Computerized Systems Validation

Your digital systems create, store or transfer data which are subject to the current GxP regulations? You want to use electronic signatures?

To form a sound basis, conduct a risk-based analysis and evaluation of your processes right when planning and designing new systems. In this way, synergies can be used and the validation can be carried out transparently and efficiently.

We consult and support you with all topics and questions relating to the validation of computerized systems.

Compliance with 21 CFR Part 11 and EU GMP Annex 11 over the entire life cycle

  1. Development/Improvement of CSV-Concepts
  2. Strategy for cloud-based solutions
  3. Embedding in the entire SOP landscape
  4. Initial GxP-Assessment

  1. Execution of supplier audits
  2. Validation activities and documentation
  3. User Access Management
  4. Audit Trail Review

  1. User Training
  2. Sustainability of validated state
  3. Data Migration
  4. Retirement of computerized systems