PharmaSys has extensive experience and expertise with Good Manufacturing Practices, Good Lab Practices and Good Clinical Practices. Our auditors have experience in a variety of operations, from aseptic fill to blood fractionization. PharmaSys began as computer validation firm and remains a leader in the field.
We can assess your computer systems, or proposed computer system, against predicate rules (cGMP, GCP, GLP), GAMP and Part 11 then make sound recommendations for compliance. PharmaSys provides remediation services for consent decrees, warning letters, FDA 483 observations, and customer generated compliance events.
We can assess your computer systems, or proposed computer system, against predicate rules (cGMP, GCP, GLP), GAMP and Part 11 then make sound recommendations for compliance. PharmaSys provides remediation services for consent decrees, warning letters, FDA 483 observations, and customer generated compliance events.
Services
PharmaSys, Inc., a respected biopharmaceutical compliance consulting company local to the RTP area, is growing and seeking experienced, motivated people with entrepreneurial spirit to join our winning team. Successful applicants will provide technical and validation support services to a variety of biotech, medical device, pharmaceutical, and clinical companies.
Our professional auditors have extensive experience in their respective fields and are available to fly anywhere in the world at a moment's notice. PharmaSys had an audit team onsite within days of our request. They were instrumental in the timely review of our clinical data allowing us to complete our NDA in record time.
PharmaSys has extensive experience in developing and executing cleaning validation programs in multi-product facilities. We understand the challenges of ensuring a consistent and effective cleaning program in high throughput facilities. Cleaning validation ensures that specific cleaning processes consistently clean residuals to pre-defined limits of acceptability (product or cleaning chemistry related) based on a scientifically based methodology.
We provide commissioning, start-up and qualification services for production facilities, including utilities, process equipment and control systems. Our projects have ranged from single systems to major renovations/expansions to complete biotech and pharmaceutical facilities. By utilizing the risk based approach outlined in ASTM E 2500, we can successfully leverage vendor documentation for much of the validation.
PharmaSys began as a computer validation firm and is considered to be a world leader in this field. From assessment and planning to execution and reporting, we can reduce your computer validation compliance burden. Computer validation services may be provided a la carte or as a turn-key solution including project management as required by the client.
Reviews
Be the first to review Pharmasys.
Write a Review
