August, 2003

For ten years Superior Controls has been automating biotech and pharmaceutical facilities. Typically, this meant providing the design and implementation of PLC- and DCS-based systems, control panels, MMIs, databases, validation documentation, start-up, and on-site IQ/OQ assistance.

But in the past couple of years, Superior Controls has been providing something more: electrical and mechanical installation and 21CFR Part 11 Gap Analysis. Several biotech companies have hired Superior Controls to review their existing automation systems and documentation to determine if their electronic records and signatures are compliant with the FDA's 21CFR Part 11 ruling. The result is a report or "Gap Analysis" which lists the deficiencies of each automated system.

Likewise, many biotech companies have requested that Superior Controls provide a complete turnkey installation, including electrical and mechanical installation with IQ and OQ validation of their entire automation system. Working with several reputable electrical/mechanical contractors, Superior Controls has been successfully installing these systems, some valued at more than $2 million.

The list above is a snapshot of the biotech projects being implemented during this past quarter. Included are their respective hardware/software solutions, and validation requirements. These projects range in cost from $40K to $1.8M. They range in size from 56 to more than 10,000 I/O points, and they range in implementation schedule from eight weeks to 12 months. All of these projects have also one thing in common: GAMP4.

GAMP4 or Good Automated Manufacturing Procedures (Ver. 4) are project methodologies and validation documentation requirements specifically for biotech/pharmaceutical automation/information projects. During the past 10 years, Superior Controls has developed quick and efficient project implementation strategies to comply with GAMP. We are proud of our project methodologies and publish them openly on our website. Please visit superiorcontrols.com if GAMP4 is of interest to you.