As is widely known, the FDA posts its observations on their website, including inspectional observation summaries for each year.
While the list includes observations across many product areas and items, perusal of the summaries reveals some common observations that, potentially, could be addressed through automation that included 21 CFR 11 compliant software.
Lack of audit trail capabilities was an observation. A few of the FDA descriptions included commentary such as the following:
Manual records were also an issue. One observation stated that the investigator had to reassemble torn raw data records after finding them in a waste area.
In 2014, the FDA sent warning letters to companies for similar incidents regarding data quality, including:
Automated technologies provide system security and audit trails such that only authorized users can manipulate data, and that manipulation is tracked and reportable. In addition, automated capture of sample data ensures the comprehensiveness of any reporting.
While auditable processes are a critical component to a successful, auditable, operation, the inclusion of automation and technology can potentially eliminate some of the observations mentioned above.
Learn how organizations can utilize automated rapid methods in pharmaceutical quality control labs this free guide.