YOUR COMPLIANCE IS OUR COMPETENCE

Our services aim at Computer System Validation and internal Quality Management necessary in a GxP-regulated environment. We verify suitability of acquired or self-developed software and qualify the respective IT infrastructure. Furthermore we challenge your GxP-Compliance via internal audits and CAPA measures.

We validate software solutions in research, pre-clinical and clinical development, Drug Safety, registration, marketing, supply chain and production – as well as ERP-software such as SAP – and test the hardware in use for suitability. Our competencies also comprise Analysis Method Assessment, Process Validation, Facility Qualification and Purification Validation. Learn more about our service modules:

Computer System Validation

Our CSV Services
secure complete GxP-Compliance for software solutions and
IT infrastructure.

  • Valcoba CSV Assistance
  • Data Integrity
  • CSV Project Execution
  • IT-Qualification
  • Equipment Qualification
  • Re-Validierung
  • CSV Risk Analysis
  • CSV Training

Quality Management

We support you in managing CAPAs, SOPs, in Document Management as well as in establishing complete
QM-Systems.

  • GxP/CSV Fitnesscheck
  • Mock Auditing
  • Inspection Preparation
  • CAPA Management
  • QMS Implenentation
  • Person in Plant
  • Process Re-engineering
  • SOP-Management

IT-Project Management

Use our know-how in the realization of IT-Projects
(for example Evaluation Projects and Integration Projects)

  • Project Management
  • Project Support
  • PQM
  • Project Methodology
  • Project Controlling
  • Project Training
  • IT Governance
  • IT Service Management

SAP Services & Solution

We will be happy to support you in the implementation of your SAP projects, true to our motto:”Everything from a single source”

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