GxP-CC provides Quality Management Services to help you meet a wide range of regulatory laws, guidelines and quality standards, such as:
Based on a gap-analysis, which provides us insight into your current situation, we provide a tailored plan to help you achieve compliance in-line with quality standards. To accomplish this, we provide additional services such as:
In order to achieve a continual compliance within the quality management process, we provide you with training and the appropriate methodologies. The training we provide takes place at various stages throughout the project lifecycle.
In order to do this, we use a “train the trainer” concept, which allows you to conduct the training using your own resources, or where required, our resources. In addition we provide a guide for self-inspection to assist you in identifying any quality challenges, or gaps, thus continually improving the quality system.
Our services provide procedures and templates that can be tailored to suit your requirements.
Every Quality System must be able to maintain changes in a precise, reliable and effective manner. Our services provide procedures and templates that can be tailored to suit your requirements. We envision the use of two corner stones to drive change management:
Our certified auditors conduct quality audits for several purposes. These include, but are not limited to, the objective review of your quality systems, the provision of a preparation audit for an inspection by legal authorities and many other aspects of auditing.
The audit report provides a benchmark for the compliance of the quality system together with the related laws and regulations. This gives you detailed guidance so you can focus on the critical quality deficiencies.
Quality Management can be supported by a wide range of tools (e.g. Document Management System, Change Control Systems and more). Our experienced specialists and teams work with your team to help you identify the right solution for your needs.
We provide services from the evaluation phase of projects, through the specification, implementation, validation, verification and qualification phases of projects when these activities are required by you.