Online Training for

Electronic Records and Signatures

Get a breakdown of regulatory requirements for 21 CFR part 11 for electronic signatures, and good documentation practices in a digital world.

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Electronic Records and Signatures

This web based training modules gives an overview of electronic records and signatures. It goes through requirements for 21 CFR Part 11, Public Docket 92S-0251, open and closed systems and electronic signatures. The course also discusses the importance in using good documentation practices as we transition to a more paperless society.

Training is done through ePath, the PathWise online learning management system. ePath is targeted knowledge based learning done on the web. Our knowledge-based WBT focuses on terms, definitions, regulations and expectations.

The purpose of this web based training course is to gain a clearer understanding of electronic records and signatures as they pertain to:

21 CFR Part 11.
Public Docket No. 92S-0251.
Controls in Closed and Open Systems.
Signature Requirements.
Good Documentation Practices in electronic records.

Optimize productivity and training time.
Flexible mobile learning using a desktop, laptop, tablet or mobile device.
Fulfill new hire and annual FDA training requirements.
Maintain compliant electronic records and signatures.

This web based training is taught as an e-learning course. It can be taken through our ePath learning system on a desktop, phone, or tablet. This training is appropriate for all employees involved in the manufacture or support of the medical device, pharma, or biologics industries.

The Electronic Records and Signatures online training module is worth 0.1 CEU credits.

PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.

Learners must complete the following in order to earn CEU credit:

Verify your electronic signature
Complete the full course module on ePath
Complete the full instruction module
Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment).

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