21 CFR Part 11 Compliance

21 CFR Part 11, sometimes referred to as Part 11 compliance, is the FDA’s imposed criteria where electronic records and electronic signatures are to be considered as trustworthy, legitimate and reliable as paper-based records.

Cobent’s ‘Learning Compliance Suite’ (LCS) is a 21 CFR Part 11 compliant Compliance Training and Learning Management System (LMS) and has assisted many FDA regulated organisations pass FDA audits.

Electronic Records

LCS complies with the strict record-keeping guidelines on:

Security
Access to the system is controlled via advanced permission settings. Visibility is granted at a granular level by pre-defined groups i.e. job-role and responsibilities, location, department etc. The system can be deployed on your own Part 11 compliant environment or Cobent can provide a Part 11 hosted package.

Traceability
Organisations have the ability to upload or record training data against any training requirement be it, e-learning, assessments, classroom-based or on-the-job training. Records are centrally stored and granular access is granted via security settings.

Auditability
All records are retained within the system; records cannot be deleted and amendments or updates made are recorded with the timestamp, name of the person who made the changes and any associated notes. Inspectors or auditors with access can easily drill-down into the records for more information. The system is fully auditable in accordance to FDA requirements and readily available for internal and external audits.

Electronic Signatures

E-signature functionality is a key feature within the system and is compliant with Part 11 guidelines to be considered to be as valid as handwritten-signatures. E-signatures are unique to the individual and formed from a username and password.

Single or multiple e-signatures can be captured throughout the training process as part of validating that an individual has completed, read and understood a training requirement or a supervisor has approved or reviewed the completion of a training element.

If you would like more information contact us on info@cobent.com

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21 CFR Part 11 Compliance

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