Electronic Signatures in Pharmaceutical

ARX Electronic Signature Solution -
Increasing efficiencies and ensuring data integrity

The solution is in the process

In an era of digital technology, when automation of processes drives productivity and reduces costs, the pharmaceutical industry still generates mountains of paperwork. These paper processes can result in liability concerns and difficulty in controlling and monitoring changes, updates, and approvals. Manually signing these documents is a long process that can take days to complete, thereby significantly hindering pharmaceutical processes.

CoSign® helps pharmaceutical companies comply with 21 CFR, Part 11

In a competitive environment, accelerating processes is essential. Being first to introduce new drugs to market is worth millions and therefore life-science organizations must be quick and efficient. However, being quick is not enough. For pharmaceutical companies to become paperless they require compliance with regulations such as 21 CFR (Code of Federal Regulations) Part 11, the Food and Drug Administration's regulations on electronic record keeping and electronic signatures. Companies undergo continuous auditing by external parties such as the FDA, which mandates evidence that their data is valid and their processes are well defined.

It's time to replace traditional signing methods with CoSign

CoSign, the innovative and non-forgeable electronic signature solution ensures data liability and enables organization to comply with regulations worldwide. It also allows organizations to significantly shorten process’s cycle times and expedite delivery to market.

So what does the FDA require?

In order to migrate to more efficient electronic systems, pharmaceutical organizations must comply with 21 CFR Part 11 specific requirements, which mandate that companies implement:

Systems and processes such as drug approval, quality assurance, Standard Operating Procedures (SOP’s) and client submissions can significantly benefit from electronic signatures. This is because they pose the utmost risk in terms of product quality and/or public safety. These systems require constant monitoring, updating and reviewing. By implementing electronic signatures into their system, pharmaceutical organizations can benefit from a convenient method of monitoring changes. In addition, authorizations and updates have a clear electronic audit trail for the transaction.

CoSign brings convenience and compliance to Pharmaceutical processes

Up until now electronic signatures have been a complicated and expensive solution to integrate and manage. Today, ARX has developed a electronicsignature solution that is simple-to-use, secure and cost-effective. The life science industry will greatly benefit from the use of electronic signatures in terms of efficiency and data integrity. With CoSign, organizations will be able to electronically sign, as well as send and archive electronic records, whilst complying with FDA regulations.

Simplicity and Security of CoSign

CoSign proves an innovative and a trustworthy way to electronically sign documents and transactions. Implementing CoSign’s PKI based technology guarantees that your signature cannot be copied or tampered. CoSign is easily integrated with in a growing number of applications such as Microsft® Word, Adobe-Acrobat and leading document management systems. In addition, CoSign is the only electronic signature solution that signs scanned TIFF images. It can be smoothly deployed within any organization's existing user-management systems. CoSign delivers a zero management and reliable way of implementing electronic signatures within major application. Therefore, by implementing this solution pharmaceutical companies that are already migrating to paperless solutions such as content management systems and workflow applications can now eliminate the last paper in their organization. It also enables users to easily verify the validity of the signature anywhere, anytime.

ARX Electronic signature solution

CoSign provides standards that conform and exceed the 21 CFR Part 11, electronic signature requirements as well as provide added value offerings that enables organizations to streamline time consuming paper-based processes, these include:

So no more waving pens from one another

CoSign allows pharmaceutical companies to easily migrate to a secure and convenient electronic working environment that ensures data integrity and non-repudiation of documents. CoSign is the electronic signature solution that enables immediate compliance with FDA regulations.

Considering CoSign’s technology pharmaceutical companies can significantly become more efficient and productive. Pharmaceutical organizations, CRO’s, biological and medical equipment industries can now dramatically save operational costs, expedite delivery, by eliminating the requirement to print the paper forms which in turn helps gain competitive advantage.