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The Vision
QFINITY∞, a management consultancy for risk-based quality management, quality assurance, GxP compliance and continuous improvement of processes, and computerized systems with a focus on data quality and integrity.
We offer professional compliance consulting for pharmaceutical and medical technology companies. We support start-ups, SMEs and global corporations along the entire product life cycle.
We are committed to an integrated quality managment approach that, scaled in its scope and detail to the necessary degree, optimally integrates the human factor into the process landscape and is oriented towards the right control objectives.
Our focus is on identifying and evaluating process risks and collaborating with you to define and implement appropriate measures.
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.
OUR SERVICES INCLUDE:
- Strategies for digital transformation
- Business process management
- Quality, risk, (GxP) compliance management and continuous improvement
- Process compliance and quality assurance for clinical trials
- Concepts and implementation of data governance / data quality / data integrity
- Concepts for handling electronic records and signatures (ERES)
- Process validation and qualification of equipment, plants or systems
- Validation and operation of ERP systems
- Validation of computer-aided systems (CSV) – clinical systems, laboratory systems, production systems, IT systems, medical technology, suppliers etc.
- IT infrastructure – qualification and compliance
ON SITE IN GERMANY
Our network of experts is represented at many locations in Germany and dedicated consultants are selected according to your specific needs. Our expertise in consulting, training and audit offers you a secure roadmap through the paragraphs of regulatory requirements.
On the basis of our proven methodological toolkit, we are ready for deployment as quickly as possible. We work with you to develop a tailor-made concept for the optimal implementation of your business cases.
THINKING OUTSIDE THE BOX
Our many years of experience from many customer relationships have taught us to think integratively and across processes. It goes without saying that we not only address the GxP risks, but also consider them in conjunction with the relevant business risks. In this way, a risk matrix is created that enables you as an entrepreneur to take a holistic view of risk management and to approach decision-making processes in a sustainable manner.
Our target audiences are primarily companies that are governed by European, American and Asian laws and regulations*. We cover the entire GxP range from GLP, GCP and GMP to GDP as well as medical devices (GMP) and have excellent knowledge of the resulting requirements for the validation of computer-aided systems and the electronic records stored in them.
*e.g. 21 CFR Part 820, 11, 211, MPG, MDSAP, MDR, IVD-Guidline, ISO 13485, EU-GMP, AMG, AMWHV, ICH E/Q, ICH-GCP, ISO 14155, EU Clinical Trials Regulation
