Green Mtn Quality Assurance
Helping You Build A Healthier World...
Green Mtn Quality Assurance, LLC
1497 Golf Course Rd
Warren, VT 05674
United States
ph: 802-496-5810
fax: 802-496-4217
info
Services
GMQA provides quality assurance and compliance consulting to pharmaceutical, biologics, medical device manufacturers and support service organizations, including contract manufacturers, contract laboratories, and other contract service providers. Our core business is 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.
Example Interests:
Electronic Data Integrity
In an increasingly electronic world, the integrity of electronic data is critical to assuring patient safety and product quality. Does your Quality Unit know how to routinely audit electronic data including a review of electronic audit trails? GMQA can assist training your Quality, Scientific, and Management staff to conduct effective and efficient electronic data reviews. 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 audit needs.
Pharmacogenomics
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 raw data in support of final study reports.
Quality System Audits
Robust Quality Systems are essential in any GxP area. GMQA would be happy to help you enhance individual quality systems, such as Change Control, CAPA, SOPs / Document Management, Training, Validation, etc, or help you define or enhance a holistic Quality Systems Program.Qualification of IT Support Services & Software Suppliers
GAMP 5, released by ISPE in February 2008 (www.ispe.org), proposes risk-based leveraging computerized system supplier quality systems and testing in support of your system implementation. GMQA can help you assure and document vendor quality systems through pre-qualification audits as well as routine quality audits to monitor vendors that provide on-going support of your systems.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.
Please contact us to discuss your specific needs.
Green Mtn Quality Assurance, LLC
1497 Golf Course Rd
Warren, VT 05674
United States
ph: 802-496-5810
fax: 802-496-4217
info
