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Our Quality System

We are proud of our Quality System at H&A Scientific, Inc. We all work together to maintain compliance with FDA guidelines for software development and validation of our products. By appointment, you are welcome to visit and/or audit our corporate headquarters in Greenville, North Carolina.

The H&A Scientific, Inc. Quality Statement is:
H&A Scientific, Inc. is continually maintaining and improving its established Quality Assurance Program which is designed to maintain compliance with requirements of FDA's Good Manufacturing Practices (GMPs).

The Quality Assurance Program, supported by everyone at H&A Scientific, Inc., addresses the following areas (to name a few):
  • Production, control, and issue of SOPs and General Documents
  • Quality and Project Plans
  • Complete Functional Specifications and Design Documents
  • Configuration Management
  • Documented Software Testing
  • Change Control
  • Maintenance Plans
  • Monitoring adherence to SOPs through internal auditing procedures
  • NIST traceable calibration of instrumentation and equipment
  • Compliance with current regulatory requirements
H&A Scientific, Inc. is continually maintaining and improving its established Quality Assurance Program which (more...)
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H&A Scientific, Inc. has been creating programs for the laboratory since 1992. (more...)