Cook Pharmaceutical Solutions Selects QUMAS DocCompliance for Enterprise Compliance Management.

Business Editors

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Dec. 18, 2000

QUMAS Solution Automates Document Control Process for Contract

Manufacturer in Compliance With FDA's 21 CFR Part 11 Ruling On

Electronic Signature

QUMAS Inc., the leading provider of Enterprise Compliance Management Solutions for regulated industries, today announced that Cook Pharmaceutical Solutions, a division of Cook Imaging, has implemented DocCompliance.

In addition to Cook Imaging's proprietary product Oxilan, a radiographic contrast media, Cook Pharmaceutical Solutions (CPS) offers a complete line of pharmaceutical contract services. QUMAS' DocCompliance will enable Cook to automate their document control process, decrease document turnaround time, and maintain compliance with the Federal Drug Administration's ruling 21 CFR Part 11 on electronic signature.

John Brooks, manager, information technology services for Cook Pharmaceutical Solutions said, "As a contract manufacturer, we understand that the primary concern for our customers is speed to market, and any production delay can cost them money and adversely affect their market launch. Speed and efficiency are critical, so we wanted a proven, out-of-the-box solution that would enable us to quickly transition from a manual to an automated system." Brooks noted that CPS initially evaluated Qumas and two other potential solutions. "One solution we evaluated," added Brooks, "was not 21 CFR Part 11 compliant, which was one of our key selection criteria. Plus, the implementation process would have to be outsourced to another company. QUMAS offered a solution that was easy to install, easy to use, and fully compliant. Our choice was obvious."

Previously, document management was a manual process that did not maximize operational efficiencies and could have taken as long as four weeks to complete. Now, Brooks added, "We estimate that DocCompliance will enable us to reduce document turnaround time, which includes document review, making changes, and sending to production, from two weeks to a couple days.

"DocCompliance is going to allow us to tightly control our documents, including printing. It will also prevent the circulation of non-current versions, and will track all training documents. This takes us to the next step, which is an enhanced data archiving system. Our manual system required us to physically store documentation in several cabinets distributed across three buildings. Now QUMAS will enable us to archive everything electronically," said Brooks.

CPS manufactures a variety of sterile product dosage forms including solutions, suspensions, and freeze dried-powders encompassing human and veterinary small molecule, biologic, vaccine and protein pharmaceuticals. CPS has the expertise and the industry's premier technology to take sterile products from a novel idea, to full-scale commercial manufacturing with the regulatory support required throughout the process.

In less than a decade, Cook Pharmaceutical Solutions has grown to be one of the nation's largest parenteral contract pharmaceutical manufacturers. The company has expanded its capacities for syringe filling, lyophilization, contract packaging and labeling/packaging materials for blinded clinical trials.

Kevin O'Leary, president of Qumas said, "We are pleased that Cook Pharmaceutical Solutions has chosen DocCompliance to automate their compliance management processes. Our solution will enable them to quickly transition to an automated environment that is fully compliant with all FDA guidelines on electronic signature."

About QUMAS

QUMAS, Inc. is the leading developer of Enterprise Compliance Management Solutions designed to help regulated industries ensure regulatory compliance. For over a decade, QUMAS has been providing industry-proven Enterprise Compliance Management solutions to market leaders in the pharmaceutical, medical device, biotechnology, and contract research industry sectors.

Using advanced technology and regulatory domain intelligence, QUMAS' pre-packaged compliance management solutions automate critical document processes and dramatically reduce document cycle times. QUMAS solutions deploy rapidly to deliver FDA (including 21 CFR Part 11 ruling on electronic signature and records), EMEA and ISO-related best practices for the automation of controlled documentation and electronic regulatory submissions.

QUMAS services include validation, user training, migration services and technical support as part of a total software and services offering. QUMAS, Inc. is based in Cork, Ireland with US headquarters in Florham Park, NJ and additional offices throughout the United States. For more information, please visit our Web site www.qumas.com or contact QUMAS at 973/377-8750 (North America) or + 353 21 4320050 (Europe).