QUALITY AND VERIFICATION.

METRICS and QUALIFICATION.

Equipment Validation is about more than just complying with regulatory expectations requires an appropriate life cycle, effective program and project management and a thorough understanding of both the business processes being supported and the associated regulations GLP - GCP - GMP - GDP.

System Qualification (CSV) can be very simple and straight forward, and then again at times, it can be complex and difficult. A great deal depends on the contents of the company Practices and Procedures Manual, or failing this being in place, the VMP and VP, where procedures for the writers and executers to follow, should be detailed. It can be almost impossible to split such systems into computer and equipment; therefore the system must be qualified, taking note of the specifics of each and the overall functionality achieved by the system. While recognizing that the diversity of software, as defined in GAMP 4 & 5, is vast, you have to remember that the classic operating systems (same as, or similar to XP, because of the vast number in service, are taken as standard, and do not require to be qualified. Therefore when you come to application programs, that run on these standard operating system programs, your system qualification effort does not have to include the standard operation program, just the application program. For example, the application program for most Programmable Logic Computer (PLC's) is used to give equipment functionality, making a system qualification in this instance, quite a straight forward and simple task.

Gamp Class

Category

Validation Scope

1

Operating

Systems

Record Version

2

Measuring Devices bespoke software.

Record Configuration & calibration

3

Configurable

Packages

Review supplier & validate functionality and any bespoke code.

4

Large Configurable Systems

Audit supplier, validate system functionality and review code IAW full life cycle requirements.

5

Systems Specifically written for Owner.

Audit supplier, validate all code IAW full life-cycle requirements.

The EU GMP Annex 11 on equipment qualification requires that there should be "adequate alternative arrangements for systems that need to be operated in the event of a breakdown". These arrangements should provide for alternative workaround procedures to be implemented and followed, to replace the absent system functionality and allow safe continuation of business during the failure.
Regulators, and internal / external auditors, require evidence that Business Continuity Plans have been created and rehearsed, including records that the alternative processes have been suitably documented and personnel adequately trained. Companies should be able to demonstrate that they can ensure that critical services and processes can continue, that the restoration of workforce, facilities and equipment occurs in a timely fashion and that there is a timely resumption of essential business functions.

VALIDATION


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