Anselmo continued, “Embedding Reglera’s regulatory and quality IP into PTC’s PLM/QMS configurations will streamline the critical path for implementing software solutions that meet FDA’s regulatory requirements. In addition to reducing the implementation elements in the total cost of ownership (TCO), this will also have a dramatic affect on reducing cost of utilization (production use and efficiencies once implemented).” Anselmo added, “This is important, as we estimate that cost of utilization can be as much as 70% to 90% of total TCO.”
Use of PTC’s Windchill and NetRegulus Solutions with Reglera’s Existing Outsourced Solutions
With an estimated introduction of Q1 in 2010, Reglera will configure PTC’s software with Reglera’s regulatory and quality IP and offer Reglera clients a turn-key, validated, web-based, QMS solution with an outsource support option. The configured software and outsourced solution (in which Reglera resources perform assigned ongoing activities for the client) will be an additional option offered to Reglera clients. Reglera originally built and offered an industry first web-based outsourced solution in 2002. Remaining today as the only truly outsourced QMS solution in the market with numerous satisfied clients, Reglera will also continue to offer and support its original solution. Typical client internal cost reductions with Reglera’s team performing outsourcing activities are between 40% and 70%.
Anselmo concluded, “While our existing outsourced solutions meet or exceed many clients’ expectations, there are some who desire a higher level of features and capabilities. PTC’s Windchill and NetRegulus are the perfect match for delivering added value to our clients.”
About Reglera LLC
Based in Lakewood, Colorado, Reglera provides regulatory and quality assurance consulting and outsourcing services to both the medical device and human cellular tissue industries. Whether developing a new product, improving an existing product, seeking assistance with the FDA or simply trying to comply with the myriad of regulation and standards, Reglera's products and services accelerate success and profitability. With over 100 consultants, technical experts world-wide, an office in Israel and a unique offering of Quality System Outsourced Solutions, Reglera is positioned to effectively service clients from small start-ups to national and worldwide corporations. For more information regarding Reglera visit www.reglera.com or contact Tim Anschutz at 1.800.341.4255 or Email Contact.
PTC, Windchill and NetRegulus are trademarks or registered trademarks of Parametric Technology Corporation or its subsidiaries in the United States and other countries.
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