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+41 (0)61 712 33 33

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GxP
GxP

GxP

GOOD LABORATORY AND PRODUCTION PRACTICE WITH DIQUALIS

We ensure your compliance with the regulations that apply to your company by providing risk-based and business-oriented solutions for your quality management. From the development to the marketability, we provide you with process-oriented advice to help you achieve your regulatory and economic goals. We support you both strategically and in your day-to-day business.
Communication is the first step to success. Contact us.

Your Challenge
– Our Solutions

At every step in the value chain, the challenge is to both perform the appropriate tasks in a timely manner and to the meet regulatory requirements. This does not have be a contradiction. We integrate the applicable quality management requirements into your business processes. Our risk-based approach is the basis for effectiveness, a manageable amount of work and relaxed inspections/audits. Reduce the costs of your “Continuous Compliance”.

DIQUALIS SUPPORTS YOU
IN VARIOUS FUNCTIONS/ROLES:

Consultant

As your consultant, we answer all of your questions regarding good working practices and provide advice on the specific implementation.

 

 

 

 

 

 

 

 

 

 

Project Manager

We act as project managers in your company to control quality management processes and establish them in a target-oriented manner.

Auditor

As an auditor for GLP, GCLP and GMP, we carry out audits, for example for the qualification of service providers or for a requalification.

 

 

 

 

 

 

 

 

 

 

Trainer

Well-trained employees are the basis of an effective QMS and smooth inspections/audits.

QA Expert

We act as an external quality assurance expert to provide practical support and accompany your processes.

 

 

 

 

 

 

 

 

 

 

Our Specific
SERVICES REGARDING GxP

Chemie Konzern Qualitätsmanagement

GLP

Good Laboratory Practice

Does your laboratory want to perform non-clinical safety testing? Have you not determined yet which GLP categories should be used? Do you need external resources for the implementation? Would you like to have your existing GLP system tested for flaws or possible optimizations? Do you need support in the system maintenance and day-to-day business? Would you like to adapt your GLP system to a hybrid work model (switching between home office and office)?
Then you have come to the right place – we are your reliable partner for all aspects regarding GLP.

GMP

Good Manufacturing Practice

Do you need support in implementing, reviewing or optimizing your GMP system? Do you want to prepare your GMP system for future challenges? Are topics like CSA and cloud technology currently relevant for you? Are you looking for support in the laboratory or other areas of production?
Then you have come to the right place – we are your reliable partner for all aspects regarding GMP.
Qualitätsmanagement Produktion
Qualitätsmanagement Produktion

GMP

Good Manufacturing Practice

Sie benötigen Unterstützung zur Implementierung, Überprüfung oder Optimierung Ihres GMP-Systems? Sie möchten Ihr GMP-System auf zukünftige Herausforderungen trimmen? Sind die Themen Cloud und CSA bei Ihnen aktuell? Sie suchen Unterstützung im Labor oder anderen Bereichen der Produktion?
Bei uns sind Sie richtig – wir sind Ihr verlässlicher Partner rund um die GMP.
Unternehmensstruktur

GCP for Labs (GCLP)

Good Clinical Laboratory Practice

Do you want to assess clinical trial samples in your laboratory? Do you need support in efficiently integrating GCP requirements into your existing quality management system? Would you like to have your existing system checked for flaws or possible optimizations?
We support you in meeting the requirements for laboratories performing assessments for clinical trials according to the position paper “EMA for laboratories that perform the analysis or evaluation of clinical trial samples, 2012”.

GxP Services

DiQualis’ services in the field of GxP include:
PROJECT MANAGEMENT
At your request, we act as project managers for projects on various topics. That way, you save internal resources and benefit from an effective implementation by our experienced project managers. This also includes taking over management functions ad interim.
QUALITY MANAGEMENT TRAINING FOR EMPLOYEES
A quality management system depends on the employees. To ensure long-term success, we train your employees on the topics that are relevant to your organization. The contents are completely tailored to your needs and take a practical approach. The training also includes a simple and effective performance review.
OPTIMIZING DOCUMENT MANAGEMENT
SOP revision, document structure and the linking of documents are often the cause of unnecessarily complicated processes. We revise your documents as well as the associated roles to simplify document management and reduce the administrative maintenance.
CERTIFYING SITES
We certify your production sites on a risk basis in order to make the validation effort pragmatic. In this context, we make use of the scope that the authorities have been offering for some time and that will have to be increasingly used in the future. Of course, the optimization of the associated QA interfaces is included.
CONDUCTING AUDITS & GAP ANALYSES
We conduct audits at your company and/or your suppliers. That includes examination audits, the qualification of suppliers as well as the respective GAP analysis, among other things. This serves as preparation for inspections by authorities and for customer audits. After our audits, you will know exactly what to do.
QUALITY MANAGEMENT CONSULTING
Our consultants receive regular training to ensure that your QMS meets the current requirements of authorities and customers. Drawing on our many years of experience, we transform this theoretical basis into feasible solutions. We create a smooth interaction of business and compliance processes.

YOUR ADVANTAGES with DiQualis

We implement a quality assurance system that is tailored to your needs. Thanks to our experienced external perspective, we find potential in the system and use them in the best way possible.

EXPERIENCE WITH VARIOUS GLP AND GMP QUALITY SYSTEMS
RECOGNIZING POTENTIAL FROM A NEUTRAL EXTERNAL PERSPECTIVE
SAVING INTERNAL HUMAN RESOURCES AND COSTS
EFFICIENT, SUSTAINABLE QUALITY MANAGEMENT SYSTEM
PRAGMATIC DOCUMENTATION
ACCELERATED QM PROCESSES
USING REGULATORY REQUIREMENTS TO YOUR ADVANTAGE
INTEGRATION OF NECESSARY REGULATORY REQUIREMENTS
TURN A COST FACTOR INTO A SUCCESS FACTOR