Support with your quality management. Regardless of whether it's audits, implementation of quality management systems or advice at inspections, knoell listens to our customer's needs in order to be able to deliver precisely tailored high-quality solutions.
Authorities in most markets require medical device companies to maintain a quality management system to obtain device approvals and registrations. We implement and maintain quality management systems (QMS) that comply with QMS regulations in medical device markets.
- QMS - implementation / maintenance (e.g. ISO 13485, 21 CFR 820, RDC 16)
- MDSAP - implementation
- CAPA - support
- QMS - interim management
- Auditing - internal / supplier (on-site / remote)
What exactly is remote auditing?
In contrast to the common audit, where the auditor visits the client and performs the audit locally, with remote audits the major contact between auditor and client is via phone and internet. This does not only apply to communication, but also to performing certain packages of the audit. Further benefits apart from avoiding personal contact in these times, are higher flexibility, lower costs and direct preparation of digital evidence. These advantages clearly outweigh the disadvantages that a lack in personal contact between auditor and auditee might be seen as.
At knoell we have substantial experience with performing complex remote audits and can guarantee a stable and secure technical infrastructure.
Quality Assurance (QA) is an essential element of animal health product development, whether in pre-clinical studies, clinical studies, pharmacovigilance or manufacturing.
Our trained QA auditors are experienced in auditing to the principles of Good Laboratory Practice (GLP), VICH Good Clinical Practice (VICH GCP) and Good Manufacturing Practice (GMP), compiling audit reports and following up recommendations.
Amongst the services we offer are:
- Facility inspections
- Manufacturing site inspections and GMP auditing, for finished products and APIs
- cGMP advice and support
- Study plan and protocol reviews
- In-phase inspections of GLP and VICH GCP studies
- Pharmacovigilance system audits
- Process audits
- Data and Study Master File audits
- GLP and VICH GCP report audits
- Training of QA and non-QA personnel
- GLP and VICH GCP implementation
- QA support; development and maintenance of tailored QA systems
- QA system audits, including corrective and preventative actions
- Independent review of QA functions and procedures
- Compilation of Standard Operating Procedures (SOPs) and policies
In the EU, the intermediates used in the manufacturing of food contact materials, the food contact materials on their own as well as the final food contact articles are required to be manufactured under Good Manufacturing Practices (GMP), in accordance with the Regulation (EC) No. 2023/2006.
Meeting such requirements differs from manufacturing site to manufacturing site, and is dependent upon the particular type of food contact material that is manufactured.
On-site audit is the best approach to be considered for these types of products. Considering our global presence, knoell experts can easily perform an on-site audit at your location and guide you through the process of achieving a GMP status for your manufacturing site.
It should be noted that such GMP requirements are not only applicable to the EU market, but in fact these are essential requirements for all food contact materials in the emerging markets.