Design review, IQ, OQ and PQ for 9,500 sq.ft. cleanroom used for sterile device assembly
Autoclave IQ, OQ, cycle development and PQ for GMP media prep autoclave
We provide validation services of all types to the regulated industries: drugs, biologics and medical devices. We write and execute protocols for all systems, equipment and processes.
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We can help develop and implement regulatory-compliant programs to assure product quality and batch-to-batch uniformity. We have experience with labeling, metrology and environmental monitoring.
We have substantial experience providing GMP training to employees. Our free newsletter is an extension of this service and an indication of our knowledge and capabilities.
We can provide technical training on a variety of topics, including steam sterilization, process validation and protocol development. We customize our presentations for your workforce.
We can help your company comply with GMPs. We have experience writing SOPs and master batch records. We can audit facilities, vendors and operations and offer suggestions for improvement.
We can review facility and equipment designs to verify regulatory compliance. We can prepare validation master plans and manage validation and other projects on your behalf.
Sample presentations you can download
Important information about our company
(781) 698-9215 (mobile)
Westerly, RI 02891 USA