Validation Services for Content Management Platform
Entology, a consulting organization that specializes in enterprise technology
solutions for the Global 1000, and Interwoven, a world-leading
provider of content management software for the enterprise, today announced 21
CFR Part 11 computer system validation services for the Interwoven content
management platform. "21 CFR Part 11, Electronic Records; Electronic
Signatures; Final Rule," provides guidelines that organizations must follow if
they use electronic records and electronic signature systems. Since Part 11's
inception in August of 1997, the Food and Drug Administration has required
compliance from all life science companies, and Entology's validation services
for Interwoven content management ensures that such organizations are meeting
these critical record-keeping and documentation rules and regulations.
"Validating a computing system to ensure Part 11 compliance can be a
difficult and time-consuming task, requiring a deep knowledge of the rule's
provisions and requirements," said Stephen Lombardo, director of Enterprise
Solutions at Entology. "The core purpose of validation to Part 11 standards is
to provide a high degree of assurance that a system is reliably performing
according to its requirements and specifications."
As such, validation typically requires the development of very specific
deliverables including a Validation Plan, Functional Requirement Specification
(FRS), System Design Specification (SDS), Installation Qualification (IQ),
Operational Qualification (OQ), Performance Qualification (PQ), Test Plan,
Test Scripts, Traceability Matrix, and a Validation Summary Document. Deep
knowledge of the technical platform being validated is absolutely critical for
efficiency in these tasks. By combining strong technical knowledge of the
Interwoven platform with a firm understanding of 21 CFR Part 11 requirements,
this alliance provides a single source for validated Interwoven
implementations.
Because Enterprise Content Management platforms often include electronic
records management functionality, system validation services are frequently
requested for the Interwoven platform. "We count eight of the top 10 global
pharmaceutical companies on our client roster," said Rex Thexton, vice
president of Enterprise Solutions at Entology. "We clearly understand that
compliance is one of the most critical issues facing today's pharmaceutical,
medical device, and bio-tech firms. Because we have experience delivering 21
CFR Part 11 validation services for the Interwoven platform, Interwoven and
Entology are uniquely positioned to deliver compliant Enterprise Content
Management solutions for life science organizations."
Entology and Interwoven
have been partners since 2001, and have delivered numerous content management,
portal, Web Service, and customized business solutions for mutual customers,
including Novartis, Wyeth, GlaxoSmithKline, and ACE Re-Insurance.
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