A recent FDA 483 observation highlights a firm’s failure to maintain proper backup files and secure electronic data systems for laboratory instruments.
…..Failure to maintain a backup file of data entered into the computer or related system.
Specifically,
a.Your firm is unable to show electronic raw data or assurance that hard copy data is secure from alteration, inadvertent erasures, or loss for your atomic absorption spectroscopy, ultraviolet-visible spectroscopy, or infrared spectroscopy instrument utilized for analysis of drug products including, but not limited to…
b.Your firm currently has no requirements or procedure in place for a review of electronic data or audit trail prior to release of COAs.
Regarding part A of the observation, these instruments are routinely used for critical quality control testing of drug products, making their data integrity essential for ensuring product quality. The ability to manipulate data produced by these instruments is an egregious quality failure.
Even more concerning, the facility had no requirements or procedures for reviewing electronic data or audit trails, along with no systematic review process prior to releasing COAs.
This observation is in violation of:
- 21 CFR Part 211.68: Requires automatic data processing systems to have adequate controls to prevent unauthorized access or changes to data
- 21 CFR Part 211.180: Mandates that records be retained as raw data or as true copies
- 21 CFR Part 11: Establishes requirements for electronic records and electronic signatures
To remediate this observation, this firm would want to establish comprehensive backup systems that automatically store data from the various. Additionally, implementing access controls would ensure user authentication and audit trails.
Reading 483’s is a fantastic action to understand FDA inspection trends. Text +1 (732) – 609 – 6769 to talk to a sales representative about joining GMP Trends. Quality is a competitive advantage – Investing in a GMP Trends License for your quality team will yield significant cost-savings for your quality system.
