all validation participants involved must make a clear document which tests will be done to make the validation successful. Once the validation protocol has been approved, a validation can be done. Only when all points in the validation have been signed, can the system be released for production.

Validation Protocol

A validation protocol can take over testing from a supplier, but it is often common for a signed system test to be used as a condition for performing a validation. The protocol is then supplemented with system requirements set in the User Requirements Specification (URS). These are often user requirements at system level. This can be for example:

  • Networks must be redundant
  • The system must save data for 1 year
  • An image change must take place within 3 seconds
  • Images must be viewable on a PC and via a web link
  • Hardware must be usable from 5 to 60 degrees Celsius

A test is often devised together with the supplier to validate the system. If these tests are included in the protocol, the intention is that they can be validated without annotation.

What does a validated system mean

After a system has been validated, nobody can change anything about the validated systems. Because the user has indicated with the validation that the system works as they want it at the time of validation, production can be started at that time. The user assumes responsibility for the correctness of the system at the time of validation and indicates by signing the validation report that the system is suitable for production in the current situation.

The moment something needs to be changed, the user must submit a change request. A change request can be made to the system with a change request. This CR is provided with a risk analysis and a validation plan for changes to the system. Once the changes have been implemented, the validation plan must be validated and production can resume.

iAUTOMATION solution

At iAUTOMATION we have done many projects with validation structures and therefore have a lot of experience with setting up projects so that validation is made easy. iAUTOMATION can support you in many ways, we have written 3 for you to provide an insight into what we can do for you.

GAMP documentation

All project documents are made suitable for validation according to the GAMP standard

Validation support

Based on existing documentation, iAUTOMATION advises which procedure must be followed during the validation procedure.

During validation, iAUTOMATION will support the validation team as an independent inspection party.

iAUTOMATION will prepare a validation report for the GAMP completion


Writing GAMP documentation

iAUTOMATION writes the documentation for the GAMP process with the help of the process owner. Consider the following documents:

  • URS
  • FDS
  • SDS / HDS
  • FAT / SAT procedure