Validation
Validation is an essential component of quality assurance and ensures that processes, systems, and equipment operate stably, reproducibly, and in compliance with regulations. The goal is to demonstrate that a process or system reliably and consistently delivers the desired results – in accordance with regulatory requirements (e.g., GMP, FDA, ISO).
PROVEN SAFE PROCESSES – REPRODUCIBLE & COMPLIANT
Systematic Validation – demonstrably effective, permanently compliant
Reaching the Goal Effectively – with Experienced Specialists
We support you with a clear, risk-based approach throughout the entire validation process – compliant with standards, traceable, and tailored to your processes.
Our Services at a Glance
Validation Strategy Development
Creation of customized validation concepts to ensure regulatory compliance
Computer Software Validation
Validation of computerized systems according to current guidelines (e.g., GAMP 5)
Design of Experiment (DoE)
Use of statistical experimental design to optimize processes and validation studies in development
Cleaning Validation
Verification and documentation of cleaning procedures to prevent cross-contamination
Process Validation
Ensuring robust and reproducible production processes through targeted validation
CPP
Support in the definition and implementation of critical process parameters (CPP) to ensure stable processes.
Your Benefits with DPhE
Quality Assurance
GMP-compliant implementation guaranteed
Traceability
Structured, auditable documentation
Professional Competence
Technical and regulatory expertise
Process Orientation
Efficient processes through risk orientation