Your users will love this lean SOP management

The Cunesoft SOP system is a ready to use system for all your SOP needs, covering content creation, collaboration, 21 CFR Part 11 compliant processes and training needs in one platform.

Image is not available

Easy creation

Paperless working

Build in Training

One click audit preparation

Paperless working – speed up

Distribute electronic copies of your SOP draft to your peers and accept or deny their suggestions with one click. Then send the SOP for electronic approval. The built in configurable approval workflow ensures that all approvers sign electronically according to FDA 21 CFR Part 11 requirements. Once approvals are completed, the system automatically creates a secure PDF version within your effective SOP library.

  • One-click production of training records in case of an audit
  • Straight forward review and approval process
  • System alerts when periodic reviews are needed
  • Easy creation of new SOPs

  • Seamless migration of existing SOPs into the system

  • Integrated training and record keeping

Train your employees on SOPs

Once SOPs have been made effective use the built in training manager function to manage employee training on SOPs. Employee training records are captured within the training records matrix.

  • Training quizzes to measure employee understanding
  • Eliminates risk of using obsolete documents
  • Paperless publication eliminates waste

One click audit preparation

Manage SOP trainings for all employees with just a single click. Define training quizzes and measure training efficiency automatically within the system. Prepare audits within minutes instead of hours by creating audit relevant reports comfortably within the software.

cune-SOP and 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 software

…assists in audit preparation

… helps to remind when periodic reviews are needed

… 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

Contact us and enjoy a FREE Demo

Request a Demo                                   Contact us