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REGULATORY SERVICES: Quality System
QUALITY_SYSTEM
STANDARDS
DESIGN_CONTROL
RISK_MANAGEMENT
SYSTEM_MODELING
REQUIREMENTS
DESIGN_DESCRIPTION
UNIT_TESTS
VERIFICATION
VALIDATION
TRACEABILITY
AUTOMATED_V&V
Syprosoft Engineering has helped many clients implement or update their quality system processes to comply with the latest governmental requirements. Even a small start-up has to have a quality system that is compliant with the regulations. Syprosoft Engineering can put together a system that is customized to the client’s operations and that adds no extra burdens or only minimally so. Below is the top-level organization chart for a small medical device company with outsourced manufacturing that we developed the quality system for.

  • The quality system typically includes the following processes:
  • Quality System Requirements
  • Design Controls
  • Document Control
  • Purchasing Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance Activities
  • Nonconforming Product
  • Corrective and Preventive Action
  • Labeling and Packaging Control
  • Handling, Storage, Distribution & Installation
  • Records
  • Servicing
  • Statistical Techniques
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Contacts: (1) Henry Bryson, VP hbryson@syprosoft.com (949) 250-1065 x121 (2) Dipu Ghosh, President dghosh@syprosoft.com (949) 250-1065 x124
Syprosoft Inc. 1200 Main Street, Suite B Irvine, CA 92614, USA (949) 250-1065 www.syprosoft.com
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