21 CFR Part 11 Complaince

  • Electronic records equivalent with paper records
    • Storage, retrieval and copying in full retention period
    • Submitting to FDA
  • Protection of electronic records
    • Security (physical and logical)
    • Validation
    • Audit trail (who did what, when including reason where req.)
  • Permission to use of electronic signature
    • Equivalent with handwritten signatures
    • Name, date and meaning
    • Linking of signature to record
    • Unique for an individual

Data integrity / ALCOA data

  • Attributable data must be recorded so that it can be linked to the unique individual who produced it. Every piece of data entered into the record must be capable of being traced back to the time it was taken and to the individual who entered it.
  • Legible data must be traceable, permanent, readable, and understandable by anyone reviewing the record. This is expanded to include any metadata pertaining to the record.
  • Contemporaneous data are data that are summarily entered into the record at the time they are generated.
  • Original data, or the source data, is the record medium in which the data was first recorded. An original data record should include the first data entered and all successive data entries required to fully detail the scope of the project.
  • Accurate data are correct, truthful, complete, valid, and reliable. Controls put in place to assure the accuracy of data should be implemented on a risk-based structure.


  • Multi factorial authentication solutions — such as those combining biometrics, password protection and other measures — are also gaining in popularity, especially as U.S. government federal information processing standards (FIPS 201) have been mandated.
  • The use of biometrics becomes more prevalent in pharmaceutical environments — encouraged by the stipulations of 21 CFR Part 11.