Problems We Solve

Document Control

In both FDA and ISO environments, document control is key to attaining quality and compliance. To control quality, one must control quality documentation, such as SOPs, policies, and quality manuals. Controlling quality documentation requires an effective document control system. Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid document control systems.

In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections or ISO audits.

EDMS is uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.