Compliant Rendering: Documentation fulfilling standards of the FDA/EMA
The Life Science industry is faced with specific and strict procedures from the FDA and the EMA. If your business has to deliver documentation to the FDA, several elements are under strict regulations and therefore needs to be controlled and in order.
It puts up a greater challenge in getting products to market faster as the tasks are complex, requires manual processes and laborious involvement. Ever-changing content must be kept in control while meeting regulatory compliance obligations quickly and comprehensively.
Some of these elements include Table of Tables, Tables of Figures, thumbnails, header, footer, watermarks and hyperlinks in the right color of blue - for example, if your business needs an application to get registered.
The solution? Automate to accelerate compliance and eliminate manual effort, by standardizing the growing volumes and variety of content to simplify critical compliance-related processes.
Strator has worked with advanced rendering products for years, and we have a deep understanding of the requirements from FDA and generally the challenges in working in the GxP world.
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.
After several years of working with the best products, Strator has become experts in delivering and managing the configuration of it to ensure the documents are compliant with the given regulations.
We are accustomed in regulated environments and can deliver Installation Qualification and other necessary or relevant documentation your quality system requires.