Campbell Informatics / University College Cork Technical Data Standards Collaboration Gains Enterprise Ireland Support

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Campbell Informatics and UCC's School of Pharmacy have entered into a 2-year Enterprise Ireland sponsored Innovative Partnership Project, effective August 2007, to produce Technical Data Standards for the BioPharma Industry.

The project provides a unique opportunity to deliver a world-class knowledge base in support of Manufacturing Science and Technology (MS&T). Our life science clientele will benefit greatly as a result.

Campbell Informatics and UCC's School of Pharmacy have entered into a 2-year Enterprise Ireland sponsored Innovative Partnership Project, effective August 2007 to produce Technical Data Standards for the BioPharma Industry.

The project - "BioPharma Quality Engineering Data Management" - involves the compilation of interdisciplinary datacentric standards in a structured re-usable format. This project is targeted towards the heavily regulated and paper dependent Pharmaceutical and Biopharmaceutical industry in which written and electronic data are difficult to retrieve and analyze. From a regulatory perspective, increasing demands are now being made on the sector to be more efficient, agile and flexible in both its product development and manufacturing operations. The project outline and scope has been discussed with FDA.

Cliff Campbell, Campbell Informatics: "The project provides a unique opportunity to deliver a world-class knowledge base in support of Manufacturing Science and Technology (MS&T). Our life science clientele will benefit greatly as a result."

As part of the project, Pharmaceutical and Biopharmaceutical plant/process/product data will be compiled by a dedicated team, on computers based both in UCC and Campbell Informatics. There will be significant interaction with industry, particularly in regard to the review and approval of the compiled standards. As a result of this participation, the resultant integrated program will enable the sector to do things more simply, logically and efficiently, sharing non-proprietary technical standards with fellow-manufacturers. This will ultimately result in more streamlined operations due to the elimination of noise and rework from the specification lifecycle. Additionally, the presence of such a repository of information in the School of Pharmacy will serve as an invaluable teaching and research asset.

Colman Casey, UCC: "This initiative is particularly timely for all participants in this rapidly evolving environment. We look forward to enhancing our interaction with industry and the regulators."

The project is led by Dr. Abina Crean, School of Pharmacy, UCC and Donagh Kiernan, Campbell Informatics.

About Campbell Informatics
Campbell Informatics, founded in 1990, delivers systems modeling and engineering data management products and services to the regulated life science manufacturing sector. The company's patented Avenio™ engine lets you define and manage process technology systems and data throughout the engineering and operational life cycles using proven Quality by Design (QbD) methodologies. Avenio flexibly integrates into current business processes, allowing for seamless migration from discontinuous engineering and compliance work practices to coordinated processes that are self-validating and self-documenting. The benefits include eliminating duplicate data, standardization of technical records, modular, front-loaded compliance, with corresponding efficiency gains and agility and flexible response to industry and regulatory changes. Campbell Informatics' professional services include agile, risk-based compliance, systems modeling, structured protocol assembly, life cycle data management, Process Analytical Technology (PAT) frameworks and technical data exchange between enterprise applications. With a blue chip client base in Ireland, Europe and USA, Campbell Informatics' solution standardizes and unifies the corporate compliance process, controls the associated master-data and stage-gates the total GEP/GMP life cycle.

About Enterprise Ireland
Enterprise Ireland is the Trade and Technology Board of the Irish Government

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Donagh Kiernan
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