Our Commitment to Quality

Every release of TVT is subject to multiple rounds of regression testing, automated batch testing with hundreds of client files and an exceptionally large group of Beta customers.

Due to our strict quality process, TVT does not have issues with our new (".0") releases like many other software companies do. TVT is the Market leader but is far from the “Bleeding Edge”.

 

 
 

Certification and Compliance

  • SH is ISO 9001:2008 certified for the "Design and Development of Software for Regulated Environments".
  • TVT fully complies with the FDA regulations (21 CFR Part 11).
  • TVT fully complies with the EMA regulations (Annex 11).
  • TVT can assist with 21 CFR 820 compliance

Our Software Development Process

TVT is GxP and GAMP 5 compliant, our developers use and work with the Scrum framework and Microsoft Team Foundation Server. 

 
 

Validation Process:

Validation Support:

TVT Validation Process
TVT Validation Support

TVT and TVTaaS are fully validated to meet the requirements in regulated environments such as Pharmaceutical, Medical Device, Chemical, Cosmetics and Food industries.

The different standards (e.g. GMP, GAMP5, etc.) are integrated into our qualification and validation processes. A complete documentation package incorporating IQ, OQ, PQ Test Cases & Protocols is made available and can be used for the qualification/validation by our customers. 

Upon request, TVT experts are available for on-site or remote validation support.

Validation Certificates are also available for our TVTaaS platform. 

 

 
 

Best Practice Guidance and SOP Creation

Our software training classes are based on industry best practices that we have learned working with many clients over many years.

Our Experts can provide Best Practice Guidance in the day-to-day usage of TVT integrated within your larger workflow. We can assist in developing SOPs that follow the best practices in your industry and can work with and educate your supply chain on the usage and creation of your files.