nCipher plc., a global leader in protecting critical enterprise data, has become a SAFE-BioPharma Association Vendor Partner.
This non-profit organisation was founded by the world's leading pharmaceutical companies to develop a secure means of replacing hand-signed paper based documents and forms with legally approved digitally signed documents.
The SAFE (Signatures and Authentication For Everyone) digital identity and digital signature standard delivers a legally enforceable and regulatory-compliant way to provide identity verification, non-repudiation and content integrity for electronically signed documents in the pharmaceutical industry. SAFE founder members include AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble and Sanofi-Aventis. SAFE digital signatures are already being used to make government submissions and safeguard internal documents describing research, product trials and drug discovery
nCipher's Time Stamp Server and hardware security modules (HSMs) support the SAFE standard and comply fully with the FDA's 21 CFR Part 11 Regulation. This means that pharmaceutical, healthcare and life sciences organisations can digitally sign and time stamp critical documents and electronic records using a high-strength, tamper-resistant security appliance. Not only does this overcome the inherent risks associated with software-based digital signing processes but also provides an auditable and trusted record of date and time for all submissions without relying on system clocks within host operating systems, that can be easily abused.
"We welcome nCipher as a SAFE Vendor Partner and look forward to their providing a range of time sensitive security solutions to the SAFE community," said Mollie Shields-Uehling, President and CEO SAFE-BioPharma Association.
"The importance of the SAFE security initiative is reflected by the fact that it is being driven by the world's largest pharmaceutical companies in the face of increasing competition and regulation," says Avia Dadon, product manager at nCipher. "As a SAFE Vendor Partner nCipher can apply years of experience of working with the world's largest financial institutions to meet the emerging needs of the pharmaceutical industry which represents an important vertical market sector for nCipher and opens up exciting new business opportunities."
nCipher brings a wealth of experience and leading-edge products in the area of time stamping and cryptographic key management to the pharmaceutical industry. nCipher offers the SAFE community secure systems that provide high assurance levels of the identity of the source of a signed document, the time it was signed as well as evidence that the contents have not been altered, building trust within the system and providing a mechanism for non-repudiation,
About SAFE-BioPharma Association
SAFE-BioPharma Association is the non-profit association that created and manages the SAFE digital identity and digital signature standard for the pharmaceutical and healthcare industries. Through the SAFE standard, the association promotes interoperability and integration among researchers, vendors, regulators, clinicians and other pharmaceutical and healthcare stakeholders. The SAFE standard provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions. SAFE stands for "Signatures and Authentication For Everyone." The Association's members include Amgen, AstraZeneca, Bristol-Myers Squibb, Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Organon, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis.
SAFE is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association
nCipher protects critical enterprise data for many of the world's most security-conscious organisations. Delivering solutions in the fields of identity management, data protection, enterprise key management and cryptographic hardware, nCipher enables businesses to identify who can access data, to protect data in transit and at rest, and to comply with the growing number of privacy-driven regulations. nCipher plc is listed on the London Stock Exchange (LSE:NCH).