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Web-based Regulatory Document Management Solution Built Just For You

cune-RDMS

Easy to use and fully compliant. Cunesoft’s Regulatory Document Management Software – cune-RDMS – helps you keep track of all of your submission-related documents.

Unique System Benefits

At Cunesoft, Your Investment In Our Solution Equals Our Investment In Your Success!

Keep track

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.

Built-in PDF Rendering

With speed, efficiency and compliance in mind, regulatory management solution – cune-RDMS – includes automatic and seamless creation of PDFs from your source documents.

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
RDMS-Meta-Data-Management

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.

Single storage repository

Facilitates collaboration across disciplines

Utilizes industry best practices

Authoring templates as optional add-on available

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
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Document management software

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
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 Download Important Information For Free

Purchasing Professional Software Should Be A Fact Based Decision.

Like Nothing You’ve Seen Before

A Picture Is Worth A Thousand Words… Watch Our Video

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Meet Your Build-in Assistant V.E.R.A.

Virtual Electronic Regulatory Assistant

Vera …guides first time users through each step of the software. …assists in getting 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 
guides first time users through each step of the document management software.
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.

Contact us
CEO Cunesoft

Rainer Schwarz – CEO

Daniel Koppers – CTO

COO

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
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 What We Have Achieved With cune-RDMS

Track Record

over

500

users

over

6000

managed products

less than

3 weeks

 implementation time

less than

3 months

until return on investment

Request a Free Software Demo

Experiance the Power of cune-RDMS in a Call with our RDMS-Experts

VERA…