GMQA provides quality assurance and compliance consulting to health authorities and pharmaceutical, biologics, medical device manufacturers and support service organizations, including contract manufacturers, contract laboratories, and other allied stakeholders. Our core business includes data integrity governance program consulting, quality assurance inspections, audits, training, vendor / supplier qualification, corrective and preventative action plan and compliance plan development or review, and policy and standard operating procedure development or review. If we are unable to assist with your project needs, we would be happy to recommend other trusted colleagues to assist with your project.
Data Integrity & Data Governance
In an increasingly automated and connected world, opportunities abound to create meaningful Data Science and Data Governance Programs. Our ability to protect our patients and to design innovative data processes that optimize efficiency and effectiveness, including cost-effectiveness, depends on reliable data--that is, data that is integral. GMQA would enjoy working with your Quality, Scientific, Management, and Data Science staff to assess your key CGXP data processes for data integrity risks and to enhance data process design controls. GMQA can also you develop and implement a holistic, risk-based global CGXP data governance program.
Data Integrity Training
GMQA would be happy to provide your personnel a variety of training options on the complex topic of holistic and risk-based approaches to data integrity assurance. Training includes classroom workshops to provide necessary background in regulatory expectations and industry standards followed by hands-on training. Please contact us to discuss development of a training program tailored to your personnel, your systems, and your patient safety and product quality risk profiles.
Global Supply Chain
The quality of raw materials is essential to formulation of safe and effective finished product, whether finished pharmaceutical or dietary supplement. GMQA can assist with your supplier qualification management program including data integrity audits, preparation and review of responses to Health Authority observations, and monitoring of process improvements.
GMQA shares your passion and excitement about the potential for personalized medicine to re-define the standard for patient safety based upon individual gene / gene expression profiles. Let us help you design or enhance your Pharmacogenomics Laboratory Compliance program or qualify and monitor your contract pharmacogenomics speciality laboratories.
GLP Toxicology / Bioanalytical Studies
GMQA provides Registered Quality Assurance Professional in GLPs (RQAP-GLP) background and experience to assist with your needs to conduct pre-qualification audits, in-life inspections, final report audits of your Toxicology / Bioanalytical studies. GMQA can also review the electronic source data and metadata in support of final study reports.
Quality System Audits
Robust Quality Systems are essential in any CGXP area. GMQA would be happy to help you enhance individual quality systems, such as Computerized Systems Validation, SOPs / Document and Data Management, Training, Data Life Cycle and Data Governance, Quality Risk Management, Quality Audits and Inspections, Data Reviews and Data Monitoring, and Investigations and Corrective and Preventative Actions, to help you define or enhance a holistic Quality Systems Program.
Assessment of IT Support Services & Software Suppliers
GMQA and colleagues would be happy to help you assure and document vendor quality systems through qualification audits as well as routine quality audits and monitoring of vendors that provide on-going support of your systems and electronic data, including cloud-based services.
General QA Support Services
GMQA can assist with your needs for general QA support services, including routine GxP audits, preparation and/or review of policies and SOPs, review of computer systems and validation documentation, training, and other services. Please contact us to discuss your specific needs.