Zorich Technical Consulting & Publishing
Quality Systems
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We help clients install & maintain quality systems that minimize the amount of paperwork, training, and disruption to R&D and Manufacturing while still meeting regulatory requirements, business needs, & employee desires for short, simple procedures.
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Our services are provided on an hourly basis, and we pride ourselves on being able to establish and implement systems in days and weeks, not months.
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Safety
Our services can include one or more of the following:
          • initial assesment of your situation (and on-going consultation, if desired)
          • internal audit (on an on-going basis, if desired) vs. the requirements
             of ISO 9001, ISO 13485, cGMP = 21CFR820 = "QSR", MDD, IVDD, and
             the Canadian MDR
          • training
          • quality system development (Quality Manual, SOPs, Forms; in addition,
             we provide Excel spreadsheets to organize & greatly simplify early-stage
             quality system tasks, such as Document Control, CAPA, NCMR, Inventory
             Control, Lot# issuance, Equipment Calibration & Maintenance, Rework,
             and Approved Supplier List)
          • help interacting with regulatory agencies.

To download a demo copy of our quality system template Quality Manual, Forms, and Logs, mouse-click here.
Prop 65
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