Q_Service

Pars pro Toto

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 using our services to connect the enterprise structures and departments with the increased complexity of the technologies, which support and carry all substantial business processes, in order to be able to control these durably and beyond system borders.

This does not have to be done immediately, but can be done over time using logically connected and self-contained building blocks. The selection of the right building blocks is based on each building block's inherent risk (i.e. the influence on product, patient and data). We like to compare this with a puzzle: only if the pieces are connected at the right positions does the overall picture make sense later. The risk-based orientation of our methodology guarantees that projects are accompanied responsibly and cost-consciously, either holistically or in specific subject areas. By involving our customers right from the start and by efficient application of proven methods and tools, we ensure that the defined organisational, project and quality goals are achieved on time and, above all, in a manner that is inspection-proof.

CONSULTING

Our primary service is consulting. Through optimal knowledge transfer, we support clients in developing new solutions and concepts. We are also available with advice and practical help as a lively external sparring partner. If necessary, we can take on operational tasks in the short or medium term or fill positions on behalf of our clients.

From strategy formulation to the implementation of concrete measures, we offer our clients the optimal combination of consulting and coaching, with access to sustainable, proven solutions and standards. Recognizing the individual situation of the company and developing suitable concepts is one of our main strengths.

OUR SERVICE IN THE AREA OF CONSULTING

  • Starter kit for GxP beginners
  • Initial consulting on strategy development and implementation (master planning, time and resource planning, design and implementation)
  • Impact analyses, business process analyses, requirement engineering, risk management
  • Planning and implementation of validation projects (e.g. in the areas of quality management, automation, document management, clinical trial management, enterprise resource planning, laboratory, warehouse management and logistics)
  • Support for the validation / qualification of standard and configurable products as well as for individual software solutions (based on templates and standard processes for uncomplicated, efficient integration)
  • Efficient, fast and robust solutions at the interfaces between business processes, quality assurance, data integrity application and IT landscape (i.e. consulting, training and audits in all QM matters)
  • Establishment and optimization of quality management systems (business and IT, suppliers)
  • Support in the creation / revision of the internal standards and regulations
  • Project-related consulting by experienced senior consultants
  • Operational project support by junior consultants
 

TRAINING

GXP-TRAINING, IN-HOUSE SEMINARS, WEBINARS AND WORKSHOPS

Developing awareness and situational understanding - this is the objective of QFINITY training courses. This provides important stimuli for the sustained commitment of your employees and colleagues. Correlation and transparency create motivation. We prefer using the carrot rather than the stick. A satisfied team that can identify itself with the set goals is the best way to embark on new challenges.

Maintaining an up-to-date overview of the multitude of laws, regulations, guidelines, industry standards, etc. is a basic duty of employees of regulated companies. However, we understand the application of these standards in day-to-day business or in projects as the demonstration of competence in those standards. Our training and coaching services address both the basics as well as the application of these basics in day-to-day business. The proper training of employees in regulated companies (GLP, GCP, GMP, GDP, medical technology, etc.) is not an option - it is a must. If training is not successful, this represents a potential risk. The proper execution of training and qualification activities, and in addition the monitoring of their effectiveness, is an elementary component of the regulatory requirements. For external training, workshops, seminars and lectures we have worked with renowned seminar providers for many years. This includes: RQA, ISPE, Forum Institute, Concept-Heidelberg, APV, Colloquium Pharmaceuticum.

Beyond external training events, we offer specific training courses and workshops on general and specific topics in the GxP-regulated world. If desired, our training courses can be carried out with an assessment of learning success. Internal, customized training courses can be planned individually to enable cost-effective seminars when several employees are to acquire the same qualification.

OUR SERVICE IN THE AREA OF TRAINING

  • Coaching
  • Webinars & Seminars
  • In-house training
  • Project-related consulting by experienced senior consultants
  • Operational project support by junior consultants
 

AUDIT

Check your compliance and process compliance with external experts from QFINITY. In today's highly diversified organizational reality, it is imperative that all parties involved in a business process follow the defined criteria. Regular audits provide confidence and help to identify weak links at an early stage.

GXP-AUDITS OF SUPPLIERS AND CONTRACTORS

„An audit is a systematic, independent and documented process to obtain audit evidence and to evaluate it objectively in order to determine the extent to which audit criteria are met.“ In qualification and validation processes, GxP-regulated companies can rely on supplier activities and documents. This is based on a relationship of trust between supplier and customer, which is based on in-depth knowledge of the supplier's working methods and quality. This can be determined prospectively through an appropriate supplier assessment process. We support you in developing an audit strategy, as well as the planning and implementation of supplier qualification assessments, postal audits and on-site audits.

OUR SERVICE IN THE AREA OF AUDITS

  • Mock Audits (FDA, EMA)
  • Internal quality audits (QM processes and systems)
  • Supplier evaluation (e.g. software, hosting partner, contract research organizations - CROs, outsourcing partners)
  • On-site audits of potential partners (on-site audits)
  • Repeat audits of partners who have already been audited (follow-up audits)
  • Preparation of specification documents for the planning, execution and documentation of supplier audits
  • Creation of benchmarking criteria for supplier selection