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.

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Intuitive Shelf-Life Projection Software

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

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Validated & Customizable Report Generation

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

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Dedicated to Continuous Improvement

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

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