The move to comply with the FDA's 21 CFR Part 11 by players in thepharmaceutical, biological and medical equipment industries, has seen a migration to electronic systems and a concurrent demand for digital signature solutions. With the transformation from paper to electronic documents, players in the pharmaceutical, biological and medical equipment industries are mandatedto use digital signatures. In addition, by eliminating the requirement to printthe paper forms for authorization, Life Sciences companies can dramatically save operational costs and shorten processing cycle time. This leads tobenefits in areas such as paperwork reduction (as documents are signed electronically they no longer have to be printed) and the protection of intellectual property.
Typical uses for Electronic Signatures in Life Sciences
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R&D
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Clinical development
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Regulatory affairs
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Manufacturing
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Marketing, sales, and more
Benefits of Digital Signatures for Life Sciences
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Never have to question the authenticity of records or the identity of the signer
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Eliminate the risk of data theft and forgery
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Add both digital and graphical (wet) signatures to a document
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Meet regulatory compliance
Life Sciences Regulations & Digital Signatures
Compliance with 21 CFR Part 11 and achieving GxP, Computer System Validation, internal SOPs, and new regulations such as SOX, HIPAA, or future industry standards such as SAFE Bio-Pharma with proven technology in these applications.Electronic signatures based on a mature & proven PKI (Public Key Infrastructure) technology are the best means to protect the integrity of information. And indeed these regulations require the protection of integrity “to corroborate that electronic protected information has not been altered or destroyed in an unauthorized manner”.