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Quality Policy
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Design History File Maintenance
Product Verification & Validation
Product Specification
Design Transfer
Software Development Life Cycle Process Templates
Test Method Qualification
Software Development Plan
Software Requirement Specification Development
Software Design Specification Development
Software Coding Standards
Software Testing Methods
Software Requirements Traceability Matrix
Software Installation Qualification
Software Backup & Retention
Software Configuration Control
Document & Change Control
Document & Change Control Process
DMR Creation & Revision
QSR Index Creation & Revision
Creation & Revision of Drawings
Records Control
Good Documentation Practices
Electronic Records Control
Device History Record Maintenance
Purchasing Control
Supplier Management
Supplier Auditing
Supplier Focus Database Maintenance
Component Supplier Audit Checklist
Service Supplier Audit Checklist
Software Supplier Audit Checklist
Identification & Traceability
Label Control
Acceptance Activities
Handling & Storage and Distribution
Production & Process Control
Process Validation
Statistical Techniques
Nonconforming Material
Corrective & Preventive Action
CAPA Process Model
Complaint Handling Process
Complaint Handling
Inspection, Test & Measuring Equipment
Calibration
Equipment & Facilities Control
Preventative Maintenance
Preliminary Hazard Analysis (Top Down Analysis)
Product Development Plan
Product Requirements Document (includes SRS & SDS)
Design FMEA
Software Risk Analysis
Validation Protocol & Reports
Design Transfer Plan
Process FMEA
Manufacturing SOPs
QA/QC Procedures (Acceptance Activities)
Installation and Servicing SOPs
Bill of Materials (BOM)
Device Master Record
Manufacturing Equipment SOPs
Training Requirements
IQ/OQ/PQ Protocols & Reports
Design & Phase Review Records
Design Planning
Concept & Feasibility Request Form
Feasibility Analysis Template
Market Requirements Document
Product Requirements Specifications
System Architectural Specifications
Product Development Plan
Software Development Plan
Quality Plan
Regulatory Plan
Service Plan
Design History File Index
Risk Analysis
Risk (Hazard) Analysis
Fault Tree Analysis
Application FMEA
Component FMEA
Software FMEA
Process FMEA
Design Review
Design Review Meeting Minutes Template
Technical Design Review Form
Concept & Feasibility Phase Review
Design Planning Phase Review
Design/Development/Verification Phase Review
Design Transfer Piot Production Phase Review
Design Validation Phase Review
Production Phase Review
Design Verification & Validation
Verification & Validation Plan
Verification Protocol (Generic)
Verification Report (Generic)
Traceability Matrix
Simulated Use Testing Protocol (will used generic verification protocol)
Clinical Trial Protocol
User Preference Testing Protocol
Design Transfer
Design Transfer Checklist
Design Transfer Plan
Equipment Specifications
Facilities/Utilities Specifications
Tooling Specifications (Use existing drawings)
Material Specifications (use existing drawings)
Factory Acceptance Testing Protocol & Report
Site Acceptance Testing Protocol & Report (Use FAT)
Electrical Subsystem Development
Electronic Requirement Specifications
Electronic Detail Design Description
Mean Time Between Failure Report
Derating Protocol
Derating Report
Electronic Test Requirements
Electronic Subsystem Reliability Protocol
Electronic Subsystem Reliability Report
Electronic Subsystem Functional Verification Protocol
Electronic Subsystem Functional Verification Report
Electronic Subsystem Environmental Verification Protocol
Electronic Subsystem Environmental Verification Report
Electronic Subsystem Safety Verification Protocol
Electronic Subsystem Safety Verification Report
Mechanical Subsystem Development
Mechnical Requirement Specifications
Mechanical Detail Design Description
Control Algorithm Architectural Report
Life Cycle Testing Verification Protocol
Life Cycle Testing Verification Report
Mechnical Subsystem Design Verification Protocol
Mechnical Subsystem Design Verification Report
Biocompatibility - Sterility Verification Protocol
Biocompatibility - Sterility Verification Report
Software Subsystem Development
Software Change Request
Software Requirements Specification Review Checklist
Software Architectural & Detail Design Specifications Review Checklist
Code Review Checklist
Software Configuration Management Plan
Software Requirement Specification
Software Architectural & Detail Design Specifications
Software Traceability Matrix
Unit Testing Protocol
Integration Testing Protocol
System Level Black Box Testing Protocol
Software Configuration Management
Software Backup, Retention & Recovery
Software Issue Tracking & Management
Labeling Subsystem Development
Labeling Approval
Labeling Requirements Document
Installation Instructions
OEM Labeling (addressed in the LRS)
Operator's Manual
Service Manual
Illustrations (addressed in the LRS)
Dealer Labels (adressed in the LRS)
Packaging Development - (Determined don't need)
Packaging Verification Protocol (Determined don't need)
Packaging Verification Report (Determined don't need)
Process Validation
Installation Qualification Protocol
Operational Qualification Protocol
Performance Qualification Protocol
Generic Qualification Report
Test Method Qualification Protocol


Coming soon and currently under development are Templates, Forms, SOPs and Software Solutions for your Engineering and Regulatory Compliance Needs



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