Support Program for Maintaining Validation

A support program to maintain validation shonld be identified. It should include procedures for change control, maintenance and calibration, secnrity practices, contingency planning, operating procedures, training, performance monitoring, and periodic review. Operation and maintenance is discussed further in Chapter 12. 

An experienced validation practitioner can prodnce a Validation Plan for a computer system (usually 10 to 15 pages long) in abont 3 days. An example Vahdation Plan layout is illustrated in Appendix 6C. The structure of Validation Plans mnst be scaleable to fit the system or software being validated. For large projects, configuration management and fnnctional test planning may be split ont into separate documents. Validation Plans can also make nse of appendices for project milestones and resumes of project team members. 

The Validation Plan must be reviewed and approved before issue. They are regulatory documents specifying the quality and compliance controls nsed to manage the deployment of a compnter system. At a minimum, a Validation Plan shonld be signed and dated by the System Owner as well as by the Quality and Compliance representative. 

Validation Plans should be maintained to reflect changes in project activities. Specific revisions to plans should be considered when transitioning between major project phases  

Thereafter, Validation Plans should be updated or superseded by new plans when the architecture of the computer system changes from the original scope of validation there has been a significant change in how the computer system is used compared to the original vahdation there has been a change in operation and maintenance standards or when a revahdation exercise has been initiated. 

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Variations in temperature and humidity might be monitored over a period of time using a portable chart recorder as part of the PQ. Vulnerabilities to electrostatic discharge (ESD), vibration, and dust are more difficult to measure. All that may be possible in this context is to periodically review whether these have affected live operations in any way. If this is the case, it should be clearly stated and the causes followed up as part of the ongoing support program for maintaining validation. 

The report should also preview the validation file documentation, control procedures, and support programs that are vital to the ongoing validation program and must be used as the basis for maintaining the validation status of the computer system. At this time a review of the GMP risk assessment should be undertaken and included as a section in the validation report. 

There are no additional or reduced regulatory requirements for closing sites. Computer systems should be maintained in a validated state of compliance up until the very last day of their operational life. GxP records must be archived and stored for the required retention periods. Archived records should be readily retrievable to support critical quality operations like recall, customer complaints, and batch investigation. Computer systems should then be decommissioned, as discussed later in this chapter. Some computer systems may be disassembled and sent for installation at other sites as part of a program of drug product transfers. 

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