By Pharma Consulting
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Körber: Validation Services
Körber offers a range of systems and process validation services that help pharmaceutical, biotech, and medical device companies meet the challenges of national and international regulation.
Körber’s computerized system validation (CSV) experts can support life sciences companies in using validation to minimize business risks, stabilize manufacturing processes, and ensure product safety.
The Pharma Consulting portfolio of validation services addresses the full range of regulatory challenges for pharma, biotech, and medtech companies, including:
- Risk management with a risk-based validation approach
- Analysis of the Quality Management System (QMS) regarding validation processes
- Creation of validation strategy and implementation plans to support projects
- Computer System Validation (CSV), including equipment and system qualification
- GAMP® 5 based solutions, using V-model or alternative procedures to suit customer-specific applications
- Creation of Standard Operating Procedures (SOPs) and training management
- Data integrity assessment and assistance
- Complete audit management and support
- Support for validation of the cloud solutions Infrastructure as a Service (laaS), Platform as a Service (PaaS), and Software as a Service (SaaS)
- On-site support and implementation.
Pharmaceutical and biotechnology validation
Körber life sciences specialists define validation processes to suit individual clients, taking into account the latest directives to identify possible compliance risks:
- Validation services that consider ISO 9001, EU GMP Annex 11, FDA 21 CFR Part 210/211, and Part 11 — Electronic Records / Electronic Signatures (ERES)
- Business Process Management and audit management, e.g. in preparation for an FDA audit
- Computer system validation of Manufacturing Execution Systems (MES), including support for all phases of Werum PAS-X implementation to ease burden on personnel during MES introduction of MES.
Validation for the medical devices industry
Consulting experts from the Körber business area Pharma can support medical device manufacturers in conforming to medtech regulatory standards at national and international levels with expertise and solutions that are always practical and up-to-date.
Medical device validation services include:
- Evaluation and optimization of quality management system (QMS) and technical documentation according to Medical Device Regulation (MDR) and Regulation (EU) 2017/745 on medical devices
- Compliance Management Services in consideration of ISO 13485, 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.
Integration of new machinery, extensive retrofit of existing equipment and maintenance of validated status throughout entire lifecycle all require a high degree of coordination to reduce downtime and secure rapid regulatory approval.
Körber equipment and validation specialists use proven and tested processes for commissioning and validation to expedite machine qualification and accelerate progress into full production.
Körber’s LOCK methodology can handle all aspects including project management, liaison with the equipment supplier, commissioning, qualification testing and regulatory documentation.
Specific benefits of the LOCK machine qualification approach include:
- Leverage: Cross-discipline involvement of all experts from first stage allows technical and regulatory expertise to be leveraged throughout the project for faster and better results
- Knowledge: Körber machine qualification experts are fully trained on the full range of solutions providing then with enhanced insights to guide the customer from initial design to go-live
- Organization: Using only trained Körber equipment experts allows the service to minimize time and optimize effort for customer benefit
- Coordination: Working closely together, the disciplinary teams track actions daily, utilizing efficient channels while remaining independent and fully committed to customer needs
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