With the responsibility to provide safe products to consumers, the industry that operates in the segments focused on Life Sciences follows strict rules. To meet effectively the demands of such rules, all areas of the company, including the design, manufacturing and distribution, must meet the requirements such as ISO 9000:2005, ISO 9001, ISO 13485, ISO 14971, ISO/IEC 17025, ISO/TR 10017:2005 GxP, QSR Title 21 Part 820 and 21 CFR Part 11. Compliance with laws and regulations require a great effort on the part of businesses, in order to ensure not only to meet the standards, but also implement continuous improvement and security in their products.
Our software suites for Quality Management of Life Sciences Industry, enables the fulfilment of all these requirements, since the safety of the product, risk control and suppliers, until regulations and recalls as eliminating ineffective methods of control (spreadsheets) and providing reliable data with agility and security.
A complete solution that helps taking actions needed to reduce risks and waste, reducing costs and boosting competitiveness.