21 CFR Part 11 compliant
Multiple file types
Keep track of all your submission relevant documents
The Cunesoft Regulatory Document Management Solution (RDMS) helps you keep track of all of your submission-related documents. With simplified tagging and full text search, you’ll be able to easily and effectively manage your documents.
Single storage repository
Facilitates collaboration across disciplines
Utilizes industry best practices
21 CFR Part 11 compliant approvals
Integrated, non-obtrusive processes support you in creating your documents and content rather than creating another obstacle. Requests reviews from your peers, manage review versions and perform 21 CFR Part 11 compliant approvals including electronic and digital signatures right from within the system.
- Supports multiple document formats
- Facilitates conversion to formats required by regulators
Conversion of documents to the right format for submission
With speed, efficiciency and compliance in mind, the cune-RDMS platform includes automatic and seamless creation of PDFs from your source documents – making them ready for use in your electronic submissions.
cune-RDMS and V.E.R.A.
Virtual Electronic Regulatory Assistant
…guides first time users through each step of the software
…assists during compilation
… helps to find the right document via tagging
… guides on compliance fulfillment throughout the entire regulatory workflow
…can do even more
Learn by doing
“This leads to a new dimension of user experience and work efficiency.”
Rainer Schwarz CEO Cunesoft