Published by: Marketwired
Compliance with 21 CFR 11 Gives FDA-Regulated Enterprises Data Security
SAN JOSE, CA – Jul. 11, 2012 ZL Technologies, Inc., the leader in records management, archiving, compliance and eDiscovery software for large enterprises, has announced compliance with Title 21 CFR Part 11 of the Code of Federal Regulations (CFR) for guidelines on electronic documents and electronic signatures. Part 11 or 21CFR11, as the section is commonly known, refers to the procedures which FDA-regulated industries must follow to ensure that electronic documents and signatures are secure and equivalent to their hard-copy counterparts.
Compliance with 21CFR11 is a key feature for players in the pharmaceutical, healthcare, biotech, and medical device industries. By giving the needed control over the electronically stored information (ESI) that is required by detailed FDA guidelines, companies may more easily integrate newer electronic data into existing systems. Furthermore, with patient information and records still existing in both paper and electronic formats in some settings, 21CFR11 compliance ensures that all data may be maintained with the same degree of security with regard to FDA expectations.
ZL is pleased to announce this further compliance capability in a software platform already recognized for compliance strength and Big Data management. Unified Archive®, designed for the large enterprise, continues to offer competitive advantage via scalability of its unified architecture and continual addition of stringent compliance benchmarks across multiple industries.