Digital Signatures for Life Sciences Fact Sheet

CoSign® makes it easy for life science organizations to digitally sign transactions, documents, forms, etc., by embedding standard (PKI-based) signatures directly into common files and business applications. CoSign produces a 21 CFR part 11 compliant electronic signature record for every approval, and allows easy and secure validation and proof of signer identity, intent, and document integrity without any costly, complex, or proprietary technology required for verification.  

The results are digitally signed electronic records that are portable and sustainable throughout a pharmaceutical or medical device ecosystem, including internal employees and external partners, suppliers, clients and even regulators that need to trust documentation in an electronic format.

• Decreased Costs. This includes people’s time as well as the hard costs of paper processes – paper, printing, copying, signing, scanning, processing, routing, faxing, mailing, microfilming, indexing, storing, shredding, etc. Industry averages put this cost at $18-20/document.
• Increased Efficiencies. CoSign accelerates the pace of approvals particularly for documents requiring multiple signatures across multiple geographies.
• Increased Quality. In addition to SOX, HIPAA and FDA regulation compliance and enforced best practice policies, CoSign also provides guaranteed signer identity, intent, and proof of data integrity.
• Increased Collaboration. CoSign enables trust, bridging the geographic, technical, and corporate boundaries, including communication gaps with outside parties such as the government, clients, suppliers, partners, etc. throughout an extended value chain or ecosystem.

CoSign keeps your business moving – including clinical study sponsors, sites, CROs, IRBs, laboratories, CMOs, SaaS vendors, software and service suppliers, etc. - by fully automating workflows and quickly scaling processes at a low cost with proper controls.

With CoSign, you can be assured that you will be using the simplest, most widely deployed and cost effective solution for the widest range of applications and business processes requiring approvals and security.

• Thousands of FDA GxP regulated applications use CoSign today
• Tens of thousands of healthcare professionals use CoSign for HIPAA compliant EMR
• Electronic records signed by CoSign have supported thousands of FDA, HACCP, USDA, EMEA, HIPAA, SOX and ISO audits
• FDA regulated clients include:
• 9 of the top 10 Pharmaceutical and 5 of the top 10 Medical Device companies
• 6 of the top 10 largest CROs
• 50+ contract central labs
• Many of the leading service, SaaS and software providers of EDM, EDC, CDMS, IVRS, EPRO etc., including many of the leading CTMS (clinical investigator portals and trial master file).