Protect your material from misprints and recalls
No company is configured equal, so we offer different licensing options. All options are quick to install and easy to update.
Schlafender Hase is ISO 9001:2015 certified for Design and Software Development for Regulated Environments
TVT complies with FDA regulations (21 CFR Part 11)
TVT complies with EMA regulations (Annex 11)
TVT supports QRD and SPL submissions
Our development process includes specification of functions and their stepwise implementation. Rigorous testing with full traceability takes place at each step. Thanks to our strict quality process, users can expect any new releases to be virtually problem free.
Our experts can provide best practice guidance on how to integrate TVT into your larger workflow. We can also assist in developing SOPs that follow the best practices in your industry: this includes working closely with your supply chain to ensure the proper creation and use of your files.
TVT can be validated with our Validation Package at your site to meet requirements in regulated environments such as Pharma, Medical Device, Chemical, Cosmetic and Food industries.
The Validation Package is based on GAMP 5, using the risk-based approach over the life cycle to become GxP compliant. A complete documentation package incorporates a validation plan, requirements, risk assessment and control installation (IQ), test cases and protocols (combined OQ/PQ). A validation report is available and can be used for qualification/validation by our customers.
TVTaaS is fully validated on our servers. A validation certificate for compliance is available.
Upon request, our team is available for on-site or remote validation support.