Need to access your industry standards and regulations? Visit our DocXellent resources below for more useful information on document control systems. If you want to know how document control software can help you meet all necessary requirements contact us today.
FDA: Good Manufacturing Practices
The U.S. Food and Drug Administration provides guidance, compliance and regulatory information. Current Good Manufacturing Practices (CGMPs) are detailed on this site.
FDA 21 CFR Part 110
The U.S. Electronic Code of Federal Regulations details current good manufacturing practice in manufacturing, packing or holding human food.
FDA 21 CFR Part 11
Part 11 of the FDA 21 CFR outlines the regulations related to electronic records and electronic signatures, in both scope and application.
The FDA CFR Title 21
The Food and Drug Administration Code of Federal Regulations Title 21 outlines the rules related to electronic records and electronic signatures. Full details can be found on the U.S. Food and Drug Administration’s website.
European Commission Good Manufacturing Practice (GMP) Guidelines
This site details the rules governing medicinal products in the European Union (E.U.) including guidance and good manufacturing practices for medicinal products for human and veterinary use.
OSHA 29 CFR Standard Number1904
The Occupational Safety & Health Administration Standards – 29 CFR Number 1904 outlines the Record Keeping standards within the U.S. These standards can all be found on the OSHA website. Document control software fills an important role in helping companies meet these standards.
SQF Institute Standards Management
The SQF Institute is recognized by retailers and foodservice providers around the world who require a rigorous, credible food safety management system. Their website provides useful audit checklists, guidelines and rules in English, Spanish, French Canadian and Japanese.
The International Organization for Standardization – ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. These Industry standards and regulations help companies and organizations around the world to ensure that their products and services meet customer’s requirements and that quality is consistently improved. Information about principles and management system standards is available on the ISO website.
Computer System Validation
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.