QUIZ#9: ELECTRONIC RECORDS / ELECTRONIC SIGNATURES
21 CFR PART 11 FINAL RULE

Evaluate whether each of the statements below is TRUE or FALSE.

  1. The requirements of 21 CFR Part 11 are applicable to medical device manufacturers only.

  2. An audit trail documenting changes to electronic records can be maintained on paper.

  3. "Legacy systems" (i.e., electronic recordkeeping systems and electronic signature programs already in use by a firm at the time 21 CFR Part 11 took effect) are not "grandfathered" under the Final Rule. If they do not comply with FDA's ERES regulations, older systems must be modified to reach a state of compliance or replaced.

  4. Any system that is accessible to its users by telephone (i.e., through modems) is automatically considered to be an "Open" system.

  5. It is possible to use handwritten signatures with an electronic record system.

  6. The FDA is already conducting inspections specifically to assess industry compliance with 21 CFR Part 11.

  7. According to the regulations, electronic records may be destroyed by a firm as long as printed copies of the records are retained.

  8. FDA does not endorse, certify or approve any specific electronic recordkeeping system or electronic signature systems.

  9. An e-record audit trail need only indicate the date and time of a change, and what was changed.

  10. A user ID/password combination can serve as an acceptable electronic signature.

  11. A firm must re-certify its electronic signature system with FDA every time a new employee with signatory authority joins the company.

  12. Electronic record and electronic signature systems need not be validated provided they are identified as "FDA approved" by the software developer.

How did you do? After you have taken the Quiz, request the answers for Quiz #9 via e-mail from accureg@regulatory.com. If you include your address, we'll send you a pocket book of the GMPs for Medical Devices (21 CFR Part 820) or for Finished Pharmaceuticals (21 CFR Part 211). Please be sure to specify which regulation you would prefer.

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