IText also proved to be easy to pick up, with Dmitrii making use of the wealth of user documentation. “We began using it and it looked like it would be very suitable for us, it was extremely easy to connect to and work with.” “After that, we decided to research a new library and I found iText” continues Dmitrii. When the problems proved to be insurmountable, it was clear a better solution was needed. “It's difficult to make a design with this format.” “We had some problems working with styles inside XSL-FO” says lead developer Dmitrii Saltykov.
#SPEEDY FOR JIRA PDF#
However, they quickly ran into technical problems.įirstly, with one of the key product requirements of embedding files within a PDF as attachments, but also with the design element. Initially they began development of Speedy PDF using a competing commercial PDF library SDK and utilizing Apache’s XSL-FO to design their document templates. This means that the electronically signed Speedy PDF records can also facilitate passing regulatory audits.Īctually, iText was not RadBee’s first choice when developing their solution. It provides a virtual, time-stamped paper trail that shows all proper governance was followed during workflows, with evidence that all of the required documentation was provided, reviewed, and signed.Ĭrucially for RadBee’s customer requirements, the sign off process complies with regulations such as FDA CFR 21 Part 11. Speedy PDF Sign-Offs benefits organizations by delivering an easy, trustworthy way to demonstrate that a team or enterprise followed their standard operating procedures, such as industry-specific testing processes when releasing a product.
#SPEEDY FOR JIRA INSTALL#
It takes just seconds to install and is immediately available to support your entire Jira instance, projects, and issue types by creating a beautifully formatted Speedy PDF record of a specific moment in time, which can be electronically signed and archived safely in a matter of seconds. This is an Atlassian Cloud Application designed to help agile teams capture electronic signatures and document issue resolution and approvals without slowing down their flow. One such product is Speedy PDF Sign-Offs for Jira Cloud. I wanted to see less waste and more impact.” “Shortly after that” she says, “I launched RadBee to deliver to life sciences companies quality management processes that align with their product development needs.
#SPEEDY FOR JIRA SOFTWARE#
RadBee was established to fill a need for custom eQMS software which RadBee’s co-founder, Rina Nir experienced at first-hand with the pain of processing a mountain of regulatory-related documents and bills for her successful MedTech startup. A popular choice in these (and many other) sectors are the solutions developed by Atlassian, such as Jira and Confluence. In turn, companies and organizations working in these sectors have increasingly adopted electronic quality management (eQMS) software solutions to assist with their workflows and processes. Similar regulations and guidelines are in effect from European authorities and others, and achieving the standards needed for compliance and auditing is crucial in MedTech, biotech, and pharmaceutical fields. In a nutshell, CFR Part 11 defines a set of conditions designed to ensures the authenticity of any submitted electronic file, which means if an electronic file is compliant with the requirements of 21 CFR Part 11, it can be inspected by the FDA. Historically, FDA submissions and audits required hard copies signed with a pen, however, as paper documents became electronic files and items (i.e., databases), the FDA needed to define acceptable digital documentation parameters. Serving companies from startup to enterprise, they develop innovative quality management processes that align with their customers’ product development needs.Ĭompanies in these sectors lean heavily on such quality management processes, since they often need to comply with stringent regulatory requirements, such as the United States Food and Drug Administration’s (FDA) 21 CFR Part 11. RadBee is a UK-based technology company which specializes in providing custom eQMS software solutions to the MedTech, biotech, and pharmaceutical sectors.
0 kommentar(er)
