Evolution Scientific (ESi), a technical service provider to the pharmaceutical, biotech, medical device and other regulated industries, has joined SAFE-BioPharma Association, the nonprofit industry coalition responsible for the ongoing development and implementation of the SAFE-BioPharma digital identity and signature standard.
As a member, ESi is able to utilize the SAFE-BioPharma standard throughout its operations. It is the first comprehensive technical service provider to become a SAFE-BioPharma member.
Adhering to strict standards for quality management systems, ESi provides personnel to measure and monitor the multitude of devices used in manufacturing, research and other areas of the life sciences. Based in Doylestown, Pa., it operates in North America, China, Japan and the E.U.
"As a SAFE-BioPharma member, we plan to apply digital signatures to the thousands of electronic reports and other documentation our technical staff produces each month. It will help us and our clients reduce paper, and with that, costs," said Joseph Morwald, CEO, Evolution Scientific. The reports are required by the companies to meet auditing and regulatory requirements.
Digital identity credentials compliant with the SAFE-BioPharma standard are used to manage cyber-identities in the biopharmaceutical and healthcare sectors and to apply digital signatures to electronic documents. Unlike common electronic signatures, SAFE-BioPharma digital signatures are tightly bound to the signatory's proven identity. They are traceable, legally binding and cannot be denied in a court of law. SAFE-BioPharma digital identities are interoperable with U.S. federal agencies, meaning they will be trusted across firewalls. Digital signatures consistent with SAFE-BioPharma criteria are now required on certain submissions to the EMA and used by EMA for all correspondence requiring legally binding signatures.