The GAMP Good Practice Guide on the Validation of Laboratory Computerized Systems is one such guide that was published in (12). GAMP Good Practice Guide: Page 3. Validation of Laboratory Computerized Systems. Table of Contents. 1 Laboratory Computerized System Categorization. The GAMP Good Practice Guide: Validation of Laboratory Computerized Systems is targeted to laboratory, quality, and computer validation.

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Figure 2 shows one approach to an integrated approach by considering the equipment operational requirements at both the modular and holistic levels and valifation software functions required; both of which are based on the way of working in a specific laboratory.

ISPE Releases New GAMP® Good Practice Guide On Validation Of Laboratory Computerized Systems

From no data generated to methods, electronic records and post-acquisition processing results. According to the main GAMP Guide all these items of equipment would be classified as Category 2 and “qualified” as fit for intended use. Section 10 notes that for testing or verifying the operation of the PQ against user requirements, the following are usually performed: These simple principles are easy to grasp and allow any laboratory full flexibility to be made of the risk-based approaches to regulatory compliance.

Conformance to specification is achieved according to the individual instrument’s SOP. For most computerized chromatographs and CDS in a postPart 11 world, you will need to add user types and users to the system that will need to be documented for regulatory reasons, for example, authorized users and access levels required by both predicate rules and 21 CFR Integrated Approach to Computer Validation AND Instrument Qualification What we really need for any regulated laboratory is an integrated approach to the twin problems of instrument qualification and computer validation.

There needs to be a single, unified approach to computerized system validation throughout an organization at a high level that acknowledges that there will be differences in approach as one gets closer to the individual quality systems, for example, GMP, GLP etc. This will be a two-part discussion of the guide and where we should go to cover adequately both equipment qualification and validation of chromatography-based laboratory systems.


Equipment used in the manufacture, processing, packing or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

GAMP Good Practice Guide: Validation of Laboratory Computerized Systems – Google Books

The three instrument groups are described along with suggested testing approaches to be conducted for each. Verification of userSOPs Capacitytesting as required Processes between input and output Testing of the system’s back-up and restore as required Security Actual application of the system in the production environment e.

You can’t operate practife equipment without the system and vice-versa.

Commercially available software that has been qualified does not require the pracctice level of testing. The vast majority of equipment and systems in our laboratories are similar to this, but consider the question: How good are the chances for the potential mistake to be discovered in time? 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.

The comparison of the GAMP Guide and the Laboratory GPG software classifications are shown in Figure 3 on the co,puterized side of the diagram and the arrows in the middle indicate how the two classification systems are mapped and are compared with prctice other.

These events are held in Copenhagen from September. In devising this classification system, the GPG proposes to include balances, pH meters, centrifuges and glass washers as “laboratory computerized systems”. Don’t look for simplicity in certain sections of this guide as it’s not there. Instead of five categories of software, we now have seven Categories A to G.

As you can see, the order of some of the chapters is a little strange. Of interest, the inside page of the GPG states that if og manage their laboratory systems with the principles in the guide there is no guarantee that they will pass an inspection — therefore caveat emptor!


There are alternative and simpler risk analysis approaches that can be used for the commercial off-the-shelf and configurable COTS software applications used throughout laboratories.

The publication offers guidance for addressing strategic and tactical computer system validation issues such as: Here, there needs to be a specification for the macro name plus version numberthe calculation or the programming or recording of the macro. Therefore, why should a risk analysis methodology that is very effective for new designs and processes be dumped or foisted systtems laboratories using mainly commercial systems?

ISPE Releases New GAMP® Good Practice Guide On Validation Of Laboratory Computerized Systems

The new Guide describes laboratory computer systems subject to good manufacturing practice GMPgood laboratory practice GLPor good clinical practice GCPand the key elements involved in a laborqtory life cycle from initiation to retirement. Examples of instruments in this group are balance, IR spectrometers, guids, vacuum ovens and thermometers. If you are not — then you have not understood the problem!

Validation of Laboratory Computerized Systems is targeted to laboratory, quality, and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life science industries.

To do otherwise is sheer stupidity.

By using our services, you agree that we use cookies. Software Support for M Commercially available instruments and systems have already been tested by the vendors which can be verified by audits.

For example, we use the same qualification terminology IQ, OQ and PQ for both instrument qualification and computer system validation but they mean different things. Do we have clear and agreed definitions of “laboratory equipment” and “laboratory system”?

Conformance to user requirements is highly method specific according to the guide. The equipment qualification requirements for traceable reference standards can also be devised for input into the URS. Only then will you be able to assess the risk for laboratpry system based on the intended functions of the system.

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