CoSign Digital Signatures for Life Sciences - Business Case

Digital signatures enable the replacement of slow, expensive, and non-productive paper-based approval, collaboration, and delivery processes with fast, low-cost, and efficient digital operations. This results in:

• A tangible Return On Investment (ROI) that offers a typical payback period in the 3-6 month range.
• Decreased costs associated with reducing people's time spent on non-productive clerical activities, plus the hard cost savings by eliminating paper based processes (paper, printing, copying, signing, processing, routing, faxing, mailing, microfilming, indexing, storing, retrieving, shredding, etc). Industry averages puts these average cost at $18-20/document minimum.
• Increased efficiencies, speeding up approvals and the time to approve the documents, forms, reports, data, etc., particularly for documents requiring multiple approvals where the signers may span geographic locations or even multiple organizations.
• Improved quality and compliance by enforcing best practices and the integrity of records.  This is what SOX, HIPAA and FDA regulations are emphasizing today, requiring proof of signer ID/intent plus guarantee of data integrity. With CoSign, audits are more efficient and less expensive through a consistent and controlled electronic process.
• Facilitated collaboration by bridging the geographic, technical, and corporate boundaries with outside parties such as the government, clients, suppliers, partners, etc.  Outside parties can readily trust and verify electronic records, submission and secure document exchanges, or even be given the ability to sign required documentation.

CoSign reduces costs, speeds operations, improves quality and security, and enables collaboration and control throughout the internal/external ecosystem the life science organizations operate in everyday.

Digital Signatures can automate your signature-based approvals affordably, allowing you to go paperless, cut costs, and expedite business processes. CoSign digital signatures are particularly beneficial for:

• Internal regulated operations
• External-facing applications
• Internal non-regulated enterprise applications.

Internal Regulated Operations

CoSign installations include use for regulatory and quality departments and core operations in R&D, clinical, lab, and commercial manufacturing. 

Documentation being signed by CoSign includes: SOPs and work instructions, training records, project and task specific documentation, specifications and requirements documentation, test procedures, electronic lab notebooks, clinical monitoring trip reports, clinical reports, manufacturing instructions, electronic batch records, certificates of analysis and other labs reports, project spreadsheets, field service reports and maintenance/calibration reports, validation documentation, electronic medical records, etc.

In many cases CoSign is being used to sign documentation on the user’s desktop PC, but in other cases CoSign is fully integrated with a business application such as an ERP or electronic document management/workflow (EDM) system. CoSign has been integrated with leading ERP and EDM systems from suppliers such as SAP, Microsoft (SharePoint), NextDocs, OpenText (LiveLink, Hummingbird eDocs), IBM (SCORE, FileNet), Adobe (LiveCycle), Oracle (Fusion Middleware Content DB, Stellent UCM), Xerox (DocuShare), Laserfiche, as well as custom applications and workflow systems such as Nintex or K2.

External-Facing Applications

CoSign is an ideal solution for web-based B2B/C applications where a company hosts the solution, enabling external parties to sign documents.  

Some of the largest hosted digital signature services for external signers deployed today are using CoSign. For example:

• In the regulated clinical trial market, companies like Kendle, eTrials, PAREXEL, ClinPhone, Datalabs, EntraLogix, ePharma Solutions, PhaseForward, NextDocs, CSG and RMC Pharma all host CoSign for external users to sign FDA clinical documentation. These services are usually referred to as Clinical Trial Management Systems (CTMS), Investigator Portals, or Trial Master Folders. CROs, sponsors, investigators, IRBs, and labs use CoSign to digitally sign documentation such as CDAs, 1572s, financial disclosures, informed consents, protocols, clinical trial agreements, CVs, IRB approvals, authorizations to handle or ship, and other licenses, certifications and references.
• In the veterinary health space, GlobalVetLink hosts CoSign for thousands of doctors of veterinary medicine (DVM) to sign FDA, USDA, Health Canada and Canadian Food Inspection Agency regulated forms. 
• In the healthcare market, eWebHealth hosts a CoSign system for their web-based HIPAA-regulated Electronic Medical Record SaaS which supports tens of thousands of physicians signing millions of medical records annually. 
• And in the government markets, MAXIMUS hosts a large service for over 500,000 external clients to sign off on Department of Homeland Security documents every year.

Internal Non-[FDA] Regulated Enterprise Applications

For everyday non-regulated applications throughout the enterprise, CoSign is being used in HR, Finance, Purchasing, Legal and Contracts, Sales, and Marketing departments for secure approvals and signature requirements meeting internal and government needs such as ISO, HIPAA, SOX, etc. 

Regulated

• Standard Operating Procedures and work instructions
• Training records
• Project and task specific documentation
• Specifications and requirements docs
• Test procedures
• Electronic lab notebooks

Non-Regulated

• POS and capital appropriation requests
• AP/AR and invoices
• New hire documents, annual forms, and employee evaluations
• Contracts and agreements

By demanding engineers to spend valuable time on printing, manually signing, and routing documents, paper-based signatures incur organizational costs, and cause delays and inefficiencies. It is estimated that each paper signature costs an organization $5.40 in associated expenses (i.e. paper, printing, signing, scanning, routing, archiving and replacing lost documents;  Pfizer estimates this cost at $30). Based on actual log data of ARX's customers, the average authorized signer signs over 250 documents per year, bringing the annual paper-based costs per signer to over $1,350. This figure is much higher for organizations with multiple locations and/or field staff that need to submit formal reports or contracts.

The CoSign digital signature solution eliminates these costs through a simple, scalable and quick-to-deploy solution. CoSign makes it easy to digitally sign all standard file formats by embedding the digital signature directly into the document and sealing it from change. CoSign digital signatures enable regulatory compliance, and support graphical signatures and multiple signatures per document.

Calculate the return on investment of implementing digital signatures in your organization by downloading our digital signature ROI whitepaper and Excel spreadsheet.