Integrated solution supports the Secure-Access-for-Everyone (Safe) industry standard to ensure that users are who they say they are and that they are authorised to sign the appropriate documents
Scientific Software and Kyberpass announce the immediate availability of an integrated solution that provides organisations with the ability to protect and secure their intellectual property with legally-enforceable digital signatures and notarisations that support the Secure-Access-for-Everyone (Safe) industry standard.
The integrated solution incorporates the award-winning Scientific Software Enterprise Content Manager (ECM) platform for managing and archiving electronic records and the Kyberpass TrustPlatform, a security middleware solution for enabling user identity verification via a trusted third party (TTP) and public key infrastructure (PKI).
The TPP ensures that users are who they say they are and that they are authorised to sign the appropriate documents at the time of the electronic transaction.
This legally binding transaction stores the digital signature information with the electronic record, eliminating the need for wet signatures on paper documents and physical storage.
Support for the Safe Standard.
The Safe standard is promoted and funded by Safe-BioPharma, a coalition comprised of the world's leading biopharmaceutical and government organizations.
The focus of Safe-BioPharma is in defining a new digital identity standard which satisfies the mandates for the FDA's 21 CFR Part 11, EMEA and the national regulatory authorities of a number of key countries around the world.
Scientific Software has implemented support for the Safe global digital identity standard by adding the ability for users to apply Safe legally enforceable and regulatory compliant digital signatures to documents via a special plug-in accessed through the Scientific Software ECM web client.
Both Scientific Software and Kyberpass have been working directly with Safe-Biopharma and its founding members to bring this advanced functionality to market quickly.
As the biopharmaceutical industry integrates Safe into internal business applications, the integrated solution from Scientific Software and Kyberpass will simplify the end user experience for authentication and digital signature use, while reducing the cost and implementation time of Safe for IT organisations, say the companies.
The integrated solution incorporates the following software components from Scientific Software and Kyberpass:.
Scientific Software Enterprise Content Manager (ECM) - a secure content repository to manage the complete lifecycle of any electronic record type, from creation to indexing, search, collaboration, archival, retention, expiration and re-use.
Scientific Software Safe eSignature plug-in for Kyberpass - a new secure plug-in that allows end-users to electronically sign and notarise documents via the Kyberpass TrustPlatform.
This digital signature and notarisation is legally-enforceable and becomes part of the searchable and audited document index in the Scientific Software ECM repository.
Kyberpass TrustPlatform - a standards-based security framework that provides for identity verification via a seamless connection between the Scientific Software ECM repository and a standards-based (PKI) trust infrastructure.
This PKI infrastructure is typically hosted internally within the end-user organisation's local network, or can be provided via an externally-hosted, third party certificate authority (CA) signing service.
"With nine of the top ten pharmaceutical and biotech companies in the world as our customers, our Enterprise Content Manager platform has been tested and validated in some of the most stringent regulatory environments," said Soheil Saadat, president and CEO of Scientific Software.
"Through our technology partnership with Kyberpass, we're providing organisations with a solution for improved compliance that incorporates legally enforceable digital signatures to protect the integrity of their corporate knowledge assets and intellectual property".
"More and more organisations are choosing the Kyberpass TrustPlatform to help eliminate the costs of managing multiple, proprietary digital identity models and to improve alignment with corporate and regulatory security strategies," said Thomas Nolan, president and CEO of Kyberpass.
"Our integrated solution with the Scientific Software ECM platform is the first commercially available solution to help streamline document collaboration workflows and unify user identity across business-critical applications".
The integrated solution from Scientific Software and Kyberpass is shipping and available immediately.