Based on recent guidance documents, the concept of change control and its management is interpreted in a much more global sense by today’s regulatory expectations from the minimal requirements as originally defined in 21 CFR 210 and 211. Change control systems today are expected to be designed in a way that provides a system to not only document and approve changes, but also to anticipate change within the quality organization. Modern approaches to designing change control systems include development of a centralized approach as opposed to decentralized approaches. This is an important consideration as an architectural quality design concept for a change control system.

Another important design feature to include in the change control management procedure is to carefully state where, within the quality organization, that the change control system is not applicable when performing certain operations. For exam- ple, under normal practice, equipment Standard Operating Procedures (SOPs) should state when preventative maintenance and calibration are to be performed. Without an exemption statement in the change control procedure stating that change control is not required when performing these routine calibration and maintenance operations, an expec- tation that change control be followed may be implied. Having this “exception” feature in the change control procedure, with a few listed examples, will likely preclude otherwise irrelevant questions from auditors and FDA investigators as to when change control applies (and when it does not apply) within the firm’s quality system.

Any well-managed quality system requires a documentation counterpart. For change control, just as with other document-driven quality systems like deviation investigations, a well-designed form is an integral part of the SOP. The change control form should allow unique identification of changes for tracking and monitoring purposes and ideally be easily accessed by user groups when needed. Electronic form distribution or use of shared drives under the organization’s computer network system is the most common method to meet the requirements.

Download the accompanying article, "Designing the Perfect Change Control System."