BSI introduces Entropy® software for healthcare product manufacturers

Press release - 13 June 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.”

Entropy is a web-based software solution providing a technology framework that allows companies to effectively manage Governance, Risk and Compliance (GRC). Entropy helps businesses continuously improve control, assurance, and accountability; reduce risks, incidents, liability, and cost; and protect and enhance brand value and reputation. Designed and developed to meet recognized international standards, Entropy provides a risk management and compliance system that is certifiable and auditable against the requirements of the ISO Standards. Entropy is in use at over 50,000 sites worldwide to address companies' risk, compliance, and performance management in areas of corporate governance, corporate social responsibility, environmental, health & safety, quality, and supply chain compliance management. For more details on Entropy solutions visit

About BSI Group

BSI Group is a global independent business services organization which enables businesses, governments and other organizations to increase profits and market access, and to enhance reputation with its standards-based solutions and assurance services. From its origins as the world’s first National Standards Body, BSI Group draws upon over 100 years’ experience to partner with 66,000 organizations in 147 countries from its 50 offices. Today, through its independence, innovation and integrity, BSI continues to improve the lives of millions by raising standards worldwide. To learn more about BSI Group, please visit

Media information

Shereen Abuzobaa

Vice President Marketing & Training

BSI Group America Inc.

Reston, VA, USA