Quality Management Systems are required for all FDA regulated entities, whether GMP, GLP or GCP. Some parts of the QMS are fairly straightforward, easy to develop and implement, whilst some require deep expertise. Even startups require some degree of Quality Assurance and Quality Management Systems and it takes an expert to tailor a QMS system for a startup. Globiox has a vast amount of experience in developing and “right-sizing” QMS to meet the needs of start-ups, GMP manufacturers, GxP Contract Research Organizations, GLP Pre-clinical laboratories, GCP CROs, GCP clinical sites, IT departments, virtual GxP companies, GxP software and mobile device developers, and suppliers to the FDA-regulated industries. Globiox also performs audits to ensure that the QMS is followed and is effective. Globiox has expertise responding to and performing remediations for FDA 483s and Warning Letters that have resulted from inadequate QMS.
Some of the processes we have helped implement include:
- Complaints, with regulatory reporting, investigation, CAPA, and effectiveness checks
- Deviations, with investigations, CAPAs, and effectiveness checks
- Nonconformances with OOS, investigations, CAPAs, and effectiveness checks
- Document control and other change control processes
- Internal audits
- Supplier management including purchasing control, supplier evaluation, and ongoing monitoring
- Training programs
- Equipment and facility calibration, maintenance, and cleaning programs
- Design control for medical devices
- Warehousing and shipping procedures
- Procedures for releasing product
- Many other procedures related to Quality Assurance, Quality Control, and other functions