Laboratory Computerized Systems
The validation of computerized systems is required by the OECD(Organisation for Economic Co-operation and Development ) principles of Good Laboratory Practice. (Consensus document no. 10). " All computerized systems used for the generation, measurement or assessment of data intended for regulatory submission should be developed, validated, operated and maintained in ways which are compliant with the GLP principles".
The objective of any chemical analytical measurement is to get consistent, reliable and accurate data. Proper functioning and performance of analytical instruments and computer systems plays a major role in achieving this goal. Therefore, laboratory computer system validation (CSV) should be part of any good analytical practice and this is equally important for those working in a regulated and in accredited environment.
Regulogix provides outright solutions for building a quality environment for your quality assistants i.e., Laboratory Computerized Systems like HPLC, LC, Mass Spectrophotometer, GC, FTIR, KF Titrator, TOC, Stability Chamber etc. We recognize the profound impact of the FDA’s 21 CFR Part 11 regulations on the operations of our clients using the laboratory computerized systems. Regulogix helps ensure that your instruments meet performance standards at the point of installation through proven performance testing and documentation.