Validation and 21 CFR Part 11

ePath Learning, Inc. is committed to continuous improvement of the software security, reliability and quality of our learning management technology services through the effective application of proven systems and software development methods, practices and techniques. ePath Learning utilizes best practices for software engineering and quality assurance to evaluate the correctness and quality of its complex software systems throughout the system development lifecycle (SDLC).

The Quality Assurance and Software Quality teams review specific documentation which is generated during each SDLC stage, in addition to other ePath Learning personnel with review and signature responsibilities. If a reviewer, for any reason, rejects a document, the development process is halted until the problem is resolved and approved.

Approval of all original documents generated during system development requires dated signatures by qualified ePath Learning personnel. Approved documents are filed manually and electronically in a secure and controlled environment. A Traceability Matrix maps the business requirements with the system requirements, system design, and test cases that satisfy them. ePath Learning’s Software Quality team is involved in the development of the Traceability Matrix and its continual update. Validation of ePath Learning processes and procedures can be obtained for all of our learning management technology releases.

Upon request, ePath Learning will host client audits at our corporate headquarters to review the documentation related to the design, development, testing, and implementation of releases. These audits routinely demonstrate our adherence to quality software engineering and testing principles. Based on all system documentation and client audit findings, ePath Learning believes that each new release of our learning management technology, meets the specified requirements of ePath Learning and our Clients. Our learning management technology has been developed according to a documented methodology and each release has been thoroughly tested. In addition, we test each release to ensure conformance with 21 CFR Part 11 for our learning management technology. Architecture of our learning management technology and our procedural controls remain unchanged, irrespective of new releases.

ePath Learning supports the unique documentation needs of its regulated Clients. Subject to the terms of a Client’s contract with ePath Learning, and upon written request, all applicable documentation will be made readily available for Client inspection and review at the corporate headquarters in New London, CT.