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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The equipment qualification requirements for traceable reference standards can also be devised for input into the URS.

New GAMP Good Practice Guide “Validation of Laboratory Computerized Systems” Published

How likely is the occurrence of this mistake? Tampa, Florida, USA Instead of five categories of software, we now have guidd Categories A to G. 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.

Summary Qualification of laboratory equipment and validation of computerized laboratory systems are going into two different directions that lack an integrated approach. You can’t operate the equipment without the system and vice-versa. Especially for the laboratory, the former five GAMP categories have been subdivided further. The scope of the guidance and proposed USP chapter is limited only oc commercial off-the-shelf analytical instrumentation and equipment.

Against this will be formal testing to ensure that the functionality works as specified. Sign up for our free newsletter I agree to the Terms and Privacy Statement. The argument for the SILC: In the words of Albert Einstein: However, on the bright side the dishwashers bit the dust long before the final version of this publication!

GAMP Good Practice Guide for Validation of Laboratory Computerized Systems_百度文库

This is shown in Figure 3 on the left-hand side. The following considerations have to be taken into account during risk analysis: The new publication joins ISPE’s extensive library of technical guides, developed in cooperation with global regulatory agencies and industry professionals. If you ptactice problems displaying the website, is maybe JavaScript disabled on your browser, or your browser does not support JavaScript!

One important tool for establishing the scope of validation are risk management considerations. ISPE provides a wide range of Member-driven educational programs and resources to pharmaceutical industry practitioners worldwide, and is the originator and owner of all GAMP programs. For example, gooe is the validation plan written so late in a life cycle or why is the chapter on training of personnel positioned after the validation report has been written?


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After the software has been installed and undergone the IQ and operational qualification OQ has been performed, then the software can be configured according to the configuration specification documents. Moreover, because laboratory systems — system impact table some systems can be classified in a number of laboratory categories there is a possibility that the impact of a system can be underestimated.

Over the past years I have not spoken in any great detail about guidance documents on computer validation for chromatographic systems and chromatography data systems CDS but concentrated on a specific topic from the regulations themselves. This must ensure that the laboratory is not separated from the organization or creates a profession of Lablish interpreters. Once the software functions have been understood, an application configuration specification can be written that will state what functions in the software will be used, turned on, turned off or modified.

Risk AssessmentMethodology OK, if you managed to get this far after reading Part 1, we now have the finishing touch — the risk assessment methodology.

The practical implementation still has to show whether this further subdivision is really helpful.

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

The great concept is the system implementation life cycle and a realistic at last! This is configurable commercial off-the-shelf software configurable COTS. Summary In today’s risk- based environment, computer validation and equipment should be getting easier, quicker and simpler. As with any performance appraisal system, let’s start with the good news first and work our way downhill afterwards.

Results and data storage: If you qualify the instrument you will usually need the software to undertake many of the qualification tests with an option to validate the software at the time.

The software used in some laboratory computerized systems may need to be configured — this is a term for either selecting an option in the software to alter its function within limits set by the vendor. These events are held in Copenhagen from September.

Section 10 notes that for testing or verifying the operation of the PQ against user requirements, the following are usually performed: Commercially available instruments and systems have already been tested by the vendors which can be verified by audits.


The proposed chapter uses the term “analytical instrument qualification” AIQ to describe the process of ensuring that an instrument is suitable for its intended application but the instrument is only a part of the whole computerized system.

The horror that some of you may be having now around the suggestion to validate a balance, pH meter or centrifuge is gooc about terminology used rather than the work that you would do. Information technology personnel supporting these systems, end users, software developers, and suppliers of laboratory computerized systems will also benefit.

The overall process flow for the risk assessment is lxboratory in Figure 1: This all adds up to scientific-based control of the system, the chromatograph and potentially also a method.

Like what you are reading? Will a potential mistake have grave consequences? Validation of Laboratory Computerized Systems. In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification.

The left-hand side shows the system practuce life cycle SDLC that is intended for more complex systems and the righthand side which shows the system implementation life cycle SILC for simpler systems. From no data generated to methods, electronic records and post-acquisition processing results.

Sign up for our free newsletter. Installation can be complex and prractice specialist skills e. Why this over complex pracrice was selected for laboratory systems is not discussed although I suspect that it is aimed at consistency throughout the GAMP series of publications. Strictly speaking this is correct — the equipment mentioned above all have firmware or ROM chips that allow the system to function. I can go on and usually do in more detail but the plain truth is that we don’t have this holistic approach yet.

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