Are you protecting your lab data from deletion or alteration?

A company recently received the following observation regarding lab data:

….. Established laboratory control mechanisms are not followed and documented at the time of performance.

Specifically, data captured from the following laboratory testing systems is not adequately protected from deletion or alteration. For example:

a.         There are approximately …. users in Quality Assurance with Administrator access privileges in chromatographic testing software, which is used for HPLC assay and impurity analyses of finished drug products and stability samples, and GC testing of raw materials.  Additionally, the system audit trail captures user log-in and log-off, but not any details of data capture, processing, or storage/saving.

b.         Data from the Fourier Transform Infrared Spectrophotometer, which utilizes … software, is stored on the …computer, and files allow “Full control”, “Modify”, and “Write” when accessed through the computer’s operating system. The system is used to test raw materials.

According to the Code of Federal Regulations (21 CFR 11.10 Electronic Records), persons who use systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include:

protecting lab data
  1. Validation of system
  2. Accurate and complete records
  3. Protection of record
  4. Limiting system access
  5. Audit trails to record actions that create, modify or delete records, etc.

For more information on implementing controls for electronic systems, protecting lab data, and how to ensure data integrity, refer to the FDA Guidance Document, Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application August 2003.

To view more observations pertaining to data integrity, refer to the following GMP Trends® Issues: 1061, 1056, and 1052

Stay in Compliance! Subscribe today!

Become A Subscriber And Stay Ahead of the FDA

To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format. Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!