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Capabilities
Audits
Corrective Action & Remediation Plans
Quality System Implementation & Improvement
Validation
Software Development Lifecycle
Risk Management
Organizational Development
Failure Investigation & Problem Solving
Training
Regulatory Solutions
510K/PMA
Site Registration
Device Registration
FDA 483 and Warning Letter Responses
Strategic Solutions for FDA 483, Warning Letters,
Consent Decree, Import Alerts etc.


The following is a list of BEQS Capabilities. BEQS continues to expand its services with the intention of becoming a world leader in Engineering and Quality Assurance consulting for the Medical Products Development and Manufacturing industry.


Management Solutions

Engineering Solutions

Audits
  • Mock FDA Audits (including QSIT)
  • Internal Quality System Audits
  • Supplier Audits
  • Due Diligence Audits
Per request, each audit may include an Audit Plan, Audit Report, Daily Briefings, and Corrective Action Plan. Upon request, Audits may be conducted by ex-FDA or Industry personnel, or a combination thereof. Audits may include BEQS administrative and/or management support.
  • Corrective Action & Remediation Plans
  • 483 & Warning Letter Responses
  • Audit Reports
  • Quality System Implementation & Improvement
  • Comprehensive or sub-system specific assessments
  • Team approach to conducting gap analysis, benchmarking, design and implementation of improved sub-systems.
  • Comprehensive Training on new or improved sub-systems
  • Training on supporting topics (Regulations, Writing, Problem Solving, Validation etc.)
  • Validation
  • Equipment & Process Validation
  • Software Validation
  • Gage R&R
  • Software Development Lifecycle
  • Design and Implementation of SDLC process
  • Software as a Medical Device
  • Software as part of the Quality System
  • Automated Processes for Manufacturing
  • Part 11
  • Risk Management
  • Risk based systems for:
  • CAPA (including Product Complaint Handling)
  • Product Development
  • Change Control
  • Validation
  • Organizational Development
  • Organizational Development for Quality System Implementation
  • Conflict Management
  • Communications Skills
  • Change Management
  • Failure Investigation & Problem Solving
  • Problem Solving, Decision Making
  • Product Complaint Investigations
  • CAPA
  • Training
  • 21 CFR Part 820, 210, 211, 11 and predicate rules
  • Quality System
  • CAPA
  • Design Controls
  • Management Controls
  • Production & Process Controls
  • Facility & Equipment Controls
  • Purchasing Controls
  • Laboratory Controls
  • Document & Record Controls
  • Validation
  • Equipment & Process Validation
  • Software Validation
  • Regulatory Solutions
  • 510K/PMA
  • Site Registration
  • Device Registration
  • FDA 483 and Warning Letter Responses
  • Strategic Solutions for FDA 483, Warning Letters, Consent Decree, Import Alerts etc.

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