Archiving

Archiving is the process of protecting records from the ability to be further altered or deleted and storing these records under the control of dedicated data management personnel throughout the required records retention period. Archiving is a formal process of taking a record off-line it to a different location disabling it from any further changes.

Requirements for Computerized Systems Validation

Requirements for Computerized Systems Validation are presented in the following documents:
- The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 11. Computerised Systems. Rev. January 2011.
- CFR Part 11 - Electronic Records; Electronic Signatures
- 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

IQ, OQ and PQ

Installation qualification or installation verification testing
Documented verification that a system is installed according to written specifications for design and configuration.

IQ is the first phase of system testing is installation qualification (IQ), also referred to as installation verification testing. IQ should provide documented evidence that the computerized system, including software and associated hardware, is installed and configured in the intended system testing and production environments according to written specifications.

The IQ will verify, for example, that the computer hardware on which the software application is installed has the proper firmware and operating system; that all components are present and in the proper condition; and that each component is installed per the manufacturer or developer instructions.

Audit trail

Audit trail. The audit trail is a form of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action.

Configuration management

Configuration management. A discipline applying technical and administrative direction and surveillance to identify and document the functional and physical characteristics of a configuration item, control changes to those characteristics, record and report change processing and implementation status and verifying compliance with specified requirements.