Quality Management System: GMP, GDP
Planned, digitally implemented, and successfully inspected.
Diapharm supports clients with planning and documentation, preparing for audits and inspections, and adapting to changing regulatory or organizational requirements. Our services include:
- GMP consulting and gap analyses for pharmaceutical companies
- Establishing a QMS for pharmaceutical companies in accordance with EU GMP and GDP guidelines
- Designing and implementing an eQMS in accordance with EU GMP and GDP guidelines
- Supporting the transition from an existing QMS to an eQMS
- Maintaining and continuously improving quality management systems
- Performing self-inspections
- Preparing for, supporting and following up on regulatory inspections
- Assuming regulatory functions and responsibilities
Tailored, GMP-compliant Quality Management
Diapharm develops quality management systems tailored to each company’s regulatory requirements, workflows and organizational structures. When setting up a new system, we create the technical and organizational framework for its digital implementation as an eQMS from the outset.
Standard Operating Procedures reflect actual processes, establish clear responsibilities and make daily operations easier. The result is a quality management system that is robust from a regulatory perspective, efficient and audit-ready. In addition to QMS and GMP/GDP consulting, Diapharm can also assume regulatory functions within your quality management system as needed, for example by acting as Qualified Person.
Digitally Advancing Existing QMS
Diapharm analyses existing structures, processes and interfaces and identifies the regulatory, organizational and process-related adjustments required for the transition to an eQMS. Based on this assessment, we further develop the necessary QMS structures and support their digital implementation.
The technical implementation can be carried out with a service provider already selected by the client or with a suitable technology partner. One of the technology providers Diapharm works with is Digital Life Sciences, with its GxP-compliant eQMS platform engamp®.
Are you looking to implement an eQMS or take your existing QMS to the next digital level?
