| Zorich Technical Consulting & Publishing | ||||||||||||||||||||||||
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| 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. | ||||||||||||||||||||||||
| About Us | ||||||||||||||||||||||||
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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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| 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. |
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