Datenintegrität Data Integrity Validation Validierung Qualification Qualifizierung Beratung Schulung Audit Consulting Training

CONSULTING COMPANY 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.

 

Q_COMPANY

 

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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Datenqualität Data Quality GxP Manufacturing Clinical Trials EU-GMP Arzneimittel Medicinal Products Medizinprodukte

Q_SERVICE

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.

... read more Validierung von ERP Systemen SAP HANA Infor ALCOA Validation of ERP Systems

Q_EFFECT

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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DATA INTEGRITY IN GXP REGULATED FIELDS

Data is an essential part of our lives and many things cannot be expressed without it. Whereas data used to be bound primarily in fixed form on paper or other media, in the information age data can be evaluated and combined at will. Manipulations cannot always be detected early enough. The answer to the challenge of ensuring the evidential value of electronic data is data integrity.

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Q_NEWS

Change to S4 / HANA for a globally established SAP R/3 system of a pharmaceutical company

S4/HANA is the new version of SAP that brings fundamental changes in data management and requires extensive technical customization and testing as part of a technical update. QFINITY ensures the quality of the upgrade in the role of Validation Manager, which also includes the development of a plan for running parallel versions and, in particular, for updating the validation documents. The SAP smartShift Tool is used, which allows a semi-automatic modification of the source code and whose qualification is part of the project.

Roll-out SAP and EWM (Extended Warehouse Management) worldwide

The SAP and EWM systems constituting the core company systems for the financial and especially the logistical processes are to be consolidated at a global pharmaceutical company.  Existing legacy systems are to be replaced and their data migrated. QFINITY provides the project quality assurance for change management, document life cycle, testing and data migration.

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MEET QFINITY

Our next dates


Meet QFINITY at the 35th GAMP DACH Forum in Frankfurt am Main

03 September 2019  -  04 September 2019

This event will feature three expert presentations on topics proposed by the 34th GAMP D-A-CH Forum participants. In addition, reports on CSV inspections and the work of the active Special Interest Groups and working groups will be presented. Participation is free of charge (except for travel and dining expenses), but requires a separate registration as an active member of GAMP-D-A-CH. Mr. Oliver Herrmann - QFINITY CEO - will present the results of the last GAMP EU Steering Committee meeting.

THE SQUAIRE at airport

60549 Frankfurt (Main- line station area)


QFINITY leads "Introductory seminar validation of computerized systems for beginners"

23 September 2019

Compact introductory seminar for CSV beginners, presenting the basics of the validation of IT systems. Contents: Fundamentals - Legal framework - SOP standards in GxP environments - Basic definitions and key principles – Guidance and interpretive aids - Approaches and methods - The risk-based approach - V-model and alternative process models - Classification of systems and how to assign classes - Life cycle model - Integration of suppliers - Validation of computerized systems in a nutshell - Organization, roles, responsibilities - Requirements and project management – From commissioning to retirement and decommissioning.

Hilton Hotel Mainz

Rheinstr. 68, 55116 Mainz

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