Frequently asked questions about engamp®

Get a comprehensive overview of basic aspects of the engamp product line. We also provide you with key information on licensing our modules and explain how you can contact our support team.

  • General questions
  • Questions about licensing
  • Support & Updates

General questions:

Discover the basics of engamp®, its functions and compatibility with other systems.

engamp® is a quality management software specially developed for regulated industries such as the pharmaceutical industry, medical technology, cosmetics and the food supplement industry. It supports companies in efficiently managing document-based processes, fulfilling regulatory requirements (e.g. ISO 13485, FDA 21 CFR Part 11, EU GMP) and driving digital transformation in quality management.

Yes, engamp® can be integrated with third-party systems such as ERP, MES and DMS solutions via interfaces (APIs). This enables a seamless data flow and reduces manual effort.

Yes, engamp® is a comprehensive solution that can be accessed via any modern web browser. engamp® is a completely web-based solution that can be accessed via the common web browsers (Firefox, Safari, Chrome ...). Engamp can also be used via mobile devices without restriction.

Yes, engamp® can also be deployed in the “on-premise” form. The installation is carried out on your company's servers.

engamp® is compliant with relevant regulations and standards such as:

  • ISO 9001 (quality management)
  • ISO 13485 (medical devices)
  • EU GMP guidelines
  • FDA 21 CFR Part 11 (electronic records and electronic signatures)
  • GAMP 5 (computer system validation)
  • ISO 15189
  • ISO 17025
  • Swissmedic
  • Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients
  • IFS

Our sales team is available to you via several channels:

E-mail: sales@digital-ls.de
Phone: +49 2542 20201-0

Questions about licensing:

Find out more about the licence models, customisation options and access rights.

engamp® is available as Software-as-a-Service (SaaS) or as an on-premise solution.

engamp® is based on the named user licence model. Users can be divided into the following categories: power users (QM employees, administrators), medium users (department heads/executives) and light users (the majority of the workforce). For an overview of the detailed functional scope of the user categories, please contact us at:

E-mail: sales@digital-ls.de
Phone: +49 2542 20201-0

engamp® is offered in a flexible subscription model, regardless of whether it is used in the cloud or on-premises. In order to give you a price indication, we need some information. Please fill out the price inquiry form or contact us at:

E-mail: sales@digital-ls.de
Phone: +49 2542 20201-0

Our licences are tied to individual employees. If there are changes in personnel, a licence can easily be transferred to another person.

Support & Updates:

Find out about the support available, the update frequency and the maintenance process.

Support requests can be made via the following channels:

  • Regular security updates: Monthly
  • Functional enhancements: Quarterly
  • Major releases: As required, based on customer feedback and regulatory requirements

When your maintenance contract expires:

  • You do not receive new updates or patches
  • You only have limited support access
  • There is an increased risk of security vulnerabilities

We recommend renewing the maintenance contract in good time.

Yes, but older versions do not receive any security updates or regulatory adjustments. For full functionality and compliance, it is advisable to update to the latest version.

Yes, if you are already a customer of ours, you can also use our new product line. Please get in touch with your project contact to discuss the specific steps.