Unique System Benefits
At Cunesoft, Your Investment In Our Solution Equals Our Investment In Your Success!
The Cunesoft Regulatory Document Management Solution helps you keep track of all of your submission-related documents.
21 CFR Part 11 compliant
Integrated and built on best practices, cune-RDMS streamlines your regulatory document management processes.
Keep Track Of All Your Submission Relevant Documents
With simplified tagging and full text search, you’ll be able to easily and effectively manage your regulatory documents.
- Integrated document tagging
- Always up-to-date and compliant
- Easy to use
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.
21 CFR Part 11 compliant approvals
Integrated, smooth processes support you in creating and editing your regulatory documents and content rather than creating another obstacle. Requests reviews from your peers, manage review versions and leverage 21 CFR Part 11 compliant approvals including electronic and digital signatures right from within the system.
- Built-in PDF Rendering
- Facilitates conversion to formats required by regulators
Authoring Templates Option
Cunesoft partnered with the leading supplier for authoring templates to make the most out of your documents.
- Ensure compliance with health authority specifications for PDF file
- Authoring efficiency & consistency – eliminates retraining with MS Word upgrades
- Implement company standards and conventions
- Comply with CTD document granularity requirements
- Enable document and submission navigation ease for reviewers
Like Nothing You’ve Seen Before
A Picture Is Worth A Thousand Words… Watch Our Video
Meet Your Build-in Assistant V.E.R.A.
Virtual Electronic Regulatory Assistant
… assists in getting regulatory documents stored in the correct folders.
… helps to prepare an eCTD submission.
… guides on compliance fulfillment throughout the entire regulatory workflow.
… can do even more.
Meet Our Managment Team
Deep Knowledge Of The Life Science Industrie And Excellent Regulatory Understanding Makes Them Deliver Regulatory Peace Of Mind
Cunesoft offers a ready to use and pre-validated regulatory compliance suite. Our cloud based software has been built to fulfil regulatory needs holistically and end to end. Our vision is to keep it as simple as possible while delivering compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
Rainer Schwarz – CEO
Daniel Koppers – CTO
Jim Nichols – COO
Become A Member Of The Cunesoft Family
Over 500 Active Users Love Our Compliance Software Tools.
We selected cune-eCTD because of the compliance guarantee... it gives us great peace of mind.GermipheneRegulatory Affairs Manager
The fast support of Cunesoft is understanding in this industry. Moreover, we like the intuitive user interface very much.MakrocareHead of Regulatory
We never thought that FDA compliance can be so easy and at the same time cost effective with an all in one annual fee.AthenexRegulatory Specialist
What We Have Achieved With cune-RDMS
until return on investment
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Experiance the Power of cune-RDMS in a Call with our RDMS-Experts