Quality Management System (QMS)
Experienced Partners for Development and Implementation
For pharmaceutical, biotech, and medical device manufacturers, Quality Management Systems (QMS) are the foundation for enabling the organization to operate in a compliant manner. The QMS establishes the path to compliance for the company and enables sustainable systems that meet the demands of regulators, customers, and ever-changing business environments.
We are a trusted partner in designing, building, and managing QMS programs. Our industry-leading experts understand the complex regulatory elements and the compliance systems that are required for your organization to succeed. We can help guide your team through the regulatory processes specific to your quality programs.
Our professionals ensure QMS achieves three objectives:
- Continuous improvement
- Regulatory requirements
- Establish “right-sized” processes for the phase and scope of the organization
Compliance Experts:
Whether you are proactively or reactively looking to develop and implement a QMS, our team can help.
Embracing the principles of the International Conference on Harmonization Q10 (ICH Q10) model, our experts certify your QMS can verify that required product quality is routinely met. Our team makes sure that suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.
Embracing the principles of the International Conference on Harmonization Q10 (ICH Q10) model, our experts certify your QMS can verify that required product quality is routinely met. Our team makes sure that suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.
We are aiming at an integrated solution, with a fixed time scale and related standards. Quality Management System services tailored to your needs at low costs in a time-efficient manner.
Implementation of pharmaceutical Quality Management System(QMS).
Redesign of QMS to incorporate major changes and changing business needs Quality Risk Management (QRM)., Facility, Products, QMS, Quality control, Production, warehouse, Computer system and supply chain, etc.. Writing of: SOPs, Batch records, Protocols (Validation, Qualification, Stability, etc) Conducting investigations (OOS, deviations, equipment or utility issues, etc.)
Overseeing the CAPA program Audits: execution of internal and external audits
Master Batch Record control Production Batch Records review Assist before, during, and after audits by Regulatory Agencies (FDA, MHRA, EMEA, etc) Product release Handle customer complaints Label control Generation and improvement of Quality Management System(QMS).
