Our Quality System

BETTER SOFTWARE – BETTER SCIENCE SINCE 1992

Our Products

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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 the FDA and Good Automated Manufacturing Practices (GAMP).

We’re proud to develop and validate our products for compliance with agency guidelines and requirements. Fundamental areas of our Quality System include:

  • 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.

 

STABILITY LABORATORY DATABASE MANAGER

Commercial off-the-shelf solution for complete management of your drug stability program.

INTUITIVE SHELF-LIFE PROJECTION SOFTWARE

Developed specifically to determine the shelf-life of drug products placed on stability.

VALIDATED & CUSTOMIZABLE REPORT GENERATION

Seamless generation of validated stability reports in a format ready for FDA submission.

DEDICATED TO CONTINUOUS IMPROVEMENT

Designed to maintain compliance with requirements of the FDA and GAMP.