ENGAGEMENTS
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REGULATORY & COMPLIANCE CONSULTING
Cynet Systems has established a vast national network of quality, validation and compliance experts as well a front-line managers.
They share expertise in their fields and they come from a wide range of industries.
Our R&C engineering consultants’ expertise includes the following:
• Quality Systems Development: Complaint Management, Deviation Management, CAPA, Change Control, Training, Document Management, Control
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• Quality Assurance & Quality Engineering
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• Methodology, Policy and Procedure Development
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• Gap/Risk Assessment
• Computer Systems, Software, Process, Cleaning, Methods, Facilities & Utilities, Equipment, IT Infrastructure, 21 CFR Part 11
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• Compliance Auditing: Applicable Regulations, Guidelines,Procedures & Policies for Part 11,
Quality Systems, Vendors, IT Compliance
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• MDRs and Complaint Handling
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• Recalls
• Regulatory Affairs: Writing Submissions, Documentation and Remediation including 501k Submissions, AERs, PMAs, IDE, Remediation/Resolution Management, Technical Papers, Complaint Handling
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• Validation: Developing Standard Operating Procedures (SOPs), Validation Support Processes (VSPs), Validation Protocols (IQ, QQ, PQ) Validation Master Plans, Validation Executions, Validation Report Writing
Contact Cynet Systems today to find out how our R&C engineering consulting services can help your company succeed. At Cynet Systems, we provide simple staffing solutions for a complex world.