Validation & Training

All H&A Scientific, Inc. products in our Quality Assurance Program have been validated to current pharmaceutical industry standards. All documentation is available for review by regulatory agencies or client auditors on site at H&A Scientific’s Greenville, NC headquarters. Your company will have the opportunity to audit and review all validation protocols.

All H&A products have been designed and tested using GAMP guidelines and our own internal Quality Assurance Program, which specifies document production, control, and issue. It also details the production of Quality and Project Plans, Configuration Management, and Change Control.

The Quality Assurance Program also issues controlled Functional Specifications and Design Documents, executes Controlled System Acceptance Test Specification documents, and details testing results with Conclusion documents. However, while this quality program is very thorough, it does not relieve the end-user from responsibility of on-site validation.

As another option for our valued partners, end-user validation protocol packages are available for our products. The packages include User Requirement Specifications and all necessary user acceptance protocols, as well as our Quality and Project Plans and Maintenance Plans for the software. The testing documents will be provided prior to installation Execution of protocols may be carried out by members of your company’s staff who have attended one of H&A’s expert training sessions. Alternatively, execution of the protocols may be contracted with H&A Scientific, which will provide experienced personnel to execute the testing protocols. Your company will need to provide Quality Assurance assistance in the form of witnessing raw data and test result sheets. Upon completion, H&A Scientific will assist in the preparation of a conclusion document, and H&A and your company will provide approval signatures for this document.

Please contact us at 252.752.4315 or hainfo@hascientific.com for a quote for this service.