Sunday, November 9, 2008

Computerised System Validation Part 3

To view Computerised System Validation Part 1 click here
To view Computerised System Validation Part 2 click here
Site/Function Activities
1. Validation Master Plans
Computerised systems requiring validation should be identified as such in site/function validation master plans (VMP). Plans should be produced in association with system registers, identifying validation requirements for both new and legacy computerised systems.
2. System Register
System registers, providing an inventory of computerised systems should be created and maintained for each site or company. Advice for centrally developed/supported systems can be found in the forthcomming posts.
Note: Sub-systems and systems components should not be listed in the system register. Each register should contain, as a minimum, the following information for each system listed:
• Name (by which the system is known and commonly referred to).
• Unique reference/acronym (for traceability).
• System description (phrase/sentence describing what the system does).
• System type (indicate, e.g. whether this is a local system, a system that is supported by another site, or a corporate system).
• GxP/regulated determination (whether it is GxP/regulated system) (Yes/No).
• Validation status (whether it meets current computer validation requirements) (validated, not validated, validation in progress, validation not required).
• Electronic records and electronic signatures (ERES) status
• Regulatory submissions use (whether used for regulatory purposes other than GxP) (Yes/No).
• Reference to validation support and documentation index/archive location.
The basic attribute list is not exhaustive and may be extended as appropriate
to meet specific site needs. The system register should cover all manufacturing, packaging and distribution computerised systems. Some sites may wish to include names of contacts (e.g. developer, system support, user and validation) that could present information concerning the computerised system during an inspection. Sites may wish to consider including a
document archive reference to facilitate faster document retrieval.

Following is the Approach To some of the System Register Contents

Type of System
Laboratory System
System Register Guidance
One entry per system.
A separate entry is required for each physical system of the same type.
pH Meter, Ultrasonic Bath, Mass Balance, HPLC, FTIR, Chromatography Data System,Robotic Systems
Type of System
Process Control
System Register Guidance
One entry per system.A separate entry is required for each physical system of the same type.
Intelligent/Smart Instruments, PLCs, SCADA System, Distributed Control Systems, Expert Control Systems,
Type of System
Desktop (User) Applications
System Register Guidance
One entry per GxP spreadsheet/database applications.
Spreadsheet applications, Database applications, including Lotus Notes.
Type of System
IT System
System Register Guidance
One entry per production system instance.
Care must be taken to ensure sites understand which multi-site systems they use.

Guidance on which systems require registration on the system register is given above. The system register may consist of a number of lists so long as collectively they cover all computerised systems. Written dispensation may be given to individual functions/departments
excluding them from the scope of the system register where they have no
computerised systems. In some situations there may be large numbers of computer applications that do not require validation and the practicalities and value of listing them on the
system register might be questioned. For example, spreadsheet applications are used widely but typically only a small fraction is used in a GxP context. Guidance on which systems require registration and how to record them on the system register is provided in the section of this guideline dealing with desktop applications.
Standard COTS packages should not be registered separately from their application (e.g. Excel, MS Project, MS Word, MS Access) as their use will be captured as part of the application using them. Operating systems such as Unix, NT, and Oracle should not be registered.

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