With electronic record keeping comes the possibility of data tampering. FDA 21 CFR Part 11 was established in August 1997 to govern the use of electronic records and electronic signatures. This regulation outlines the criteria whereby electronic records and signatures will be considered equivalent to paper records and handwritten signatures. The regulation covers electronic records throughout their lifecycle. This includes creation, modification, storage, final submission to the FDA, and audit.

21 CFR Part 11 is designed to ensure that the data stored and modified via electronic media are trustworthy and transparent. Source data containing critical information relating to compliance must be reliable and authentic. Data integrity must be guarded and monitored, preventing unauthorized modification of the system. A detailed audit trail of all user activities must be kept and made available for audit activities.

A vendor cannot claim that their software products are certified 21 CFR Part 11 compliant. They can only claim that their product contains all of the Technical Controls for 21 CFR Part 11 compliance. The ultimate responsibility for 21 CFR Part 11 compliance lies with the system owner and system integrator.

Use of an Electronic Compliance Monitoring system can assist in compliance with the regulation. Med-ic ECM incorporates several 21 CFR Part 11 compliance controls. CertiScan *.tdf (trial data file) files are in binary and checksummed format proprietary to IMC to ensure tamper proofing.

Complete and accurate copies can be viewed on screen using Med-ic CertiScan Software. Complete and accurate electronic copies are available by exporting the raw data files to .csv (comma separated value) files for viewing and printing in spreadsheets like MS-Excel. Med-ic obtains patient compliance data directly from the source and bypasses much of the need for complex rules of recording information, offering significant cost savings in the capture of patient compliance data.

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