Reglera Becomes a PTC Strategic Service Partner for the Regulated Life Sciences/Medical Device Industry

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.

-- Document and Change Control

       

-- Supplier Quality Assurance / Purchasing Controls

-- CAPA (Corrective & Preventive Actions)

-- Configuration Management

-- Nonconformance

-- Employee Training

-- Complaints

-- Advisory Notices and Recalls

-- Adverse Event Management and Filing

-- DHR Review and Product Release

-- Management Review

-- Process / Software Validation

-- Internal Audit

-- Records Management

-- Design Control / Product Realization

-- Equipment Maintenance and Calibration

* Represents only a partial list of available PLM/QMS elements

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