About Qualitätswandel Dana Graupner

Qualitätswandel Dana Graupner GmbH is a consultancy organization that helps companies, including those in the pharma and life sciences sectors make process transformations that require re-engineered quality management systems.

Qualitätswandel is German for ‘Quality Transformation’, which encapsulates the company’s mission to optimize quality management at organizational and systems levels.

The company leverages its deep-rooted GMP and ISO expertise to help clients navigate the highly complex quality assurance landscape and achieve their goals. Its wide-ranging services include developing a GMP quality management system (GMP), ISO 9001 and ISO 13485, process analysis, training and audits.

Continuous improvement

The company’s ethos is based on the ‘Kaizen’ concept of continuous improvement and is committed to offering customized services highly tailored to the individual needs of  pharmaceutical and medical product manufacturers, as well as to clinical and pharmacy organisations. Its services portfolio includes:

• Project management: specializing in quality assurance and laboratory practice.
• Regulatory compliance: including admissions support and regulatory affairs management.
• Quality Management Systems: in accordance with ISO 9001, ISO 13485, 21 CFR Part 820, EU GMP and ICH Q10 guidelines.
• Document support: Writing of technical documents to meet ISO and GMP standards, including translation and digitization of manufacturing documents.
• Query Processing: including complaints, deviations, changes and CAPAs.
• Cleanrooms and Equipment: Planning, qualification and maintenance in accordance with EU-GMP guidelines Annex 1 and ISO 14644.
• Risk assessment: according to ISO 14971 and ICH Q9.
• Method and Process Validation according to CLSI Guidelines, ICH Q2, EU-GMP Guidelines Annex 15, USP <1225>, 21 CFR Part 211.
• Computer Systems Validation in accordance with GAMP 5 guidelines.
• Raw Material and Supply Management: according to ISO 9001, ISO 13485, ISO 15378, EU GMP Guidelines Part 1 chap. 7 and Annex 8.
• Stability study organization to comply with ISO 13485, ICH Q1 and 21 CFR Part 820 standards.
• Audit services: Planning and execution as co- and lead auditor.
• Inspection services: Support during inspections by authorities and notified bodies.
• Training: Creation of bespoke staff training courses for delivery on site or online.

Track record

Qualitätswandel was established 2019 by Dana Graupner, a highly experienced pharmaceutical quality expert, who is now the company’s Managing Director. The company is based at Bresewitz on Northern Germany’s Mecklenburg-Vorpommern Baltic Coast, with team members located all over Germany.

The company has conducted scores of successful engagements and currently lists more than 40 companies as clients.

Dana Graupner’s passion for enabling career progression for parents has made Qualitätswandel a beacon of empowerment, with an employee-friendly, remote working culture that also forms a competitive edge in ensuring greater agility and responsiveness.

In January 2024, the company finalized the transition from standalone enterprise to full limited liability company status, as Qualitätswandel Dana Graupner GmbH.

In 2023, Qualitätswandel was named as one of Europe’s Top Ten Pharmaceutical QA service providers by Pharma Tech Outlook magazine and the following year was named by Consulting magazine as one of its three highest ranked winners of its 2024 Top Consultant Awards.

Resources

Click on Qualitätswandel: Your External Partner for Quality Management Systems to lean more (German language).
Click on Advice through Leadership to watch video.