Furthermore, the software associated with an instrument can vary from firmware in basic instruments to servers and workstations for multiuser networked data systems.
Writing guidance for the qualification of this wide range of instrumentation and software is not easy, as qualification needs also depend on the intended use of the instrument or system.
Using a practical example, the validation of an analytical instrument in a MSR-QMS-regulated research laboratory will be shown and compared to a validation process in a strictly GLP-regulated area.
A summary of the experiences with the new quality system will complete this article and the advantages of high quality research results in industry will be discussed.
The white paper published by AAPS in 2004 (7) was the major input to USP The second source for guidance in a regulated laboratory comes from ISPE's Good Automated Manufacturing Practice (GAMP) Guide, which is seen by many as a standard for computerized system validation.
After the publication of version 4 of this guide in 2001 (11), ISPE published several "good practice guides" (GPGs) on specific topics that were intended to take the principles of the version 4 guide and tailor them for a particular subject or focus area.
An integrated approach is not only beneficial from a regulatory and auditable context, but it also is cost effective for the business.Thus, we describe the implementation process of MSR-QMS as a research specific quality management system in a global company.Furthermore, the implementation process in one specific research department will be highlighted.The first is USP general chapter on analytical instrument qualification (AIQ) (6), which was derived from an AAPS meeting on analytical instrument validation held in 2003.One decision that came from that conference was that the terminology being used at the time was incorrect, because the conference name itself should have referred to analytical instrument qualification.