GxP and Validation

Comprehensive data management solutions for regulated environments

E-WorkBook Suite offers a comprehensive, state-of-the-art application used in a wide variety of GxP environments. Providing administrator definable access control; granular audit trails; electronic signature support; integration options for digital signatures and enforceable sign off, E-WorkBook Suite fully meets the technical requirements for GxP and 21 CFR Part 11.

IDBS offers installation qualification (IQ) and operational qualification (OQ) services for its E-WorkBook Suite software implementation. Audit-ready documentation, supported by highly experienced consultants, ensures rapid and cost-effective quality assurance. IDBS also has specialized third-party validation services worldwide.

• Quality from development to deployment. IDBS' quality management system is intrinsic to our R&D process and ensures that our products and services satisfy or exceed our clients’ requirements
• IDBS is ISO 9001 and TickIT certified. Det Norske Veritas (DNV), an internationally recognized certification body, conferred IDBS' ISO 9001 and TickIT certification on 9th January 2004. ISO 9001 is an internationally accepted standard that represents good management practices and aims to ensure that organizations constantly deliver the products or services that meet clients’ requirements. TickIT is a software management standard which provides a set of guidelines and a production methodology for the design, development, production, installation and servicing of quality software
• ISO 9001 certification covers the development, testing, training, support and services associated with the supply of software products and solutions for data capture, storage and analysis primarily for life sciences, healthcare, industrial, academic and government-funded organizations.
• Certificate number: 70496-2010-AQ-GBR-UKAS
• To discuss the use of IDBS applications within a validated environment, please send an email to info@idbs.com with QUALITY in the subject line