The Life Science industry documents must live up to standards from FDA or EMA and therefore they must be rendered (converted) correctly. Ever-changing content must be kept in control while meeting regulatory compliance obligations quickly and comprehensively.
If, for example, your business needs to submit a registration application, each document in the application must include elements such as table summary, tables of shapes, thumbnails, header, footer, watermarks and hyperlinks in the correct blue color.
Strator is specialists in document conversion and also has a deep understanding of FDA requirements and requirements to work in a GxP world. We have configured several internationally recognized products to comply with the special FDA standards. We can advise on the acquisition of rendering and / or configure your existing product.
We are used to regulated environments and can provide installation qualification and other necessary or relevant documentation.
The rendering technology can (typically):
- Ensure compliance mandates are met with accuracy by automating content assembly processes
- Secure confidential design data across departments, formats, and repositories
- Enable rapid access to content, across devices and geographies
- Ensure recognition and identification of content through high-quality OCR for non-searchable files
In many implementations the rendering solution becomes a central rendering solution, which can provide several different systems with rendering - not only the document management systems.