SIGNiX, a digital signature vendor, will partner with SAFE-BioPharma Association to provide a self-contained digital signature service compliant with the global SAFE-BioPharma signature standard. The service will allow healthcare and other regulated organizations to quickly and easily start a complete cloud-based digital signature product. SAFE-BioPharma is the nonprofit industry coalition responsible for the ongoing development and implementation of the global SAFE-BioPharma digital identity and signature standard.
In the past, healthcare companies had to piece together a document workflow product and a digital certificate product to create a process that complied with the SAFE-BioPharma standard. Using SIGNiX's advanced web services API, healthcare companies will be able to easily integrate the digital signature product into their existing systems of record.
The SAFE-BioPharma standard supports highly secure digital signatures. Digital signatures differ from conventional e-signatures in that they are uniquely linked to and are capable of identifying the signatory. They are created using data that the signatory can use under his/her sole control with a high level of confidence, and they are linked to the signed document in such a way that subsequent change in the document is detectable.
Importantly, digital signatures compliant with the SAFE-BioPharma standard meet these criteria and are legally binding. They are used on electronic documents throughout the biopharmaceutical and healthcare industries, including, among others, regulatory submissions, clinical trial documents, laboratory notebooks and contracts. The U.S. Drug Enforcement Agency requires digital signatures on ePrescriptions for controlled substances, and the EMA requires them on certain submissions and uses them to sign outgoing documents requiring a legally binding signature.