Press release - Reston VA - June 13, 2011
BSI Group America Inc. (BSI), a leading global provider of ISO-standards-based assurance, compliance, and information solutions, is pleased to introduce Entropy Software for the healthcare industry. Entropy Software is a market-leading quality management software solution to assist organizations to deliver products to market on-time with transparency, real-time reporting, and improved quality and compliance assurance. Designed and developed to meet recognized international standards, Entropy Software provides a technology framework that allows companies to effectively manage for ISO 13485 and U.S. FDA compliance.
The web-based interface easily allows medical device manufacturers and pharmaceutical companies to remain compliant to complex regulatory requirements, improve business performance, and manage risk more effectively through a single-sourced solution. The user-friendly,customizable dashboards enhance and improve overall tracking of processes for internal and external requirements including ISO 9001, ISO 13485, 21 CFR Part 820, and 21 CFR Part 11.
In addition to streamlining operations, improving internal communications, and protecting brand reputation, Entropy Software can reduce costs related to legislation and regulatory requirements, products and services, quality control, non-conformance reporting, action planning, document control, and management review. It provides organizations with the features for an effective quality management system, as well as supporting conformance to ISO standards like 14001 for Environmental and OHSAS 18001 for Health and Safety.
“BSI is continually evolving and providing one-stop solutions to help clients get their products to market faster, while reducing overall costs and increasing internal efficiency,” said Paul Brooks, VP Healthcare Solutions with BSI. “BSI Entropy Software helps healthcare product manufacturers - both large and small, with multiple sites or just a single site – to streamline and automate their processes for enhanced compliance to ISO standards, FDA requirements, regulations, and internal policies. BSI has been a trusted partner for over 100 years with the expertise and knowledge to inspire confidence and deliver assurance to all our customers with standards-based solutions.”