Quigley Compliance Associates
Quigley Compliance Associates is a life science compliance consulting firm headquartered in the Bay Area, supporting pharmaceutical, med device, and biotech clients nationwide. They specialize in compliance and validation throughout the entire project lifecycle, offering customized solutions to meet the rigorous demands of the ever-changing life sciences industry. Their team of knowledgeable consultants ensures no detail is overlooked, helping clients meet compliance requirements efficiently and effectively.
Industries
Nr. of Employees
small (1-50)
Quigley Compliance Associates
Burlingame, California, United States, North America
Services
Management of schedules, contractors and project budgets; provision of project managers and administrative support for life-science projects from inception to completion.
Customized validation planning and execution for facilities, utilities, process and analytical equipment, cleaning processes, controlled temperature units, automation and computer systems.
Planned and documented commissioning services for facility systems and equipment to verify technical operation and support turnover to end users.
Qualification and validation services for refrigerators, freezers (including cryogenic ranges), incubators, cold rooms and stability chambers, including evaluation of monitoring systems and data logger compliance.
Creation and maintenance of SOPs, preventative maintenance plans, user requirement specifications and calibration program documentation to support reliable operations and compliance.
Support for design, commissioning and qualification of clean rooms, HVAC, gas distribution, purified water systems and laboratory/building monitoring systems.
Management of schedules, contractors and project budgets; provision of project managers and administrative support for life-science projects from inception to completion.
Customized validation planning and execution for facilities, utilities, process and analytical equipment, cleaning processes, controlled temperature units, automation and computer systems.
Planned and documented commissioning services for facility systems and equipment to verify technical operation and support turnover to end users.
Qualification and validation services for refrigerators, freezers (including cryogenic ranges), incubators, cold rooms and stability chambers, including evaluation of monitoring systems and data logger compliance.
Creation and maintenance of SOPs, preventative maintenance plans, user requirement specifications and calibration program documentation to support reliable operations and compliance.
Support for design, commissioning and qualification of clean rooms, HVAC, gas distribution, purified water systems and laboratory/building monitoring systems.
Expertise Areas
- Validation lifecycle management
- Commissioning and qualification
- Controlled temperature equipment validation
- Facilities and utilities qualification
Key Technologies
- Validation master planning and risk-based validation
- User Requirements Specification (URS) and functional/design specifications
- Pre-functional and functional testing checklists
- P&ID walkdowns and system redline management