Validation Services
We support you with a broad-based validation team. Our experts are at home in the pharmaceutical, biotechnology, and medical devices industry and are masters of both traditional and agile processes. The flexible validation services are user-oriented, efficient, and scalable to meet the requirements of any size company.
TruMinds offers a wide range of validation services for your processes, application and equipment. We guarantee that your producs meet quality demands and comply with regulations.
Pharmaceutical industry
- Validation services that consider EU GMP Annex 11, FDA 21 CFR Part 210/211, and Part 11 — Electronic Records / Electronic Signatures (ERES)
- Computer system validation of Manufacturing Execution Systems (MES)
- Business Process Management and audit management, e.g. in preparation for an FDA audit
Medical devices industry
- Evaluation and optimization of the quality management system and technical documentation according to Medical Device Regulation (MDR) and Regulation (EU) 2017/745 on medical devices
- Compliance Management Services in consideration of FDA 21 CFR Part 820 and Part 11
- Electronic Records / Electronic Signatures (ERES)
- Audit management and support, e.g. as preparation for an MDSAP - Medical Device Single Audit Program