VALIDATION & TRAINING

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Validation & Training

 

Our services are all based on our commitment to our customers and our intense desire to exceed the most demanding criteria. We offer in-house and end-user validation and product training.

Validation

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.

Training

Keeping with its mission of rapid deployment H&A Scientific provides user training on-site and via the Web for all of our products. After the successful completion of training, attendees will be given a training certificate suitable for framing. H&A understands the possible need for new user training and therefore offers additional user training upon request. Each training course is designed to be hands-on with interactive discussion groups, and typically only takes two days.

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

Interested in Pharmaceutical Stability Training Courses in your region? Please contact us and we will explain the options we provide, both within the USA and Internationally. E-mail us at hainfo@hascientific.com.

 

 

 

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What Our Clients Say About SLIM

  • H&A Scientific offers top-notch customer service. They are always prompt to respond, they follow-up to make sure everything is still working satisfactorily, and their customer service representatives are friendly, helpful, professional, and extremely knowledgeable.

  • H&A has been very helpful over the years whenever we had technical questions or needed to upgrade as computer technology evolved.

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.