Chapter 10. Certify the System





This chapter looks at the second to last step in the validation process, certifying the system.

The objective of the certification is to verify that all validation deliverables have met the acceptance criteria that were described in the Validation Protocol.


Validation Report

The System Validation Team should produce a Validation Report that describes:

·         what was done

·         the results obtained

·         any special considerations regarding the use of the system that were identified during the validation process

·         whether the procedure as described in the Validation Protocol was followed, and if not followed then what was the deviation and why

·         whether or not the acceptance criteria were met

·         the documentation that was generated

·         the location of the documentation generated

·         the retention period for the documentation

Independent experts may review the results of specific validation activities and the summary report may incorporate their findings.


Document Retention

Documentation associated with the validation must be retained at least for the lifetime of that system.

Special consideration should be given to regulatory requirements for document retention, especially for computer systems holding information, which may pertain to patient safety.


Acceptance Criteria

Detailed acceptance criteria will have been defined for the individual qualification activities, whilst high-level acceptance criteria will have been defined in the Validation Protocol for the validation as a whole.

It should be noted that in some instances not all of the acceptance criteria for a validation will be met. If this is the case, then the Validation Committee are responsible for determining whether or not the system can be certified for use.

The Validation Committee may certify the system for use provided:

·         that there is an action plan for resolution of the issues

·         appropriate manual procedures are in place to supplement the computer system if necessary

Detailed guidance cannot be provided on this topic, as it will always be a matter of professional judgement of the personnel involved.


Certification review

The authorized parties, as identified in the Validation Protocol, review the Validation Report to confirm that the procedures were followed and that all acceptance criteria were met.

Approval for use of a computer system once the validation is complete is the responsibility of site or departmental management.

If the Validation Report is accepted, then the reviewers certify the system as validated by signing either the Validation Report or a certification form.

If the implementation date for the system is different from the certification date, then this must be indicated.


Existing system

The process for certifying an existing system is the same as for a new system.


Introduction to CSV Validation Responsibilities Before You Start Validation The Process Establish Teams(s) Determine Activities
Write the Protocol System Development Details Perform Qualification Activities Develop &  Review  Procedures Certify the System Review Periodically