CONCEPTS AND SOLUTIONS FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

We support pharmaceutical and medical technology companies in achieving and maintaining GxP compliance in the regulated domain.

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The Vision

„We are committed to a dynamic form of quality management that meets the direct requirements of the researching and manufacturing industries in the pharmaceutical and medical technology sectors.” (Oliver Herrmann, CEO QFINITY)

QFINITY has specialized in highly regulated companies since 2004 and stands for quality management that is scaled to the necessary levels and the right control objectives. Our primary focus is on identifying and assessing risks in processes. The validation of computerized systems and the assurance of data quality, integrity and availability in the regulated environment round off our service portfolio.

From the very beginning we have continuously expanded our range of services and now support companies of all sizes in the implementation of official/regulatory/company requirements.
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Logo Q-Finity

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With the high organisational and technological integration of modern companies, only a forward-looking, holistic approach can lead to success.

The maxim of QFINITY is to use our services to connect the increased complexity of the technologies, which supports and carries all essential business processes, with the enterprise structures and departments, in order to be able to control these sustainably and across system boundaries.

Our service areas CONSULTING SCHOOLING AUDIT strive to best meet the requirements of our customers.

OUR CORE TOPICS INCLUDE:

  1. Strategies for digital transformation
  2. Business process management
  3. Quality, risk, (GxP) compliance management and continuous improvement
  4. Process compliance and quality assurance for clinical trials
  5. Concepts and implementation of data governance / data quality / data integrity
  6. Concepts for handling electronic records and signatures (ERES)
  7. Process validation and qualification of equipment, plants or systems
  8. Validation and operation of ERP systems
  9. Validation of computerized systems (CSV) - clinical systems, laboratory systems, production systems, IT systems, medical technology, suppliers etc.
  10. IT infrastructure - qualification and compliance
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Q_METHOD

Doing what is absolutely necessary and omitting what is superfluous. This is where QFINITY's consulting services come in. Our profound knowledge of the regulations coupled with our many years of experience and the dedication of our employees to finding practicable solutions enables QFINITY to develop creative solutions where others see only paragraphs and regulations.

QFINITY sees itself as an "enabler", i.e. our services are designed to pick you up as a customer wherever you are organisationally located. We will work with you to identify risks and develop strategies to minimise them in a resource-efficient manner within the relevant regulatory framework.

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THE Q_EFFECT – AN ESSENTIAL FACTOR IN THE VALUE CHAIN OF YOUR COMPANY

Our work leaves lasting traces in your company - in the best sense of the word. We call this the Q_EFFECT. The Q_EFFECT works internally through a sustainable assurance of quality-relevant processes - if desired, we not only limit it to GxP relevance but also consider the "big picture".

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THE DIGITAL TRANSFORMATION IN GXP REGULATED FIELDS

You are facing the greatest entrepreneurial challenge of our time. Digitization is no longer a buzzword. The reduction of manual processes, the focus on data streams along the value-adding process chains and the increasing focus on technology in companies against the background of the constantly growing regulatory requirements have become part of everyday business life and have to be tackled. Costs and benefits must be harmonized as best as possible.

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Q_NEWS

Regulatory Compliance Check at a Contract Research Organization (CRO)

CRO contracts QFINITY to plan and conduct regulatory compliance checks.

Training und Workshop at a Contract Research Organization (CRO)

CRO contracts QFINITY to plan and conduct basic training in validation of computerized GCP systems. In a supplementary Workshop, the established QM system was analyzed to identify significant weaknesses.

QFINITY consults about the 21 CFR Part 11 in the U.S.

A major U.S. Pharma company commissioned QFINITY for the production of an expert opinion regarding the implementation of FDA 21 CFR Part 11 / EU GMP Annex 11 for the introduction of an Electronic Clinical Supply Management system, including Interactive Voice & Web Response Services (IVRS / IWRS ).

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MEET QFINITY

Our next dates


QFINITY provides Speaker for the ACDM Annual Conference 2019

11 March 2019  -  12 March 2019

The 2019 ACDM Annual Conference (ACDM19) will be held at the Radisson Blu Amsterdam Airport from the 11th to the 12th March 2019. Following the success of ACDM18 in Brussels and the feedback from delegates.

Stadt: Radisson Blu Amsterdam Airport

Straße: Boeing Avenue 2, 1119 PB Schiphol-Rijk, Niederlande


GAMP DACH Forum March 2019 - Eurotherm

12 March 2019  -  13 March 2019

GAMP DACH Forum meets at Eurotherm.

Stadt: SCHLOSSHOTEL WEILBURG

Straße: Langgasse 25, 35781 Weilburg


QFINITY provides Speaker for the German ePharma Day

05 June 2019

The German ePharma day will examine implications of the new regulations from different viewpoints for patient rights and data protection with a special focus on the national adaptations.

Stadt: Frankfurt am Main

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