During the performance of an analysis, many records such as the output from analytical instrumentation are created in electronic format.

Annex 11 & 21 CFR Part 11

Electronic records in the pharmaceutical industry are regulated by Annex 11 in the European Union and Pharmaceutical Inspection Convention countries, and 21 CFR Part 11 in the United States.

Challenges Facing Electronic Records

Assuring the integrity of electronic records presents some particular challenges, such as, in the absence of appropriate controls and safeguards, it is possible to:

• Alter and manipulate records without leaving any evidence of the change
• Both intentionally and accidentally delete records leaving no evidence the original record ever existed
• Lose all electronic records held by a system in the event of a computer crash

Regulation Mandated Controls

In light of these challenges the regulations mandate the following controls and safeguards are established:

• Restrict access to computer systems to authorized personnel
• Establish adequate access and e-signature controls
• Establish appropriate privileges for users
• Establish audit trails to record all changes made to records
• Maintain a record of current and past users
• Ensure all staff are competent to use the system
• Administrative controls
  • Define and document the e-records created and/or maintained by the system
  • Control Changes
  • Back up the system at appropriate intervals