Electronic Records

Various articles about electronic records, including: E-Sign On The Bottom Line, How Raw Are Your Data, How Raw Are Your Data - 2000, Selecting A Part 11 Compliant System, Containment Of The Part 11 Problem and Computer (In) Security.

Various articles about electronic records:

  • E-Sign On The Bottom Line
    A Questions of Quality article covering a basic overview of 21 CFR 11 from the perspective of the chromatography laboratory. The article discusses hybrid systems as well as electronic hybrid systems.
  • How Raw Are Your Data
    The 1996 Questions of Quality article that escaped three months before Part 11 was published, however it considers that electronic records are better than paper raw data.
  • How Raw Are Your Data - 2000
    An update of the 1996 article with a definition of what constitutes electronic records for a chromatography data system. This is very useful after the 2003 Part 11 Scope and Application guidance for industry from the FDA suggests that companies define the electronic records for their systems.
  • Selecting A Part 11 Compliant System
    The article outlines approaches required to select a technically compliant solution to your legacy systems. Mentions redesigning or optimising your processes to make use of electronic signatures. This is taken up in the paper on Exploiting The Benefits Of Electronic Signatures.
  • Containment Of The Part 11 Problem
    Co-authored with Virginia Picot, the paper presents a discussion of how to contain the Part 11 problem and ensure that you obtain a Part 11 compliant environment through active vendor management.
  • Computer (In) Security
    Looking at the use and misuse of passwords and debating access control for applications.