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, fillings may be inaccurate or delayed. GXPQS has the capability and expertise to ensure data integrity, to ensure documentation is 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, 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 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 Drive Ste.115-32 

The Woodlands, Texas 77382