What are minimum requirements for Maintaining an E-Record for Equipment Data

  1. what are the requirements for maintaining compliance to part-11. …

    how do you handle the same in a lab, with multiple equipments, and some of them are connected to SDMS and some are not connected to SDMS.

    do you maintain separate user id and password for each instrument, or … what is your approach towards part-11 compliance? is it acceptable…if…
  2. if i maintain a e-records with audit trail; but take printouts + instrument usage log books to maintain traceability of the analysts.
  3. if we transfer the e-records to SDMS and process the details there. (while e-records are maintained with required audit trails?)

Please expand your question or statement. There are no minimum requirements; there are requirements stated in 21 CFR Part 11. Have you started your investigation on the general guidance document?

sorry for delay…
for minimum requirements, i meant, that
it is allowed to rely on prinouts, while maintaining the e-records (audit trail) (in this case, it is not mandatory to have e-signatures i.e., unique user ids and passwords)

for stand-alone offline activities above scenario is simple to interpret.

Now, consider scenario where we add ELN or LIMS to link with above requirements, e-signatures get triggered for ELN & LIMS.
the question, is hwat happens to the requirements of e-signatures to the above equipments?

thank you.

You just answered your own questions. It al depends on the system, functionality, and complexity. A GAP assessment is performed to identified those minimum requirements.