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Fort Collins, CO, United States, 2007/01/29 - Another Solution from the FastTrak™ Family Supporting Product Lifecycle Management and Quality Solutions in the Medical Device Industry.
Integware, a leading provider of Product Lifecycle Management (PLM) consulting and implementation services, knows all too well what a solid CAPA system can do for a medical device company. “Through our consulting work for a number of leading medical device companies, all say the same thing, our biggest pain point is managing our CAPA’s, so we decided to do something about it” said Chris Kay, CEO of Integware.
FastTrak™ CAPA can be purchased as a single module or as a bundle with other FastTrak™ products (FastTrak™ NCR, FastTrak™ Change, FastTrak Med Device™). Whatever the need, Integware delivers proven, integrated best-in-class PLM-based solutions designed for your company’s specific product lifecycle processes. “To support process excellence initiatives, the CAPA process needs to interact with all aspects of product development, from design through manufacturing to support.” said Max Huff, Senior Consultant. Integware provides the only CAPA solution with process integration capabilities beyond just the quality organization to meet the needs of FDA regulated companies.
Integware’s FastTrak™ CAPA allows for integration with other Quality Management Solutions (such as FastTrak™ NCR, Change, Complaints, Quality Audits, Verification and Validation and BOM Configurator) and all other PLM solutions within the FastTrak™ suite. This system promotes the adoption of the preventive mind-set. “Companies are now able to move toward taking preventive actions vs. just correcting issues that have already happened” said Chris Kay.
Integware’s FastTrak™ CAPA is currently in global production for several leading medical device manufacturers. FastTrak™ CAPA is the result of years of providing CAPA and many other compliance and product lifecycle solutions to leading medical device companies around the world. This powerful solution enables organizations to manage the CAPA process across the entire company, helping you meet FDA regulatory requirements, increase efficiency and reduce costs. Each FastTrak™ solution comes complete with documentation, training and validation, making your investment painless for your organization.
About Integware, Inc.
Integware (integware.com) is a recognized leader in helping Life Science companies accelerate innovation, automate compliance, reduce product development costs and deliver strategic business results. Our rich history and trusted client relationships with major medical device companies has empowered us to pair an unmatched understanding of our clients’ business issues with an outstanding level of competence in addressing them effectively and efficiently. Quality and innovation are the keys to remaining competitive, compliant and avoiding costly adverse events such as recalls. By merging product process and domain knowledge together into integrated PLM platforms, Integware provides the prescription for digital compliance.
FastTrak™ CAPA is a registered trademark of Integware, Inc.