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Taigle, SAFE-BioPharma partner

Friday, December 6, 2013

Taigle, an Irvine, Calif.-based technology company, has partnered with the SAFE-BioPharma Association, which manages the global SAFE-BioPharma digital identity and signature standard. 

SAFE-BioPharma Association members include Pfizer, GlaxoSmithKline, Merck, Sanofi, Bristol-Myers Squibb, AstraZeneca, Eli Lilly and Roche.  

Taigle plans to expand use of its cloud-based MySignatureBook (MSB) digital signing solution in the life sciences. The SAFE-BioPharma standard is used by the biopharmaceutical and healthcare sectors to assure high trust in cyber-identities and to enable secure paperless transactions. MSB supports the SAFE-BioPharma standard.

MSB automates and controls the entire document signing process, replacing manual signatures with highly efficient, and legal and regulatory compliant digital signatures. Organizations using MSB experience reduced costs and speedier transactions.

“Unlike other signing engines, MSB is highly attuned to FDA and other regulatory agency requirements. This capability, combined with integration of the SAFE-BioPharma standard, makes MSB ideal for use by biopharmaceutical and healthcare companies,” said Ajit Sodhi, president and chief technology officer, Taigle.

MSB integrates easily with existing enterprise applications, including electronic laboratory notebooks and those used in Healthcare Information Exchanges. It is used to upload documents, define signing policies, request signatures, notify document custodians and signatories and download the signed documents.

The two organizations collaborated previously, when MSB was the cloud-based digital signing engine that facilitated the fully paperless clinical trial start-up phase of a cancer research study involving scientists at the National Cancer Institute and their counterparts at two pharmaceutical companies. The public and private sector scientists were able to access cloud-located documents and review, exchange, and sign them using interoperable digital identity credentials—company scientists using credentials based on the SAFE-BioPharma standard; NCI scientists using credentials based on a compatible U.S. government system.

Any electronic document signed with a SAFE-BioPharma digital signature is non-repudiable; the signatory cannot deny having signed it. Additionally, any change to a signed document graphically invalidates the signature, a feature that lasts for the life of the document. The document may be stored for decades.

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