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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.
Create Trustworthy & Reliable CFR 21 Part 11
Digital Signatures
Ensure Document Security associated with managing the distribution, storage, and retrieval of records used in conjunction with the FDA (clinical trials, medical records, etc.).
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 Drug Records to the FDA
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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Meet Compliance Regulations
With identity theft and data breaches on the rise, usernames and passwords are not sufficient means of safeguarding your online services.
Implement strong two-factor authentication with granular control over which individuals and devices (including mobile) can access your online services, networks, and VPNs.
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Easily and Cost Effectively Manage Multiple Digital Certificates
GlobalSign’s managed digital certificate solutions including ePKI for client certificates and MSSL for SSL Certificates allow pharmaceutical agencies of all sizes to benefit from the security and functionality of PKI (Public Key Infrastructure) without the cost and time-to-market burden of in-house PKI Deployments. GlobalSign’s Digital Certificate Solutions are all available from one web-based platform known allowing administrators to easily manage the full lifecycle of all their digital certificates.
Have other security requirements?
View GlobalSign’s full range of PKI solutions to meet security, workflow, and budgetary requirements.
