Even though digital approvals in email or even text messages are enough to get things done day to day for many companies, you still can’t buy a car or a house or authorize a legal document without a good old wet signature. Your ‘John Hancock’ is unique to you, and legally, it’s your mark of authenticity. Signatures still function in two ways: to verify that we are who we claim to be and as evidence that we did something in the past. For regulated industries, this translates to authenticating a person’s identity as well as providing evidence in an audit trail as to the actions and decisions that person made.
How do pharmaceutical manufacturers operate with a ‘signature’ level of authenticity and still get things done at the rate of speed required to compete in a heated global marketplace?
Across the globe, companies are increasingly relying on electronic records and electronic signatures to increase efficiency and to take advantage of new market possibilities. As this reliance on digital processes continues to grow, the organizations that can most efficiently acquire, organize, find, share, distribute and reuse the important multimedia content files at the heart of these processes will outperform their competitors.
In regulated industries, such as pharmaceutical manufacturing or medical device manufacturing, systems must be developed within the structure that has been put in place to protect customers, suppliers and the general public. BLUE provides two levels of competitive advantages: it not only provides superior digital asset management and digital workflow management capabilities, it also helps you meet the requirements of the regulatory structures for internal process control and verification.
We've written a paper to give you a brief overview of FDA 21 CFR Part 11 and our point of view on how BLUE meets and addresses the requirements for electronic records and signatures. Read the paper.
