GAMP Good Practices Guide for Validation of Laboratory Computer Systems
GAMP Good Practices Guide for Validation of Laboratory Computer Systems
The “GAMP Guide for Validation of Automated Systems (GAMP 4)” is recognized as industry standard for computer validation. While this guide is an excellent framework for computer validation in general it is not detailed enough for specific applications, for example, laboratories. On the other hand because of their criticality laboratory computers are right on target of FDA inspections. To close the gap ISPE/GAMP has developed a special Good Practice Guide (CPG) for laboratory computer systems “ISPE/GAMP Good Practices Guide: Validation of Laboratory Computerized Systems, 2005 “. The guide is expected to be the single most important reference for automated laboratory systems from stand alone automated systems to complex networked systems and the FDA and EU agencies are using GAMP guidance as reference. To learn more about the guide read the Agilent Exclusive Monthly Compliance News and receive a free SOP or register for the Labcompliance Audio Seminar.
