Electronic Change Control System

Change control requirements for medical device companies are outlined in FDA's 21 CFR Part 820.30 (design changes), 820.40 (document changes), and 820.70 (production and process changes). 21 CFR Part 820 requires that manufacturers establish written change control procedures, which describe company-approved procedures. These procedures can be effected through electronic change control.

For pharmaceutical companies, written procedures are considered part of Current Good Manufacturing Practice (CGMP) outlined in 21 CFR Part 210-211. Any changes in production and processes must be controlled - meaning recorded, reviewed, and approved by the quality control unit. CGMP requirements are meant to prevent harm by building quality into the development and production of medicines.

Manufacturers certified to ISO 9001:2008 and ISO 13485 standards are required to ensure that any changes affecting the quality management system (including product requirements, design, and development changes) should be controlled. Manufacturers can use either paper-based or electronic change control systems.

The underlying message in these regulations is that all changes should be made according to approved (approval implies successful testing or thorough review/investigation) written company policies and procedures. Change control procedures have to be written as a way of standardizing instructions. Written procedures are also more reliable compared with passing on information verbally. "Uncontrolled" change in this context refers to modifications made without review and approval of the quality control unit and other departments affected by the change.

In the regulated and ISO manufacturing environments, strict adherence to approved policies and procedures is key in keeping operations in a state of control and it is what makes change control crucial. When considering methods for controlling change, a company can choose to implement a paper-based or electronic change control system.

Because companies now create and store most of their business information in electronic systems, it makes sense that documenting change would move to electronic systems, too. Electronic change control systems should support a manufacturer's business processes, allowing it to easily create change orders, submit change orders for review and provide all associated documents that instigated the change.

An electronic change control system also requires the use of electronic signatures. For FDA-regulated companies, an electronic signature is defined as "a computer compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent to the individual's handwritten signature."

Remember chaos? The use of an electronic change control system requires the development of a set of internal procedures known as standard operating procedures (SOPs) that control chaos. These clearly state when electronic signatures, electronic copies and paper copies are appropriate in the workplace. An electronic system sets rules for updating all electronic documents and mandates when and how electronic signatures will be used.