CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

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

CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

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

WE HELP WITH COMPUTERIZED SYSTEMS VALIDATION (CSV), COMPUTER SOFTWARE ASSURANCE (CSA), AND THE QUALIFICATION OF MODERN IT AND CLOUD INFRASTRUCTURES.

Are your compliance and quality management processes up to date?
Tool-based validation (Jira, ADO etc.), CSA, Agile, CI/CD, XaaS-Cloud . We adapt your internal specifications within the regulatory framework so that you can benefit from current and upcoming innovations.
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What can and what must?
We support you in the implementation of regulatory requirements for the validation of computerized systems.
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Seeing through the GxP / CSV jungle?!
We offer training and workshops on general and specific topics in the CSV/GxP-regulated world.
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Do you have your suppliers under control or are you ready for an audit?
We support you in strategy, planning and execution of supplier assessments, postal audits and "on-site" audits.
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Q_COMPANY

„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.

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 TRAINING AUDIT strive to best meet the requirements of our customers.

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.

Q_EFFEKT

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”.

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.

Q_FINITY CONTACT

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MEET QFINITY^∞

ISPE India Manufacturing, Quality & Compliance Conference | 2.-3. November 2023

On 2/3 November, Frank Henrichmann, together with Global GAMP Steering Committee members Heather Watson (TenTenTen) and Thanabalan Subramanian (Integrity), will present GAMP 5 Second Edition at the ISPE India Manufacturing , Quality & Compliance Conference 2023 in Hyderabad. The programme will cover a wide range of sessions topics e.g. Annex 1, Quality & Compliance, Computerized […]

all dates

CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

WE HELP WITH COMPUTERIZED SYSTEMS VALIDATION (CSV), COMPUTER SOFTWARE ASSURANCE (CSA), AND THE QUALIFICATION OF MODERN IT AND CLOUD INFRASTRUCTURES.

Are your compliance and quality management processes up to date?

What can and what must?

Seeing through the GxP / CSV jungle?!

Do you have your suppliers under control or are you ready for an audit?

Q_COMPANY

Q_SERVICE

Q_METHOD

Q_EFFEKT

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

DATA INTEGRITY IN GXP REGULATED FIELDS

Q_NEWS

ISPE India Manufacturing, Quality & Compliance Conference | 2.-3. November 2023

QFINITY at the ISPE GAMP CoP UK Forum | September 19, 2023

QFINITY plans the ACDM Symposium for AI

May 06-10, 2023 | ISPE Europe Annual Conference

Q_FINITY CONTACT

MEET QFINITY^∞

ISPE India Manufacturing, Quality & Compliance Conference | 2.-3. November 2023

Q_NEWS

ISPE India Manufacturing, Quality & Compliance Conference | 2.-3. November 2023

QFINITY at the ISPE GAMP CoP UK Forum | September 19, 2023

QFINITY plans the ACDM Symposium for AI

QFINITY

Q_SERVICE

Q_COMPANY

CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

CONSULTING COMPANY FOR RISK-BASED QUALITY MANAGEMENT AND QUALITY ASSURANCE OF PROCESSES, DATA AND SYSTEMS

WE HELP WITH COMPUTERIZED SYSTEMS VALIDATION (CSV), COMPUTER SOFTWARE ASSURANCE (CSA), AND THE QUALIFICATION OF MODERN IT AND CLOUD INFRASTRUCTURES.

Q_COMPANY

Q_SERVICE

Q_METHOD

Q_EFFEKT

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

DATA INTEGRITY IN GXP REGULATED FIELDS

Q_NEWS

ISPE India Manufacturing, Quality & Compliance Conference | 2.-3. November 2023

QFINITY at the ISPE GAMP CoP UK Forum | September 19, 2023

QFINITY plans the ACDM Symposium for AI

May 06-10, 2023 | ISPE Europe Annual Conference

Q_FINITY CONTACT

MEET QFINITY∞

Q_NEWS

QFINITY

Q_SERVICE

Q_COMPANY

MEET QFINITY^∞