By Pharma Consulting
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Körber is an international technology group with around 10,000 employees and more than 100 locations worldwide.
We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire.
At the Körber Business Area Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions.
With our consulting services we support pharma manufacturers to optimize processes and digitize manufacturing. Utilizing profound knowledge of regulatory requirements, track & trace processes management, recipe optimization, validation strategy and execution, as well as augmented reality solutions in manufacturing, we unlock the potential of our client’s productivity.
Product and service offerings
Körber’s consultancy services cover a range of highly specialized skills and knowledge sets. These include:
- Validation Consulting: for pharma, biotech and medical device products and applications, with computerized system validation (CSV) expertise to support clients in complying with national and international regulatory standards while also reducing risk, stabilizing manufacturing processes and ensuring product safety. Of course, we support you in validation of cloud based solutions.
- Machinery Qualification: we qualify your equipment in accordance with regulatory requirements. This includes but is not limited to Körber machines; but also for third party equipment. This is done under consideration of time and budget constraints.
- MES consulting: independent consulting and implementation support for complex Manufacturing Execution Systems, including Master Batch Records (MBRs) and Electronic Batch Recording (EBR), along with vertical planning and horizontal machine data integration. Talk to us about MES as a Service or MES in Dark Factories.
- Track & Trace consulting: Full project support from requirement analysis for serialization, aggregation, etc., through system and vendor selection to final implementation. Tailored solution for Asia Pacific based clients available.
- Line Optimization and Guided Workflows: assisting clients to transition their organizations and processes to full Pharma 4.0 digital integration based on Internet of Things (IoT) and other concepts, using innovative Augmented Reality training and visualization based on LION technology.
- MOM consulting: Manufacturing Operations Management expertise in optimizing Business Process Management, including data & analyses, ensuring data integrity and software implementation.
- Digital Maturity Assessment: Assess your organizations’ current digital maturity with guidance by our industry experts and learn how you benchmark compared to the market. We help you to identify projects with real ROI.
- Supply Chain Management Consulting: Holistic analysis of material flows across regulated industries in various project phases, improved by components such as efficient Warehouse Management System (WMS that can adapt rapidly and cost-effectively to new regulatory requirements and processes.
Company history and structure
Founded in 2001 as Systec & Services GmbH (its legal entity), Pharma Consulting has found new recognition as part of the overall Körber group brand, forming part of the Körber business area Pharma that offers products and services for life sciences clients. These include unique offerings of integrated solutions that span consultancy, inspection, handling, packaging machines and materials, track and trace, and industry-leading software, all designed to unlock the full potential of pharmaceutical, biotech and healthcare businesses.
The Consulting journey began as a spin-off from Propack Data in 2001, evolving by 2005 into offering manufacturing IT systems integration solutions for life sciences. During 2012, the company expanded its expertise into serialization. In 2017 Systec & Services was acquired by and integrated to the Körber group.
In 2019, the company expanded its offerings to include Pharma Warehouse Management solutions before becoming an integral part of the overall Körber brand during 2020.
The company’s leadership includes Jörg Erdmann as Managing Director and Dr. Martin Printz as Vice President for Sales & Marketing.
Quality, Regulatory and Standards
Körber is a leading source of expertise and solutions in highly regulated industries with intimate knowledge of the regulatory requirements that govern data security and integration as well as medical devices and GxP operations, such as ISO 9001, EU GMP Annex 11, FDA 21 CFR Part 210/211, and Part 11 — Electronic Records / Electronic Signatures (ERES), as well as In Medical Device Regulation (MDR) and Regulation (EU) 2017/745 on medical devices, ISO 13485, FDA 21 CFR Part 820 and Part 11.
The company’s quality management is licensed to DIN EN ISO 9001:2015 standards. It offers business management and validation services that follow GAMP® 5 guidelines on best practices, such as risk-based, scalable V-model or alternative procedures. Its services also comply with current regulations for client industries, e.g. EU GMP Annex 11; FDA 21 CFR Part 210/211, and Part 11; or ISO 13485.