Medical devices and pharmaceutical standards and resources
This list encompasses laboratories as well as medical devices and pharmaceuticals. If you have information to add, please leave a comment.
ASQC Q2-1991: Quality Management System and Elements for Laboratories - Guidelines - E-Standard. Link current May 2005.
FDA 21 CFR Part 11. Electronic Records and Signatures. Links to resources. Added July 2005.
ISO 13485:2003 Medical devices: Quality management systems - Requirements for regulatory purposes. Link current May 2005.
Jack Kanholm. ISO 13485:2003 & FDA QSR (21 CFR 820) Documentation: Quality Manual, Procedures, Forms, and Checklists. Link current May 2005.
Orlando Lopez. CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry. ISBN 0-8493-2243-X. 2004. Added July 2005.
Process Analytical Technology Initiative (PAT). Summary by Cliff Evans: Design the plant correctly, identify the critical parameters, and then do risk assessments. Monitor and control the process by automatic means. Added December 2005.