Change Control Software

While document change control software is used to comply with different regulations worldwide, many systems were developed with the requirements of the FDA in mind. The importance of document management has never been as apparent as it is in FDA regulations such as 21 CFR 211.100 for pharmaceutical companies (pertaining to written procedures and deviations) and 21 CFR Part 820 Subpart M for medical device companies (written records). In addition to FDA and other regulations, many document change control systems available in the market today were developed to help companies adhere to international quality standards such as ISO 13485 for medical device manufacturers and ICH Q10 for pharmaceutical companies.

Regulated companies, especially those complying with multiple regulations and standards, are increasingly relying on document change control software to manage their documents-based processes. It is important for them to remember that although regulations and quality standards may vary in their specific requirements, the overriding concern is the same: processes that directly affect product quality must be properly documented and such documentation process must be controlled to ensure product safety. This quality principle is the key driving factor for most regulated companies utilizing document change control systems.