CoSign Digital Signatures for Life Sciences

Strict regulations, such as the FDA's 21 CFR part 11, require organizations in the life sciences industry to guarantee the authenticity, integrity and confidentiality of electronic records. In addition, these organizations require a highly collaborative ecosystem, demanding optimal communication and workflow processes in order to compete and succeed. The time-consuming and labor-intensive characteristics associated with paper-based processes simply do not allow these organizations to maintain the competitive edge they need to remain compliant and be successful.

Digital signature solutions produce legally enforceable electronic records, closing the gap in going fully paperless by completely eliminating the need to print documents for signing. Digital signatures enable the replacement of slow and expensive paper-based approval processes with fast, low-cost, and fully digital ones.

By enabling a fully automated workflow, digital signatures reduce the expenses and time allocations that paper-based signatures require. A paper-based signature is estimated to cost an organization upwards of $5.40 each (including printing, scanning, archiving, routing and replacing lost documents). An average authorized signer signs two documents a workday. With 20 workdays a month, the monthly paper signing costs can surpass $100 per signer.

By ensuring compliance with the FDA's 21 CFR part 11 (as well as GxP audits, HIPAA, SOX, and  ISO) and reducing the costs and time associated with signature authorizations, digital signatures are a standard in the life sciences industry. Via its standards-based underpinnings, the CoSign® digital signature solution is able to create a truly collaborative environment for the multiple parties involved in the life sciences ecosystem, expediting approvals spanning geographic locations or even multiple organizations. Additionally, CoSign's ability to remove the costs and time constraints associated with paper-based approvals significantly increases organizational efficiency. Read more about the digital signature business case for the life sciences industry.

Learn more about the use of digital signatures within various life science operations and applications:

GCP clinical operations:

• Clinical Research Organizations (CROs)
• CTMS, Investigator Portals and Trial Master Files
• Clinical Service Organizations (CSOs)
• Sponsors - BioPharmas and Medical Device Companies

GLP lab operations:

• Contract Central Labs

cGMP manufacturing operations:

• Contract Manufacturing Organizations (CMOs) and Pharmaceutical Manufacturing
• Medical Device Engineering, Manufacturing and Service Operations

As well as non-regulated operations including pre-clinical Research & Discovery such as Electronic Lab Notebooks.

CoSign works seamlessly with all common document formats such as Microsoft® Word, Excel®, Outlook®, InfoPath®, Adobe® PDF, AutoCAD®, Bentley® MicroStation, TIFF, and other document types. CoSign is standards-based (based on Public Key Infrastructure – PKI), avoiding vendor lock-in and allowing the document to be verified by anyone, anywhere, anytime without the need for proprietary verification software or third party support.

CoSign is offered in two versions – CoSign Desktop is meant for individual users, while CoSign Central is designed for a multiple-user organization. CoSign Central is based on easy-to-use software that communicates with a centralized and secure digital signature server. It is quick-to-deploy and ideal for mid to large sized organizations, offering seamless integration with content management and workflow systems. For smaller organizations (up to 10 signers), CoSign Desktop is offered as a standalone solution that does not require any hardware component. Learn more about the differences between CoSign Central and CoSign Desktop.

By ensuring compliance with FDA regulations such as 21CFR Part 11 and GxP audits, as well as HIPAA, SOX, and ISO, the CoSign digital signature solution is an ideal signing solution for organizations in the life sciences industry.

Continue reading about CoSign's FDA regulatory compliance.

CoSign is the largest and most widely-deployed digital signature solution in the FDA and HIPAA-regulated industries. CoSign's life science clients consist of over 20,000 FDA-regulated organizations including: 6 of the top 10 CROs and over 35 CROs throughout  the world, Over 10,000 CRAs, over 10,000 investigator sites and IRBs, 8 of the top 10 BioPharmas, 5 of the top 10 Medical Device companies, over 50 central labs and many more. Some of CoSign’s life sciences customers include:

The digitally signed electronic records created by CoSign have been used to support thousands of successful FDA, USDA, HIPAA, HACCP, SOX and ISO audits. Read about CoSign's customers in the life sciences industry.