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FOR IMMEDIATE RELEASE: Monday, October 20, 2003
Structure Networks, Inc. Launches Subsidiary; Structure Validation
Structure Validation to assist bio-pharmaceutical and drug-manufacturing industries in FDA-required systems and software validation.
TUSTIN, California - Structure Networks, Inc. (www.structurenetworks.com) today announced the launch of Structure Validation (www.structurevalidation.com), a wholly-owned subsidiary serving the bio-pharmaceutical and drug-manufacturing industries in FDA-required systems and software validation.
The pharmaceutical industry is increasingly using electronic information systems to improve efficiency of operations. One of the major initiatives is to move to a paperless environment and thereby significantly reduce costs. At the same time, major forces based on market demands and regulations, are calling for developing enhanced security policies and practices in order to protect electronic information. Structure Validation will focus providing Consultants with expertise in Title 21 Code of Federal Regulations (CFR) Part 11 which establishes the requirements for electronic records and electronic signatures to be considered trustworthy, reliable and essentially equivalent to paper records and handwritten signatures executed on paper. This rule applies to any records, covered by FDA regulations, that exist in an electronic format - including those records that are required to be maintained whether they are submitted to the FDA or not. In addition, FDA validation is required for any system or software application used for manufacturing, labeling, packaging, or distribution of drugs.
"Structure Validation is a direct result of customers asking us to provide these consulting and staffing services. Over the past two years, our healthcare and bio-pharma practices have grown dramatically and it was a natural move for us. We felt that creating a separate company to address these requirements was essential" said Alex Salottolo, President and Founder of Structure Networks, Inc. "Due to the tremendous amount of services industry consolidation over the last 7 to 8 years, there has been a dramatic drop in service and niche know-how across the board. This new subsidiary will provide the service levels and expertise that has become extremely difficult to find in recent years" he went on to say.
With offices in Southern California and the Bay Area, Structure Validation will initially focus on providing staffing and consulting services to West-coast based bio-pharma and drug manufacturing clients.
About Structure Validation Structure Validation is a a wholly-owned subsidiary of Structure Networks, Inc., a privately-held consulting firm headquartered in Tustin, California (Orange County). Founded in 2003, Structure Validation, a business unit within Structure Networks, Inc., is focused on validation and quality systems serving the pharmaceutical, biotechnology, and medical device industries. Structure Networks focuses on network-centric technologies, applications development, testing, ERP, and general IT Consulting and Staff Augmentation Services.
For additional information, please contact Dave Thomas at dave@structurenetworks.com. Please visit us at www.structurenetworks.com or www.structurevalidation.com |