RESEARCH NEWS

ELN compliance to 21 CFR Part 11 verified

8 August 2007



The IDBS E-WorkBook Suite’s compliance to the FDA’s 21 CFR Part 11 and Good Laboratory Practice (GLP) guidelines has been independently validated by the Sociedad de Validación de Sistemas (SVS).

The E-WorkBook has been validated against the regulations since 2006, but now the full suite, including BioBook and ChemBook, has been successfully validated.

E-WorkBook provides a secure and extensible framework within which laboratory studies can be performed, monitored, recorded, reported and archived. Through the provision of a full audit trail with version control and e-signature authentication, the system allows pharmaceutical companies to meet 21 CFR part 11’s requirements for electronic documents.

SVS provides high-value validation and compliance services to the pharmaceutical industry through its team of over 150 experts in various technical fields.

Related internet links

IDBS
Sociedad de ValidaciĆ³n de Sistemas