References

List of References for Validation Activities

The following list of references are used as the basis for establishing the SDLC process at Cognigen. Cognigen uses the Unified Development Process SDLC methodology. Policies and procedures are available for review and reference from the intranet QMS pages, and from the SDLC map.

Food and Drug Administration References

21 CFR Part 11: Electronic Records; Electronic Signatures Final Rule , 62 Federal Register 13430 (March 20, 1997)

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Office of Device Evaluation, Center for Devices and Radioloical Health, Food and Drug Administration, January, 2002.

Glossary of Computerized System and Software Development Terminology.

Computerized System and Software Development Terminology, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, August 1995.

Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, Office of Device Evaluation, Center for Devices and Radioloical Health, Food and Drug Administration, August 1995.

Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radioloical Health, Food and Drug Administration, September, 1999.

Guideline on General Principles of Process Validation, Center for Drugs and Biologics, & Center for Devices and Radioloical Health, Food and Drug Administration, May, 1987.

Other References

Booch,G., et al. The Unified Software Development Process. Addison-Wesley Longman, 1999.

Chamberlain, R. Computer Systems Validation for the Pharmaceutical and Medical Device Industries. Alaren Press, 1994.

Cognigen Quality Management System References

SD 1.0 Software Validation Policy

SD 1.1 Software Validation Procedure

Cognigen SDLC Process Map: Procedures, Work Instructions, Examples, and Forms (Created in PERSPECTIVE)