By Pharma Consulting
Pharma benefits of Körber Validation Services
Körber offers a range of computer validation, pharmaceutical process validation and a wide range of other types of validation in pharma and biotech to help life sciences companies meet the challenges of regulation.
Process validation in pharmaceutical industry and biotech contexts is mainly about ensuring data is collected and evaluated over the product lifecycle from design stage through to commercial production to establish scientific evidence that the process is capable of consistently delivering a high-quality product. Process validation in pharma involves a series of activities taking place over the lifecycle: Process Design, Process Qualification, and ongoing Process Verification.
Körber’s pharma computer system validation (CSV) experts can support life sciences companies in using validation to minimize business risks, stabilize manufacturing processes, and ensure product safety, while complying with regulatory standards at national and international levels.
Körber’s pharmaceutical validation services are important for regulated companies in the pharma, biotech, and medtech sectors for numerous reasons that include minimizing business risks, creating more stable manufacturing processes, and ensuring product safety.
Körber validation consultants are immersed in the pharmaceutical, biotechnology, and medical devices industries and adopt both traditional and agile processes. Its flexible validation services are user-oriented, efficient, and scalable to meet the requirements of any size company.
Pharma Validation Support Portfolio
The Pharma Consulting portfolio of validation services addresses the full range of needs for validation in pharmaceutical industry and biotech, including:
- Risk management with a risk-based validation approach
- Analysis of the Quality Management System (QMS) regarding process validation
- Creation of validation strategy and implementation plans to support projects
- Pharma 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 Biotech Validation
Körber life sciences specialists define validation processes to suit individual clients, taking into account the latest directives to identify possible compliance risks:
- GMP validation and other guidelines affecting quality control and data integrity such as ISO 9001, GMP validation to EU 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
- Pharma 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
Medical Device Validation
Consulting experts from the business unit Pharma at Körber 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 software validation services include:
- Evaluation and optimization of quality management system (QMS) and technical validation 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.
Machine and MES Qualification
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 in pharma 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 validation documentation.
Körber can also support clients in all phases of Werum PAS-X implementation and take over tasks such as qualification and validation, greatly easing the burden on organisation and personnel during the introduction of a Manufacturing Execution System (MES).
Körber is an international technology group with around 10,000 employees and more than 100 locations worldwide.
Körber turns entrepreneurial thinking into customer success to shape technological change, offering inspirational products, solutions and services in five Business Areas: Digital, Pharma, Supply Chain, Tissue, and Technologies.
The Körber Business Area Pharma offers a unique portfolio of integrated solutions to deliver key differences across the total pharma value chain.
As a leading pharma consulting expert that works in personal partnership with its customers, Körber possesses deep understanding of specific process and regulatory challenges of pharmaceutical, biotech validation, and medical devices manufacturers and how to optimize manufacturing processes by developing tailor-made solutions for customers’ individual needs and time requirements.
Consulting experts from the business unit Pharma at Körber offer a broad portfolio of services that include machine qualification, manufacturing execution systems, or validation in pharma.
To ensure customers remain competitive, Körber’s industry-leading experts connect them to the future by consulting on innovations like digital maturity, augmented reality solutions, small batches, and targeted treatment.