April 18, 2007 — /PRNewswire/ — CORK, IRELAND — Campbell Informatics and PIC Consulting (PIC) announced today that PIC will use the AvenioTM engine and methodologies as its preferred design, validation, standardization and quality engineering process control solution for engineering design and C&Q projects in global pharmaceutical and biotech firms.
“PIC envisage that Avenio will be the central point of access for all plant and engineering related data representing significant cost savings and operating efficiencies,” said Marc Willems, Managing Director, PIC Consulting. “The powerful capabilities behind the Avenio engine deliver a new and ingenious form of data access, process control and right-first-time philosophy.”
The Avenio system was chosen by PIC Consulting on its ability to model data based on the customers’ commissioning, validation master plan and process validation documentation requirements. The Avenio philosophy that validation should be data-driven and that facilities and processes must be identified and characterized before they can be verified were key factors in the decision to adopt Avenio in terms of structuring a plant’s engineering design strategy.
“This licensing deal marks an extension of the relationship between PIC Consulting and Campbell Informatics,” said Donagh Kiernan, CEO of Campbell Informatics. “By broadening the existing relationship between the two companies, PIC’s European pharmaceutical and biotechnology clients can further benefit from data standardization, data re-use, supporting the design process and auto-generating C&Q documentation.”
Campbell Informatics’ patented AvenioTM engine allows for the definition and management of 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.
About PIC Consulting
PIC Consulting (PIC) delivers consulting, engineering and validation services to the European pharmaceutical and biotechnology industry specialized on aseptic and mono-septic applications. As a mid size consulting company PIC is following a “specialized – innovative – individual” strategy targeting mid size projects of the industry. Together with its various partner companies, PIC is able to cover full project life cycle services from early consulting to validation including a broad range of measurement services and the delivery of skid mounted process units. PIC Consulting was founded in 2004 and is based in Heidelberg, Germany; Pardubice, Czech Republic; and Monthey, Switzerland. Further information: www.pic-ger.com
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 AvenioTM 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. www.campbellinformatics.com
Source: Campbell Informatics
Contact:
Donagh Kiernan of Campbell Informatics
+353-21-4291336 [email protected]