Title 21 CFR Part 11 (FDA) compliance checklist for ApexSQL Audit

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations established by the United States Food and Drug Administration (FDA) as regulation on electronic records and electronic signatures (ERES). Part 11 defines the criteria under which electronic signatures and electronic records are trustworthy, reliable and comparable to paper records

All SQL Server systems that store data which are used in process of making quality decisions or any data to be reported to the FDA must be compliant with Title 21 CFR Part 11

SOX compliance checklist for ApexSQL Audit

The Sarbanes-Oxley Act (SOX) of 2002 is mandatory to all organizations regardless of their size and all must comply ant it serves “to protect investors by improving the accuracy and reliability of corporate disclosures made pursuant to the securities laws.” 1