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One of Metastorm's customers -- a top global pharmaceutical manufacturerthat is subject to the compliance requirements of the U.S. Food and DrugAdministration (FDA) -- requested to audit the Metastorm BPM suite so that thecompany could use the software more widely within the organization. The audit,which followed GAMP 4.0 methodology, validated that Metastorm BPM providesthis customer with the functionality, process, and technical controls it needsto help comply with regulatory standards including FDA Title 21 CFR Part 11,which governs the use of electronic records and signatures to maintain thesecurity and integrity of certain types of information.
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The audit encompassed a review of Metastorm BPM and related aspectsincluding:
-- The software development life-cycle (SDLC)
-- Full traceability of business requirements, design, development,testing and release
As part of the audit and in an effort to ensure ongoing compliance,Metastorm implemented a formal Quality Management System (QMS) using the goodpractice guidelines identified by GAMP.
"Metastorm is proud to have successfully completed this rigorousevaluation which confirmed that Metastorm BPM as used by this pharmaceuticalcustomer adheres to the GAMP 4.0 guidelines," said Greg Carter, Metastorm CTOand Vice President of Development. "BPM is a logical choice for organizationsseeking to achieve compliance and governance objectives because it can enforceand manage compliance at the business process level -- most often the level atwhich an organization's compliance objectives are either met or missed. Thislatest achievement is evidence of Metastorm's dedication to being a leader inthis industry and should help to make Metastorm an important enterpriseplatform for other life sciences and pharmaceutical customers."
Metastorm continues to gain momentum as an EA, BPA and BPM vendor ofchoice for some of the world's largest and most successful life sciences andpharmaceutical organizations. For example, Wyeth uses Metastorm to help definebusiness processes and unify its information systems to break down barriersbetween organizational and geographic divisions and to improve collaborationand innovation. "Wyeth's Prescription for Business Process Management Success"was featured in the May 30, 2008 issue of CIO Magazine. The story can beviewed online at http://tinyurl.com/4yvcn5
About Metastorm Inc.
With a focus on enterprise visibility, optimization, and agility,Metastorm offers market-leading software for Enterprise Architecture (EA),Business Process Analysis (BPA) and Business Process Management (BPM). As anintegrated product portfolio, Metastorm Enterprise(TM) allows organizations toimprove business results by unifying strategy, analysis and execution.Metastorm is bringing together these critical disciplines to enable anunderstanding of enterprise architecture and strategy, accurate impact andopportunity assessment, effective process execution, and accelerated valuerealization for organizations worldwide. For more information on poweringstrategic advantage with Metastorm Enterprise, visit www.metastorm.com .-- Metastorm's HR & personnel qualifications -- Standard operating procedure (SOP) adherence -- IT & infrastructure best practices
SOURCE Metastorm
