eInfotree Electronic Document Management System 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Compliance

eInfotree Implementation

11.10(e)

Record changes shall not obscure previously recorded information.

Database records: If a database record is modified, a complete copy of the previous record is made and stored - not just the modified values. Record versions can be compared with changes highlighted. Thus, record values at any time since creation can be viewed instantly in the audit trail history.

Files: Embedded files must be checked out before any changes can be made. On checking in, the file is stored as a new version, with previous versions stored in the eInfotree system.

11.10(e)

Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

Audit trail records can be copied in electronic and hardcopy formats for review and copying, and can also be exported to desktop applications.

11.10(f)

Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
 

Only permitted sequencing of steps and events is allowed.

11.10(g)

Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
 

eInfotree contains all the specified authority checks. Refer to Section 11.10(d).

11.10(h)

Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
 

eInfotree contains device checks to verify valid source of data.

11.10(i)

Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
 

Not Applicable

Procedural Control.

11.10(j)

The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

Not Applicable

Procedural Control.