Customized Compliance Solutions.
Headquartered in the Bay Area and supporting projects nationwide, Quigley Compliance Associates services pharmaceutical, med device, and biotech clients from coast to coast.
From project inception to close, we specialize in compliance within the life science fields. Whether you’re a scientist or engineer, director in an enterprise or run a startup; we are here to consult and help ensure your compliance and regulatory requirements meet the rigorous demands of the ever changing life sciences world.
We bring extensive experience and professionalism to every project and customize our support to your individual needs and concerns. Our consultants are knowledgeable about regulatory specifications of the life sciences industry.
Here at Quigley Compliance Associates, we pride ourselves on adopting a whole life-cycle approach to compliance and validation. By strategically planning projects with our client, we ensure no small details will go unnoticed.
Let us help you meet the ever-changing world of compliance with customized solutions for all your needs.
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Redwood City, CA
Compliance Life Cycle
Regulatory organizations and agencies require compliance throughout the whole life cycle of a project. From project inception to project completion, at QCA we're here to help you complete your project and maintain compliance, all while remaining budget conscience. With QCAs extensive experience we can provide teams or individuals to compliment your group or organization by leading projects, or through assisting your existing teams in meeting milestones.
QCA uses a risk based approach leveraging client specifications to generate comprehensive qualification documents and protocols. Using this method followed by validation master planning, allows QCA to provide a complete validation program customized for your specific needs as a client.
Whether you are renovating an existing facility or building a new one from scratch, the finished product will only be as good as the foundation it was built on. From small-scale, single room builds to large construction projects, let QCA help guide you through the design, commissioning, and validation processes. We will work to leverage documentation in a streamlined manner that will save you money and time while ensuring your regulatory and internal requirements are satisfied.
facilities, process, procedure documentation
QCA has experience working with both small and large companies and possesses extensive knowledge of a variety of quality systems. QCA can provide consultants to help build on existing quality programs or help institute new quality systems including preventative maintenance, corrective action and preventive action plans and operating procedures.
Controlled temperature Units
Freezers, refrigerators, and incubators are standard pieces of equipment found in research labs, manufacturing facilities, and GxP storage facilities. These CTUs are also one of the most common sources of non-conformance letters and 483s. QCA can easily team up and collaborate with clients on site to audit current CTU programs, assist in generation of protocols, and provide specialists to assist in execution of existing client documentation. Fill out this form to tell us more about your CTU validation needs.
No matter the size or the needs of your project, QCA has the experience required to assist you and ensure your project stays on schedule. From full site validation projects, to commissioning and installation projects, or technology transfer, QCA can maintain schedules, budgets, and personnel requirements for the duration of the project.
Use the form below to contact us regarding your compliance needs. Please be as detailed as possible. Include your industry along with any specific document requests. To help us best service your inquiry, we recommend that you first describe the issue you’re having before telling us what you want to achieve. You may also email or call us to make an appointment.
For job opportunities, please email us your resume. We’re always looking for new and exceptional talent.