Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.
In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.
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.
It is not uncommon for companies using document change control software to manage their documents to also use it to manage change control. Regulations such as those enforced by the FDA clearly express the need for change control, including 21 CFR 211.100 for pharmaceutical companies (pertaining to production and process change) and 21 CFR 820.70 for medical device companies (production and process control).
Regulated companies also use document change control systems to comply with change control requirements that can be found in international quality standards such as ISO 13485 (Section 7.3.7, manage design and development changes) and ICH Q10 Pharmaceutical Quality System (Section 3.2.3, change management system).
In choosing software, companies should remember that an inadequate change control process can make them vulnerable not only to regulatory actions, but also product liability actions.
MasterControl quality and compliance software is a fully integrated web-based solution that provides document change control systems for both document management and change management. It automates and streamlines not only the document control and change control processes, but all other quality processes, including audit management, training control, CAPA, and nonconformance management.
For companies primarily interested in document management, MasterControl document change control software reduces document cycle time by automating delivery, notification, tracking, escalation, and approval of documents. In addition, it provides:
For companies primarily concerned with change control, MasterControl document change control system automates all tasks related to the change control process, including routing, follow-up, escalation, and approval of change orders. It also provides:
To learn more about document change control software systems, please feel free to contact a MasterControl representative.
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