VALIDATION

VALIDATION ROUTINE WITH STANDARD TEST PROTOCOL

D4InfoNet can be validated against all international standards and guidelines. For example, this is relevant to manufacturers of medical equipment and medicinal products.

Certification & Validation

THE VALIDATION PACKAGE

The D4 validation package support includes, for example;

  • Support our customers’ validation activities, whether they need to comply with the EU GMP or FDA regulations.
  • Implementation of procedures and risk-based test cases to provide sufficient documentation for IQ and OQ.
  • Our approach covers the regulations for pharmaceutical products (FDA and EU-GxP) and medical equipment.
  • Support for regulated customers also covers correct documentation and evaluation of any change the customer requires after validation.
  • A complete support package is provided for customer validation activities consisting of a qualification plan, IQ and OQ test protocols and a qualification report.
  • We provide a manageable, user-friendly and time-saving solution.
  • We help our customers make their validation process more manageable and flexible.
  • Our customers can save time and focus more on their business.

Customer cases:

Read about how some of our customers use D4InfoNet to support the validation activities:

One system that can handle both document management and validation

Hekedantal

Simple and inexpensive validation with the standard test protocol

Vitrex
Customer reviews
Iso Certified

D4 is certified DS/EN ISO 90001:2015 og DS/ISO/IEC 27001:2013

These two standards represent quality and information security – two of our highest priorities. This applies equally to our management system, applications, development and services.