Validation

H&A Scientific, Inc. products in our Quality Assurance Program have been validated to current pharmaceutical industry standards and the documentation is available for review by regulatory agencies or client auditors on site at H&A Scientific, Inc. (Greenville, NC). Your company will have the opportunity to audit and review all validation protocols. Our products have been designed and tested using GMP guidelines and the Quality Assurance Program at H&A Scientific, Inc. The Quality Assurance Program specifies document production, control, and issue. The Quality Assurance Program also specifies the production of Quality and Project Plans, Configuration Management, and Change Control. Controlled Functional Specifications and Design Documents have been issued. Controlled System Acceptance Test Specification documents have been executed. Conclusion documents have been issued which detail testing results. While this quality program is very thorough, it does not relieve the end-user from responsibility of on-site validation.

An end-user validation protocol package is available for our products. The package includes a User Requirement Specification and all necessary user acceptance protocols, as well as our Quality and Project Plans and Maintenance Plans for the software. The testing documents would be provided prior to installation and will require prior approval signatures from both H&A Scientific, Inc. and your company. The execution of the protocols may be carried out by your staff (who have attended training sessions). Alternatively, execution of the protocols may be contracted with H&A Scientific, Inc. H&A Scientific, Inc. can provide two persons 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, Inc. will assist in the preparation of a conclusion document. H&A Scientific, Inc. and your company will provide approval signatures for this document.

Please contact us for a quote for this service.