The analysis engine links to these symbols to implement and expose the FIRMWIRE interface, its common analysis API, to automated analyses (right block of Figure 1).

The machine will be built to comply with GAMP 4 guidelines and when completed will be ready for the validation process.įor example, the stan- dards and guidelines developed by professional societies, the proposed subpart L to the GMP and the new GAMP 4. Simpler Classification of Laboratory Instrumentation Rather than use the impractical and overly complex classification of seven categories proposed by the GAMP GPG (2), I would propose that we base the instrument qualification ele- ment classification upon the AAPS/ approach in one of three groups (3,4) plus the GAMP 4 categories (5) for the software ele-ments to find the overall system approach to combined EQ and CSV. Software ClassificationAlthough software is more complex, it should be classified using the current GAMP 4 software categories to ensure consistency with the rest of the organi- zation rather than use the laboratory classification suggested earlier (2). The cGAMP software regulatory package shall be provided in EnglishThe software development has to follow the life cycle approach described in GAMP 4.

Another reference is GAMP 4 (issued by ISPE )5.40The validation assessment system defined by the ISPE is also a very useful analysis technique to use so that resources and effort are appropriately targeted on critical sys- tems.5.41IQ and OQ of computer hardware and software are often treated entirely separately from equipment IQ/OQ.

Gamp category 4