Life Sciences - ePKI Solutions
Enterprise PKI for Life Sciences
Meet CFR 21 Part II electronic document requirements and ensure secure exchange of information. GlobalSign recognizes the Life Science industries are moving at a rapid pace and require tools to support the best practices and regulation surrounding the activities of key personal. Therefore, all activities performed within the ePKI managed service will be recorded and accessible in an easy to search history. Compliance officers are able to tie all significant transactions involving the management of the Digital IDs to particular administrators including the exact time and date of the transaction. ePKI can furnish the Digital IDs needed to secure your critical e-commerce applications, as well as meet the required auditing needs.
- Cost Effective – simply purchase packs starting from only $440 for 5 Digital IDs*
- Provides immediate ability to secure departmental email and electronic documents and provide authentication to public / closed networks
- Perfectly suited for the small to medium organizations or large departments wishing to pilot or start with smaller roll-outs
- Carries no set-up fees and no annual hosting fees - pay only for the Digital IDs issued
- Includes additional 10% of initial purchase in form of free Digital IDs for user attrition and/or support considerations
Life Sciences Specific Applications
As a compliance officer, CIO, or IT manager, you probably already know that applying security to a network, documents and emails falls short of your organization’s ability to comply with industry and government regulations like HIPPA and CFR 21 Part II 11. In fact applying security to produce authenticated, non-repudiated, tamper evident and often encrypted sessions is just one essential area to demonstrate your e-workflows are secure, maintainable and auditable.
For the Healthcare compliance officer, security does not stop at provisioning digital certificates, perfectly suited to meet the needs of secure electronic commerce among your key constituents - FDA, employee, contractors and partner hands. Pharmaceuticals, Biotechs and any organization involved in the drug manufacturing supply chain must also prove that those entrusted with managing electronic credentials have complete control and accountability of both new and fielded Digital IDs from issuance through renewal and sometimes revocation.
Customer Case Study - requirement to meet CFR 21 Part II 11 for Stage II clinical development electronic documents
A mid-sized San Diego based Biopharmaceutical company implemented ePKI to manage PDF Signing Digital IDs used by their scientist to exchange PDF documents including information associated with a drug in Stage II clinical development. PDF Signing for Adobe CDS meets CFR 21 Part II requirements due to the binding nature of a PKI transaction, including two-factor authentication and RFC 3161 Trusted time-stamp.
ePKI provided the appointed administrator a method to issue and manage Digital IDs to an ever changing and “virtual” work-force leading to a much quicker time to market as well as a fully compliant method of exchanging sensitive data over unsecure networks.
Replacing time-consuming paper based signature approvals with electronic “sign-offs” produced immediate savings while at the same time reducing the carbon footprint previously left by paper, courier services and other energy intensive delivery and tracking methods.
