Quality Management Services
GxP-CC provides Quality Management Services to help you meet a wide range of regulatory laws, guidelines and quality standards, such as:
- ISO 13485; ISO 20000; ISO 14971; ISO 27001
- GxP Implementations of ISO / 21 CFRs / EU Guidelines
- Change Management / Deviation Management
- CAPA Controls and Monitoring
- Audit Preparation (FDA, LRQA, European Regulatory Authorities and ISO)
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:
- Project Management for Implementation. Our project leaders work closely together with your personnel to implement long-term and reliable quality standards.
- Documentation. To assure a fast and compliant start up, we provide the necessary templates for SOPs and other documents required to ensure compliance. These templates are adapted to suit your needs. In all instances, specific documents related to your business are prepared and provided to you during the course of a project.
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:
- Risk management drives the processes to identify and mange risks. The templates and procedures we provide cover a wide range of risks and allow flexible procedures to mitigate these risks.
- Corrective and preventive actions (CAPA) help improve your products and reduce risks. Based on our experience, we provide a consistent set of templates and procedures, which allows a lean CAPA methodology and includes Change Control and Deviation Management.
Audits (FDA & ISO)
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.
To learn more how we can get and keep your business compliant, Contact Us About Our Quality Management Services