QA-Services

ESTABLISH SUSTAINABLE QUALITY WITH DIQUALIS

The independence of quality assurance is a general requirement of various quality management systems. Our experienced employees manage your quality assurance system or support your internal quality assurance unit with their expertise. From the system maintenance to supplier audits, we cover the entire range of operations.

Communication is the first step to success. Contact us.

YOUR CHALLENGE
– OUR SOLUTIONS

The lack of experience or resources to establish an independent quality assurance unit is a hindrance for a smooth daily business. With an external quality assurance unit/quality management representative, you save internal resources and avoid conflicts of interest in your staff’s areas of responsibility. We manage your quality management system and support you in preparing for inspections by the authorities.

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 Employee

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

OUR EXPERTISE
iN QA Services

EXTERNAL QUALITY ASSURANCE

Do you need support in establishing independent quality assurance? Does your quality assurance staff need the advice of a neutral expert? Do you have temporary peaks in the workload? Is the implementation of an independent quality assurance in a small team impossible without internal conflicts of interest? Do you want to avoid using internal resources for quality assurance? Do you need an external perspective on internal inspections or external audits?

Then you have come to the right place – we are your reliable partner for all aspects regarding quality assurance.

QA SERVICES

DiQualis‘ quality assurance services include:

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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.

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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.

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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.

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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.

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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.

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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 discover potential in the system and use it in the best way possible.

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EXPERIENCE WITH VARIOUS GLP AND GMP QUALITY SYSTEMS

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RECOGNIZING POTENTIAL FROM A NEUTRAL EXTERNAL PERSPECTIVE

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SAVING INTERNAL HUMAN RESOURCES AND COSTS

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EFFICIENT, SUSTAINABLE QUALITY MANAGEMENT SYSTEM

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PRAGMATIC DOCUMENTATION

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ACCELERATED QM PROCESSES

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USING REGULATORY REQUIREMENTS TO YOUR ADVANTAGE

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INTEGRATION OF NECESSARY REGULATORY REQUIREMENTS

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TURN A COST FACTOR INTO A SUCCESS FACTOR