By Rodd Schlerf.
By using digital signatures to eliminate paper from signature approval processes, pharmaceutical companies are achieving automated processes that are efficient and cost-effective without compromising security or compliance. With improved IT infrastructure, the advent of cloud computing and the focus on business process automation and time-to-market, many modern day businesses are spelling the end for ‘wet ink’ signatures.
The European Medicines Agency (EMA) recently announced its acceptance of digitally signed pdf forms for Scientific Advice, Orphan Medicines and Paediatric submissions. The EMA’s acceptance of digital signatures that comply with EU regulations follows the standards set forth by bodies including the National Institute of Standards and Technology and the European Telecommunications Standards Institute, whose standards facilitate secure paper-free business transactions in conformance with European legislation. This means that digital signature adopters can bypass the costly, time-consuming and environmentally damaging “print-sign-scan” process, and minimize the cost and burden of physically archiving legally enforceable documents.
Using standards-based technology, digital signatures (as opposed to simple electronic signatures, e.g. bit-map images) are legally enforceable and fully secure. The signer’s identity and the document’s integrity are maintained regardless of where the document is sent or stored, supporting compliance with a raft of international standards and regulations. With clinical trials this can make fundamental difference to a project’s overall complexity and completion time. To comply with the FDA’s 21 CFR Part 11, each of the many documents within a clinical trial requires legally enforceable signatures, often from multiple people who may be geographically dispersed. With ‘wet ink’ signatures, the time and costs associated with printing and routing these signed documents are profound.
With fewer new drugs being approved each year, pharma must look to internal efficiencies to improve margins, and considerable time and effort is being spent on improving, securing and automating business processes. Not only that — consider that many organizations print out roughly half of all documents just for the sake of getting them signed. This is time-consuming, labour-intensive, inefficient and expensive, not to mention the environment damage. In the UK alone, 80.6 million tons of office paper is thrown away each year.
Rodd Schlerf is FDA Markets Manager, ARX.