Reglera’s 13 Years of Experience in Regulatory and Quality Consulting to Enhance PTC’s Windchill® and NetRegulus® Software Configurations with Imbedded IP to Establish
Best Practices for Faster, More Cost Effective Implementations
LAKEWOOD, Colo. — (BUSINESS WIRE) — January 15, 2010 — Reglera, LLC ( www.reglera.com), one of the world’s leading Regulatory Compliance and Quality Assurance consulting and outsourcing companies for Medical Device and Tissue Bank organizations, announced today it has become a PTC Strategic Services Partner (SSP). Reglera will offer configuration, implementation and training for PTC’s integrated Product Life Cycle (PLM) and Quality Management System (QMS) solutions sold in the Medical Device industry. PTC, based in Needham, Mass (USA), is one of the world’s top 50 largest software companies.
As a SSP, Reglera will leverage its regulatory and QMS expertise and integration / validation experience with PTC’s Windchill and NetRegulus software solutions to deliver clients industry proven best-practices PLM/QMS configurations. Having the capability to align client needs with a menu of Reglera’s “best-practice” configurations will significantly reduce implementation time and ensure clients the most cost-effective, validated solution compliant with FDA regulations 21 CFR parts 820, 1271 and 11 and applicable ISO standards.
Leveraging Reglera’s 13 Years Experience in Regulatory and Quality Consulting into PTC PLM/QMS Offerings to Reduce Clients Total Cost of Ownership (TCO)
According to Clay Anselmo, Reglera’s President and CEO, “In evaluating the Medical Device marketplace, regulated companies have consistently told us that in the arena of software/systems, one of their ongoing problems is that software companies typically utilize implementation resources with technical software knowledge but with very little, or no, regulatory compliance or quality assurance domain expertise. Without exception, this translates into long and/or failed implementations, inefficiently configured systems, increased costs, and possible quality problems leading to increased regulatory risks.”
Anselmo continued, “Having the capability to integrate Reglera’s regulatory and quality domain experience with PTC’s PLM/QMS configurations addresses clients’ needs and is valuable for all stakeholders.” Windchill and NetRegulus configurations cover all mission critical PLM/QMS elements in the profile below with the added capability of flexible and sophisticated customization and integration with other enterprise systems.
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-- Document and Change Control |
-- Supplier Quality Assurance / Purchasing Controls |
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-- CAPA (Corrective & Preventive Actions) |
-- Configuration Management |
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-- Nonconformance |
-- Employee Training |
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-- Complaints |
-- Advisory Notices and Recalls |
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-- Adverse Event Management and Filing |
-- DHR Review and Product Release |
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-- Management Review |
-- Process / Software Validation |
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-- Internal Audit |
-- Records Management |
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-- Design Control / Product Realization |
-- Equipment Maintenance and Calibration |
* Represents only a partial list of available PLM/QMS elements
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.
Contact:
Reglera
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Tim Anschutz, 303-223-4302
Email Contact