Electronic records/signatures acceptance

All LIMS functions (e.g., manual data entry, automated data entry, and report generation) should be assessed to evaluate the effect that they could have on the data that will support regulatory submissions and release of product to market. This approach must be methodical to ensure that relevant functionality is not overlooked. It is essential, for instance, that Business Continuity Plans are verified as being appropriate and workable. This testing should cover all aspects of the recovery process from the loss of individual components (e.g., an analytical instrument interface) to the full loss of LIMS (e.g., representing a catastrophic failure of the LIMS server). The criticality of the data associated with the management of Electronic Records and Electronic Signatures should also be a focal point. However, it must be accepted that these assessments can be subjective and therefore they rely heavily on the experience of the assessors. 

CRF, Part 11, permits but does not require the use of electronic records and signatures. As more systems become validated and accepted, and as more... 

Until recently, paperless manufacturing operations were held back in the pharmaceutical industry because the U.S. Food and Drug Administration (FDA) did not accept electronic signatures. This obstacle was formally removed when the U.S. GMPs (Good Manufacturing Practices) were enhanced to accept electronic records and signatures under specified conditions by... 

Will not be acceptable for records with electronic signatures. 

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