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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

The validation of processes and systems is a regulatory requirement and provides documented evidence that previously specified requirements and acceptance criteria are reproducibly met – during ongoing use, in a traceable and audit-proof manner.

Reaching the Goal Effectively – with Experienced Specialists

DPhE understands the requirements of the life science industry and offers comprehensive services from a single source: Our specialists cover all qualification disciplines as well as process and cleaning validations.
Upon request, we create user requirement specifications, obtain quotes, and conduct supplier negotiations. We accompany you from delivery and installation to final acceptance – with our own measurement personnel and equipment for qualification, validation, maintenance, and calibration.
Technical Report No. 3 (Dr. Stefan Schenderlein)

Practical Challenges

Unclear or changing regulatory requirements
High documentation effort and lack of internal resources
Uncertainty in defining critical parameters and acceptance criteria – Critical Process Parameters (CPPs)
Risk of deviations during audits and inspections
Lack of structure in the validation process

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