Certifiably compliant
Correlate Technologies announces a new K-Map-based solution designed specifically for the requirements of the United States Food and Drug Administration’s 21 CFR Part 11 regulations governing electronic records and electronic signatures.
The FDA explains Part 11 “is intended to create criteria for electronic recordkeeping technologies while preserving the agency's ability to protect and promote the public health (e.g., by facilitating timely review and approval of safe and effective new medical products, conducting efficient audits of required records, and when necessary pursuing regulatory actions).”
Dave Dexter, Correlate’s VP of business development, breaks it down in simpler terms: “Anything that comes to market that affects the human body must be documented, and every document must be found and submitted to the FDA upon request or the manufacturer faces heavy fines.”
For the Part 11 offering, Correlate is partnering with IBM (through the Notes/Domino environment) and IT&E International, which is providing domain expertise.
Correlate says it enables document certification and offers a user-friendly, template-driven approach and adds that this combination allows for quick process definition, lowering software and services costs and significantly reducing implementation time in achieving compliance.