PreVal

PreVal

PreVal

CLOUD BASED PRE-VALIDATION & VERIFICATION SYSTEM

QAM | Quality Assurance Management
Quality Assurance Management, Inc.
COUNT ON QAM
SAFETY
QUALITY
EXPERIENCE
RESOURCES
FOR YOUR NEXT CONSTRUCTION PROJECT
OF EXPERIENCE IN THE HIGH PURITY INDUSTRY
25 YEARS
OVER
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ADVANCING THIRD PARTY INSPECTIONS & TESTING

QAM is changing the way third party inspection and testing services are provided in the life science and semiconductor industries by means of it’s Electronic Documentation Systems (EDS), experienced personnel, investment in technology, process improvements, and industry proven inspection / testing equipment.

Pre-Validation Value Add

Validated / impact system TOP punch lists have been virtually eliminated and overall time and cost to complete the validation process per system have been significantly reduced due to QAM’s processes, experienced inspectors, fully searchable TOP, Electronic Documentation System, and PreVal - QAM's Electronic Pre-Validation System.

Third Party Representation

QAM provides independent representation, inspections, certification testing, surveillance reporting, production statistics, installation verification, and TOP documentation which ensures systems meet the engineering design and Installation Qualification / Commissioning requirements.

SAFETY

Our safety programs, procedures, and training courses focus on daily inspection or testing tasks. QAM employees have the knowledge required to perform their work in a safe, accurate, and productive manner with a focus on reducing human errors.

PreVal

PreVal is a cloud based electronic pre-validation TOP documentation verification system. ISO drawing material and weld data are verified accepted by PreVal’s proprietary and automated processes. Fully searchable electronic TOP documentation can be turned over during the project, reducing the overall cost and duration of your IQ protocol.

ELECTRONIC DOCUMENTATION SYSTEM

This system produces PDF inspection and verification reports which allow full text searching with embedded validated documents such as MTRs and COCs. Custom form workflows allow inspectors to track TOP status throughout the project. The real time TOP is stored and backup through AWS and Google services.

QUALITY SYSTEM

The quality system establishes our standards and policies for company documentation, equipment calibration and maintenance, training, corrective and preventive actions, auditing, and services provided.

Life Sciences,
Pharmaceutical & Biologics

QAM provides materials of construction inspections and documentation verification to the engineering design, datasheets, ASME BPE, ASTM Specifications, and USP requirements. Welding inspections, XRF-PMI, installation verification, hangers / supports, and slope verification are performed to verify conformance to the engineering design, approved drawings, and ASME BPE.

Bioprocessing Equipment
Pre-Delivery Inspection

QAM provides equipment specific inspections and VDR review on vessels, skids, heat exchangers, filter housings, valve bodies, and other equipment and components to the engineering design, datasheets, and ASME BPE. In-process, partial FAT, and final inspections are performed at the vendor’s facility to identify quality issues prior to shipping.

EXPERIENCE

We have completed successful projects both large and small for owner / end users, engineering design firms, general contractors, equipment fabricators, and process piping contractors in the United States for over 25 years.

Semiconductor,
Microelectronics, Solar

QAM provides inboard and outboard helium mass spectrometer leak testing on gas equipment and systems, HI-VAC, and abatement exhaust systems. Particle count testing is performed at a specified velocities, flow rates, or Reynolds Number. Impurity gas analysis is performed on-line / real time for moisture and oxygen. H2, CO, CO2, CH4, and light hydrocarbons can be analyzed by sample cylinder.

ISO 8573
Compressed Air Testing

QAM performs ISO 8573 PWO and microbial sample collection at your facility. The test media is collected by QAM and sent to Trace Analytics, LLC. for analysis and reporting. Our third party independence, high purity experience, and ISO 8573 experience make QAM the right choice for baseline, commissioning, or validation testing. QAM is an authorized distributor for Trace Analytics, LLC.

RESOURCES

Hiring QAM means the project will be supported by the QAM Management and Start Up Team, Safety Manager, QA Manager, and Equipment Manager. We have an extensive inventory of calibrated  inspection and testing equipment. Project execution is driven by our Project Quality and Safety Plans.

Mechanical
and Process Piping

QAM provides inspection and documentation verification on other validated / impact process systems constructed of P1, P8, P43, P45, PVC/CPVC, copper, and various lined pipe systems. Our focus is on verifying to the extent necessary that the materials of construction, fabrication, required examination, required testing and TOP has been performed by the fabricator in accordance with the engineering design.

Fabricator Audits

QAM performs vendor / fabrication audits to evaluate the company’s qualifications, capabilities, fabrication methods and processes, documentation, quality system, organization, and facility workflow.

COMPANIES WORKED WITH

FLUOR
Genentech
SKANSKA
Alcon
TURNER
Astra Zeneca
JACOBS
SANOFI PASTEUR
NOVARTIS
DPR
SANOFI GENZYME
Pfizer
Agilent Technologies
Biogen
Agilent Technologies
Takeda
LEND LEASE
MERCK
AMGEN
AMGEN
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TO CONTACT US ABOUT OUR TRUSTED 3RD PARTY SERVICES