IDBS has announced that its complete E-WorkBook Suite has been independently validated by the Sociedad de Validacion de Sistemas (SVS) against the FDA’s 21 CFR Part 11 and Good Laboratory Practice (GLP) guidelines.
E-WorkBook has been validated against the regulations since 2006 and now the full E-WorkBook Suite, including BioBook and ChemBook, has been successfully validated.
SVS is a validation and compliance consulting company based in Spain. Founded in 1994, SVS provides high-value validation and compliance services to the pharmaceutical industry through its team of over 150 experts in various technical fields.
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.
“We are proud to be the independent validation partner for IDBS,” commented Pierenrico Bonalumi, Computerized Systems Validation Manager of SVS. “Through its ability to enforce a process and meet the technical requirements of 21 CFR part 11, the E-WorkBook Suite can help organizations achieve regulatory compliance.”
Neil Kipling, founder and CEO of IDBS commented, “Pharmaceutical companies need robust and secure ELN systems to protect intellectual property (IP), comply with 21 CFR part 11 regulations and ensure good laboratory practice”. He added, “SVS have shown that IDBS’ E-WorkBook Suite can be successfully validated against 21 CFR part 11 and GLP in pharmaceutical companies.”