21CFR PART 11 ER and ES

How the 21cfr part 11 electronic records and electronic signatures useful to QC is it necessary?

The Role of 21 CFR Part 11 in the QC Laboratory:

The requirements of Part 11 are highly relevant to the electronic records and computer systems found in GCP, GLP and GMP (good clinical, laboratory and manufacturing practice - collectively referred to as GxP) regulated laboratories. This relevance arises from

  • the nature of laboratory data (often so complex that paper copies do not capture the full richness of the information contained in the electronic form)

  • the importance of the data (likely to be highly product- and/or patient-critical)

  • the nature of the computerized systems producing and processing these data (typically specialized, requiring expertise in operation and often connected to other hardware thereby requiring logical device checks)

In my opinion, the purpose of laboratory systems is to provide ‘valid analytical data,’ a concept comprising two parts. First, a valid analytical measurement is made and second, the original records of this measurement are created, modified, processed, copied and stored in a reliable manner. When these are electronic records, we should use systems and processes that substantially meet the spirit and letter of 21 CFR Part 11. In other words, through a valid analytical measurement with the security of Part 11-compliant procedures providing valid analytical data.