GAMP GOOD PRACTICE GUIDE VALIDATION OF LABORATORY COMPUTERIZED SYSTEMS PDF

Zulrajas From conversion of analogue to digital signals to post-acquisition processing. Using this approach, I believe that you will be performing over complex and over detailed risk assessments forever for commercial systems that constitute the majority of laboratory systems. Group C instruments cover a wide spectrum of complexity and risk, and may have very diverse requirements. There are alternative and simpler risk analysis approaches vuide can be used for the commercial off-the-shelf and configurable COTS software applications used throughout laboratories. The guide covers the initial qualification activities for analytical instruments but there is very little on the validation compuherized the software that controls the instrument.

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This additional guide takes the fact into account that there are very different devices in a typical laboratory and that it is thus neither feasible nor cost-conscious to fix the same procedure for the validation of the systems of all present lab devices. The recommendations given in this guide are meant to help the user in the pharmaceutical industry to develop a rationale for a graded scope of the validation of computerised systems in the lab.

One important tool for establishing the scope of validation are risk management considerations. The following considerations have to be taken into account during risk analysis: Will a potential mistake have grave consequences? How likely is the occurrence of this mistake? How good are the chances for the potential mistake to be discovered in time? However, the central point of this new guideline is the new classification into seven categories A through G.

Especially for the laboratory, the former five GAMP categories have been subdivided further. Category A represents systems whose software cannot be configured or modified ovens and centrifuges are mentioned as examples , and category G stands for complex systems example: self-programmed software or modified spreadsheets.

The practical implementation still has to show whether this further subdivision is really helpful. The authors themselves state that e. As to the wording, the authors of the new GAMP Guide have again chosen the term "validation" instead of "qualification", since "validation" is considered to be the more comprehensive and therefore more suitable term. These events are held in Copenhagen from September.

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