Pharmaceutical Change Control Software

Using Document Change Control Software for Document Management

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.

Using Document Change Control Software for Change Control

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.

Benefits of MasterControl Document Change Control Software

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:

• Web-Based Platform

One of the major advantages of using document change control software systems is having a centralized location for all documents necessary for compliance. With MasterControl, users can go to a single place for all the critical documents they need. MasterControl is web-based so all authorized users will have access to the system from virtually anywhere 24/7.

• Mobile Access

With MasterControl users can access the system using a tablet or a smartphone. This capability is a distinct advantage over other systems and it can be very helpful for users working in a clean room or manufacturing floor, those out in the field, and those constantly traveling. Those users will be able to participate in documents-based processes even when they are not in front of their computers in the office.

• Explorer

MasterControl document change control software provides an easy-to-use tool called Explorers for easy search and retrieval of documents. Users can create an Explorer for every type of document, and every department can organize documents in a way that makes sense to them.

More information on benefits of MasterControl Document Change Control Software

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:

• Best-Practice Form

Provides a pre-configured form that simplifies collection and tracking of data throughout the change control process.

• Revision Control

Regulatory agencies typically scrutinize document change control systems for their revision control capability. MasterControl provides automatic revision history, including such information as reasons for every change, when it was approved, who approved it, and the approver's signature.

• Analytics and Reporting

MasterControl document change control software makes the change control process more transparent with the help of standard and customized reports that can summarize change orders by product, department, root cause, etc.