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    Qualitätswandel Dana Graupner GmbH

    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.

    The company uses its in-depth knowledge of QMS and regulatory requirements in GMP and ISO standards to support companies in redeveloping their quality management processes to achieve regulatory compliance and optimize their products and processes. Its wide range of services includes GMP quality management system development, achieving ISO 9001 and ISO 13485 standards, process analysis, training and audits.

    Vision & Mission

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

    The company’s ethos is based on the ‘Kaizen’ concept of continuous improvement, as summarised in the words of renowned US TV producer Philip Rosenthal: “Whoever stops getting better, has stopped being good.”

    Its commitment to offering customized services highly tailored to individual cases has made Qualitätswandel a first-choice service provider for life sciences organizations, both those seeking to build QA systems from scratch or those seeking to upgrade QMS to strengthen their regulatory compliance postures.

    Products & Services

    Qualitätswandel offers a  range of consultancy services tailored to the needs of the pharmaceutical and medical product industries, as well as to clinical and pharmacy organisations.

    Service offerings include:

    • Project management: including interim and personnel management in the areas of quality assurance and laboratory practice.
    • Regulatory compliance: Advising and supporting stakeholders in complying with regulatory requirements for pharmaceutical and medical devices, including admissions support and regulatory affairs management.
    • Quality Management Systems: Establishment and maintenance of QMS 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, along with digitization, review and release of manufacturing documents.
    • Query Processing: including complaints, deviations, changes and CAPAs.
    • Cleanroom design: Planning, qualification and maintenance of cleanrooms in accordance with EU-GMP guidelines Annex 1 and ISO 14644.
    • Risk assessment: according to ISO 14971 and ICH Q9.
    • Equipment Qualification and Maintenance
    • 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 of audits of suppliers and service providers as co- and lead auditor.
    • Inspection services: Support during inspections by authorities and notified bodies (regional councils, TÜV, MDSAP, etc.) as well as development and implementation of corrective measures.
    • Training: Creation of bespoke staff training courses for delivery on site or online.

    Company History and Structure

    Qualitätswandel was established 2019 by Dana Graupner, a highly experienced pharmaceutical quality expert, who is now the company’s Managing Director. Its first engagement was with a pharmaceutical startup struggling to build a robust quality assurance system, which revealed a general market need for a consultancy focused on improved quality management. This has been proven correct with more than 40 companies now listed as clients.

    Dana Graupner is also passionate about enabling career progression for mothers and  Qualitätswandel has become a beacon of empowerment for working parents, with an employee-friendly, remote working culture.

    Over the course of more than 45 projects, the company has now grown to a team of eight consultants and subject matter experts, including Project Management specialists Ulrike Borchard, Verena Ruhland, Stefania Kincler, Elisabeth Lieschke and Roman Ickert, all with in depth pharma industry experience. The company is based at Bresewitz on Northern Germany’s Mecklenburg-Vorpommern Baltic Coast, with team members located all over Germany.

    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 Top Consulting Agency as one of its three highest ranked winners of its 2024 Top Consultant Awards.

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    Qualitätswandel Dana Graupner GmbH

    Contact Information
    Address: Am Anger 9, 18356 Bresewitz, Germany
    Telephone No: 0049 173 2008291
    Email Address: [email protected]

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