ServoTech
Engineering and consultancy firm providing regulatory compliance, qualification and validation, machine and workplace safety, and documentation services for regulated industries (pharmaceuticals, medical devices, automated manufacturing). Offers project execution, supplier coordination and implementation support for automated systems with a focus on GMP/cGMP, data integrity and CE/MDR requirements.
Industries
Nr. of Employees
small (1-50)
ServoTech
Products
AQV®
Agile Qualifizierung und Validierung nach cGMP for pharmaceutical and medical device manufacturing, combining agile techniques and methods with traditional validation frameworks.
Qualifizierungs- und Validierungsdokumentation
Erstellung vollständiger, regulatorisch sicherer Dokumentationen für Qualifizierung und Validierung im GMP-regulierten Umfeld von DQ, IQ, OQ, PQ bis Prozess-, Reinigungs- und Methodenvalidierung sowie CSV.
Schulungen & Workshops zu Validierung & Compliance
Praxisnahe Schulungen und Workshops zu GMP-Validierung, Risikomanagement, CE und Dokumentation rollenspezifisch und anwendungsnah.
Dokumentation & Schulung
GxP-konforme Dokumentation und praxisnahe Schulungen für Teams in regulierten Branchen.
Maschinenqualifizierung (DQ/IQ/OQ/PQ)
Qualifizierung von Anlagen und Maschinen von Designqualifizierung bis Leistungsqualifizierung.
Prozessvalidierung
Validierung kritischer Herstellprozesse nach EU GMP Leitfaden Anhang 15 und 21 CFR Part 210/211, sowie ISO 13485 für Medizinprodukte.
AQV®
Agile Qualifizierung und Validierung nach cGMP for pharmaceutical and medical device manufacturing, combining agile techniques and methods with traditional validation frameworks.
Qualifizierungs- und Validierungsdokumentation
Erstellung vollständiger, regulatorisch sicherer Dokumentationen für Qualifizierung und Validierung im GMP-regulierten Umfeld von DQ, IQ, OQ, PQ bis Prozess-, Reinigungs- und Methodenvalidierung sowie CSV.
Schulungen & Workshops zu Validierung & Compliance
Praxisnahe Schulungen und Workshops zu GMP-Validierung, Risikomanagement, CE und Dokumentation rollenspezifisch und anwendungsnah.
Dokumentation & Schulung
GxP-konforme Dokumentation und praxisnahe Schulungen für Teams in regulierten Branchen.
Maschinenqualifizierung (DQ/IQ/OQ/PQ)
Qualifizierung von Anlagen und Maschinen von Designqualifizierung bis Leistungsqualifizierung.
Prozessvalidierung
Validierung kritischer Herstellprozesse nach EU GMP Leitfaden Anhang 15 und 21 CFR Part 210/211, sowie ISO 13485 für Medizinprodukte.
Services
Iterative validation approach for automated manufacturing systems that integrates supplier cooperation, regulatory requirements and continuous delivery of validation artefacts.
Development and execution of validation strategies, documentation, and qualification testing (IQ/OQ/PQ) for facilities, equipment and computerised systems.
Assessment of machine residual risks, CE conformity support, hazard analyses, and implementation/documentation of workplace safety measures including LOTO and key safety elements.
Preparation and optimisation of technical documentation (operating manuals, risk assessments, SISTEMA calculations) and implementation support for content management systems.
Supplier assessment, review of supplier documentation, and execution of supplier-related acceptance tests and FAT/SAT coordination.
Advisory services for engineering and quality teams during new builds, system modifications, revalidations and commissioning of production and packaging systems.
Iterative validation approach for automated manufacturing systems that integrates supplier cooperation, regulatory requirements and continuous delivery of validation artefacts.
Development and execution of validation strategies, documentation, and qualification testing (IQ/OQ/PQ) for facilities, equipment and computerised systems.
Assessment of machine residual risks, CE conformity support, hazard analyses, and implementation/documentation of workplace safety measures including LOTO and key safety elements.
Preparation and optimisation of technical documentation (operating manuals, risk assessments, SISTEMA calculations) and implementation support for content management systems.
Supplier assessment, review of supplier documentation, and execution of supplier-related acceptance tests and FAT/SAT coordination.
Advisory services for engineering and quality teams during new builds, system modifications, revalidations and commissioning of production and packaging systems.
Expertise Areas
- Qualification and validation strategy for regulated industries
- GxP quality management and compliance
- Agile validation methods for automated systems
- Machine safety and CE conformity
Key Technologies
- Computerized System Validation (CSV)
- Automation and Process Profiles (APPs)
- Factory and Site Acceptance Testing (FAT/SAT)
- Installation/Operational Qualification (IQ/OQ)