PharmaSeq

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Quality Control

Currently PharmaSeq either produces products itself or closely supervises each step in the manufacturing process. p-Chips are currently made in silicon foundries with the Company directing each step in post-processing, while ID readers, both hand-held and flow-based, are made in-house. Similarly, all consumables including small animal p-Chip injectors and diagnostic reagent kits are made on premises but can be outsourced when volumes reach appropriate scale. The Company has access to a number of local specialty companies in the area.

In 2011 PharmaSeq instituted a formal Quality Management System (QMS) that is actively being used to design, build, test and support its commercial products. The QMS includes standard operating procedures, bills-of-materials, customer support and other modules that will be the basis of applying for ISO 9002 (tagging) and ISO 13485 (diagnostics) certification. Every employee of the Company has received training and actively uses the system in his/her workflow. Periodic quality audits are also conducted.

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