Our Quality System

Our Quality System

At H&A Scientific, we believe better software equals better science. Our 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 Automated Manufacturing Practices (GAMP). 

Maintaining compliance with FDA guidelines for software development and validation of our products is one of our top priorities. Our Quality Assurance Program, supported by everyone at H&A Scientific, addresses the following areas (to name a few):

  • Production, control, and issue of SOPs and General Documents
  • Quality and Project Plans
  • Functional Specifications and Design Documents
  • Configuration Management
  • Validation Master Plans
  • CAPA and Deviation System
  • 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

By appointment, you are welcome to visit and/or audit our corporate headquarters in Greenville, North Carolina. Please call us at 252.752.4315 or email us at hainfo@hascientific.com