Below are links to additional resources.
Computer System Validation
www.computersystemvalidation.com
David Nettleton is a 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. Services include compliance related to product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
ISO Guidance Center
www.isogc.com
John Adkins is the founder of the ISO Guidance Center. He has over 20 years experience developing ISO documentation for our clients, your QMS can meet the requirements of the Internal Standards with the aid of our services. We have Teamed up with The 9000 Store to offer a Complete Line of documents covering ISO 9001, AS 9100, TS-16949, ISO 13485 and ISO 14000. Our Mission is satisfy our customers by providing easy to understand Do-it-Yourself materials that will aid them to become certified to International Standards.
Citrix GoTo Meeting
www.gotomeeting.com
Whether your meeting is scheduled in advance or started in one click, GoToMeeting makes it easy for you to meet online with anyone anywhere – on either a PC or Mac® computer.
Smizer Perry
www.smizerperry.com
Smizer Perry specializes in marketing communications and graphic design for the business to business technology industry. They have been helping clients differentiate themselves for 24 years, by providing clear, consistent, creative, strategically sound, and effective communications.
SOS International
www.sosintl.com
SOS Intl is a unique organization, serving the electric industry in ways that no one else does.
21 CFR Part 11
www.21cfrpart11.com
The 21CFRPart11.com Web site provides access to information on the rule and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators. On this site you will find the latest conference, meeting and seminar information as well as links to vendors and consultants who can help the pharmaceutical community with issues of compliance with regulations and productivity.
Vida Data Systems
www.vidadatasystems.com
We have over 11 years of experience in developing and implementing information systems for biopharma companies. We have experience in working with a wide range of client groups from scientific, to clinical, to legal. Our team has held software development and leadership positions in IT and Informatics within biopharma companies.
PharmOut Information Technology
www.pharmoutit.com
Food and Drug Administration
www.fda.gov
FDA Warning Letters for Compliance Failures
FDA Inspection Guide
FDA Compliance References
International Organization for Standardization
www.iso.org
21part11 Discussion Forum
Discussion Forum
A forum for issues and questions regarding 21 CFR Part 11. The 21CFRpart11.com Discussion Mail List is for comments or questions about the 21 CFR Part 11 Electronic Records Electronic Signatures Rule.
Other Sources of Information
www.pharmamanufacturing.com
Quality web directory
The Quality Portal