How do I make sure my FDA submissions are compliant?
By Roger Beharry Lall | July 4, 2014
The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) requires that submitted documentation meets their electronic common technical document (eCTD) format. In addition, the software used to create the regulatory submissions need to follow 21 CFR 11. While these requirements may seem stringent, the goal is to ensure that Life Sciences organizations have control over their data, including who enters it and who modifies it. The FDA also wants to make sure that the data can be easily and accurately accessed by the appropriate people. Overall, there needs to be controlled processes for generating this data.
Helping Life Sciences organizations with submissions preparation
Having been in the document conversion industry for over a decade, we know a thing or two when it comes to creating compliant documents. And, as being compliant is a major part of creating a submission for the FDA, it’s important for your organization to rely on software that will assist you in creating compliant content.
Creating compliant submissions with Adlib PDF Enterprise
PDFs generated using Adlib PDF Enterprise meet both the technical requirements for PDF submission and are compliant with the FDA and EU requirements for use of electronic systems. Above and beyond the basic requirements for compliant submissions, in terms of an enterprise-grade rendering solution, Adlib offers:
- Centrally managed document-to-PDF conversion
- Accurate Optical Character Recognition (OCR) engine
- Performance-oriented scalability and load balancing
- Integration with EMC Documentum and other ECM systems, as well as business tools like Dassault ENOVIA PLM and K2 Blackpearl
- An intelligent Rules Engine for metadata-driven process automation
- Application of digital signatures and PDF security
- A reliable and highly available architecture
- A simple web-based management console
Ensure your FDA submissions are compliant
In order to ensure your FDA submissions are complaint with regulations and are created using software which meets Document Access and Usability requirements and meets the PDF Specification requirements, only use software which is designed to guarantee your documents are up to par. Learn more in this third-party report which outlines Adlib's Advanced Rendering solution and its approach to compliance within its software development lifecycle.
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