FDA Compliant Standard Operation Procedures

Change Control Management Software
Electronic Signatures (21 CFR Part 11)
Corporate Repository for OSHA-required MSDS’s (Material Safety Data Sheets)

Optical Image Technology, Inc. (OIT) provides an electronic system used for the circulation, review, approval, and distribution of FDA-regulated documentation required by the Current Good Manufacturing Practices and Quality System regulations (21 CFR Parts 211 and 820).

This documentation includes:

Standard Operating Procedures
Finished product specifications
Packaging and raw material specifications
All other records associated with the manufacture, testing and distribution of drug products

This system has been successfully installed and implemented throughout a multi-divisional, multi-location company involved in the manufacture of pharmaceuticals, diagnostics, pet products, medical devices and consumer products.

A paper-intensive system including microfilm and filing was replaced with a system using DocFinity Imaging, COLD-ERM, BPM/Workflow, browser access, and the Electronic Signature Server modules.

The system, with over 350 users, has resulted in the following benefits:

A one-third workforce reduction in the documentation area
A 95% decrease in the amount of paperwork circulation and distribution
A reduction in the time needed to circulate and approve documents in the change control system
The auditing of all activities in the system, enabling users and administrators to determine what is going on at all times during the review, circulation, and approval process
A decrease from days to minutes to process information requests from the Credit department

As required by regulation, the company notified the FDA regarding the use of this system. Prior to the notification, an independent computer validation company was brought in to perform a critical evaluation of all aspects of the system for compliance with 21 CFR Part 11. This review included design, implementation, and validation. It was the opinion of the consultant that the system was in substantial compliance with the regulations. Additionally, the system was examined as part of a comprehensive FDA inspection and no FD 483 comments were made.

The OIT system implemented at this company won the prestigious Process Innovation Award from Kinetic Information, which honors superior applications for their business effectiveness. The winning deployment includes a pioneering content and process management system that utilizes e-Signature and electronic workflow technology in its Internal Procedures Division.