- February 23, 2021
- Deboshree Sarkar, Product Marketing Manager
The motivation of speed to market drives the Lifesciences industry we all know. In recent years and due to the COVID 19 pandemic, they face massive pressure as they face more competition, regulations, and control of their prices. So they must automate their processes to reduce the cost, boost their efficiency, minimizing the risk of manual handling, and speed up their business process while still being compliant with regulations.
Transforming the document workflows to be more modern and automated by getting rid of the outdated paper-based processes has already begun within the Life Sciences industry. They have realized the importance of digital document solutions that bridge the gap between their existing paper and the digital documentation process.
As a document productivity solution company, what we have learned from our experience with our Life Sciences customers is that bringing life-saving medicines and therapies to market is a significant challenge, and these companies needed to find a long-term partner who is ready to work with them to understand their process while helping them build the document ecosystems that sets them for success.
The US FDA regulation 21 CFR Part 11 and SAFE-BioPharma for the pharmaceutical industry mandates electronic documentation for submission to the FDA and e-signatures for approval, informed consent, and agreements. These agreement documents could be the Electronic Common Technical Document(eCTD) or the New Drug Application(NDA).
Time is money in a real sense for this industry, and for that reason optimizing the total quality management while saving time with paperwork and resources is a crucial goal. Here is where a Pharmaceutical grade software solution like Foxit’s PDF solution plays a vital role. It is not just a robust and mature desktop solution but also FDA regulation compliant and SAFE-BioPharma certified.
Foxit’s PDF Editor is built with keeping in mind the Healthcare and Pharmaceutical Industry requirements. The unique set of features helps speed up the process involved in compiling reports while reducing error margin. Powered with powerful and best in class features for generating the table of contents, bookmarks, hypertext links, e-signatures, and other essential pdf document editing features, has helped ensure any document for transfer of regulatory information facilitates creation, review, and archival of the electronic submission. And all this while being compliant with the requirements set out by the regulatory authorities.
One of the most important features provided by Foxit’s PDF solution is e-signatures with seamless DocuSign integration. The wide range of business processes within the life sciences sector that has benefited from e-signatures are Clinical Trials, Manufacturing, Contracts (sales), Legal, Procurement, and Human Resources. Foxit’s Life Sciences customers have seen faster approvals of applications with a reduced margin of errors, thereby making the process of bringing life-saving medicines and therapies to market faster and easier.
To learn more about Foxit’s PDF solution for Healthcare click here and to download a free trial click here.
Can you please share references on how Foxit products are compliant with FDA 21 CFR Part 11 requirements?
Hope this helps: https://www.foxit.com/esign-pdf/maintain-industry-compliance/