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Enterprise Security Solutions

Solutions for Healthcare and Life Sciences

Solutions for Life Sciences

Biotechnology, pharmaceutical, drug and medical manufactures regulated by the FDA need to be aware of the federal regulations surrounding the protection and privacy of consumer data, management of electronic documents and the acceptance requirements for electronic documents and signatures.

The FDA has imposed various regulations in response to soaring costs associated with managing the distribution, storage, and retrieval of records. Additionally, security concerns around hand written signatures emerged as it became increasingly evident that these signatures, including the content they were assigned to, could be easily falsified.

GlobalSign provides a wide portfolio of security solutions to enable secure document storage and distribution.

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CFR 21 Part 11 Digital Signatures

Implement CFR 21 Part 11 compliant digital signatures which provide the electronic equivalent of adding a wet ink signature to a document, assure the document recipient that the document is authentic, comes from a verified source, and the content has not been tampered with.

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Electronically Submit Records via FDA ESG


X.509 Digital Certificates are now required by the FDA for submitting electronic documentation (adverse event reports, drug files etc.) using the FDA Electronic Submissions Gateway (ESG).

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