File Based Systems

Examples of Files/Documents that are subject to 21 CFR Part 11 are:

  • Laboratory raw data files from instruments
  • PLC/SCADA history or configuration files
  • AutoCAD drawings storing equipment/system specifications
  • MS Word files storing SOPs, specifications, or validation documents

Selected 21 CFR Part 11 Issues for MS Access Applications

  • Files are stored on local hard drives or network servers, and maybe easily accessible to unauthorized individuals. Files may be modified, copied or deleted by unauthorized personnel with no record of these events.
Lack of Audit Trail:
  • There is no audit trail of changes made to the file, even when made by authorized personnel.
Lack of Version Control :
  • There is no version control of such files. Any changes made to the file obscures the previous version of the file.
Lack of Electronic Signatures :
  • There is no provision for electronic signatures.

Data is stored in a single flat file which can be subject to accidental erasure or corruption.