QA and QMS Development

The Quality System is the infrastructure that defines a company’s ability to provide consistent, compliant, and high-quality deliverables. All operations are governed by the Quality System and oversight of the system and processes by QA is integral to whether a company is successful. If development operations are not appropriately documented, it’s as though they didn’t happen. If data and documentation are not controlled, filings may be inaccurate or delayed. GXPQS has the capability and expertise to ensure data integrity and documentation are secure and controlled.

Services:

  • Author, review, evaluate and implement documentation and documentation systems (GXP procedures, policies, quality manuals, protocols, reports, and related forms, and specifications). 

  • Phase-appropriate, product-specific QS development. 

  • Develop, evaluate, and conduct training programs and/or systems for personnel operating in GLP, GCP, GDocP, GMP, GDistP, and GVP environments. 

  • GXP audits – review/audit internal systems and perform initial, ongoing, and for-cause audits of vendors and service providers to ensure compliance, appropriateness, and adequacy of systems and processes. 

  • Review and approval of GXP documents for compliance to relevant regulations, guidelines and Industry practice, including written procedures for consistency, accuracy, appropriateness, and readability. 

  • Track and monitor deviations from critical processes to ensure that compliance issues are resolved and corrected. 

  • Work with the product development team to establish quality standards and monitor manufacturing parameters for process improvement. 

  • Ensure that employees working in regulated areas are appropriately trained and aware of and promote quality requirements that are essential to a culture of quality. 

  • Provide regular written feedback/reports to Management regarding the status of the QS, including outsourced products and services including continuous improvement metrics. 

  • Continuous process improvement planning and implementation. 

  • Review and evaluation of product return and recall information to identify specific problems or trends over time. 

  • FDA (regulatory) Quality Metrics development and reporting.

  • Compliance program development and oversight.

Contact Us

(713)-882-1987

info@gxpqsllc.com

8000 Research Forest Dr  Ste.115-32 

The Woodlands, Texas 77382