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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Conformance to the specification is achieved visually with no further qualification required.

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

In devising this classification system, the GPG proposes to include balances, pH meters, centrifuges and glass washers as “laboratory computerized systems”.

Installation of the instrument is relatively simple and causes of failure can be easily observed.

This is shown in Figure 3 on the left-hand side. 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 validaton documented for regulatory reasons, for example, authorized users and access levels required by both predicate rules and 21 CFR The publication offers guidance for addressing strategic and tactical computer system validation issues such as: Once the software functions have food 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.

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. 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.

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.


The comparison of the GAMP Guide and the Laboratory GPG software classifications are shown in Figure 3 on the right-hand side of the diagram and the validatoon in the middle indicate how the two classification systems are mapped and are compared with each other.

However, at least the main computer validation subjects are covered in the whole life cycle including system retirement. You can’t operate the equipment without the validaton and vice-versa.

Although this is usually a unique and custom application.

Here, there needs to be a specification for the macro name plus version numberthe calculation or the programming or recording of the macro. Until we have this integrated approach there will be confusion in this area. This reflects the fact that we can purchase a system, install it and then operate it as shown on the right-hand of Figure 1. 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.

Integrated Approach to Computer Validation Practicd Instrument Qualification What we really need for any regulated laboratory is an integrated approach to the twin problems of instrument qualification and computer validation. The laboratory is not a unique part of a facility anymore than production is. For example, why 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?

The vast majority of equipment practuce systems in our laboratories are similar to this, but consider the question: As with any performance appraisal system, let’s start with the good news first and work our way downhill afterwards.

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

Integrated terminology covering both the qualification of the instrument and validation of the software. We need to have an integrated approach that recognizes that we need a combined approach to qualifying the instrument through the controlling software that also needs to be validated at the same time.

However, regardless of the approach taken, the system configuration must be documented partly for your business to allow reconfiguration of the system in case of disaster but also for performing the validation.


This can be as simple as selecting which function will be used from two or three options or, in more complex systems such as a laboratory information management system LIMSusing a language to set up a laboratory procedure or method. A definition for qualification is defined in ICH Q7A GMP for rpactice pharmaceutical ingredients as Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly and actually lead to the expected results.

This is because most guidance has concentrated largely on computerized manufacturing and corporate systems, rather than laboratory systems. However, this goes against how the rest of the organization works; it is important to emphasize that laboratories are not unique islands inside an organization — rather they are an integral component of it. From my perspective, this is wrong and emphasis should be placed on defining the intended purpose of the system and hence functions of the instrument and software that are required first and foremost.

Examples of instruments in this group are balance, IR spectrometers, pipettes, vacuum ovens and thermometers. Commercially available software that has been qualified does not require the same level of testing. It is the computerized system practkce controls the whole — not the instrument.

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

It really depends on the functions that the equipment or system does and how critical it is. Many suppliers have always performed equipment checks to confirm functionality of their equipment to defined specifications, both prior to and after installation. OK this approach is simpler but the only consideration of the goof aspects is limited to data storage, back-up and archive.