Chimera TQM Services
Chimera TQM offers a comprehensive set of remote and onsite Quality Management Services addressing the needs of Programs big and small.
We will help ensure that your Program meets or exceeds regulatory and accreditation requirements. We can supplement your existing quality team or provide more comprehensive support, as needed.
Let our experienced Quality Managers handle the details.
Our Services
A sampling of our services -
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Monitoring for changes to regulatory or accreditation requirements
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Staff Training in GTP
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Advising/mentoring of new staff
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Setting up a Quality Management Plan
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Auditing services - as part of your team or as an independent auditor
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Document review as a interim Quality Manager for staff on leave
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Reviewing Quality Management Plan and supporting documents in preparation for accreditation or remediation after inspections
Our Process
We want to make sure that we’re a good fit before committing to a project, so we’re happy to discuss your needs first. In general, if your site is a collection center (apheresis or bone marrow) or a processing facility, especially at an academic institution, we will likely be familiar with the requirements surrounding your activities, but a quick call is the best way to determine if we can help.
We have both long-term and short-term clients, so no project is too small. If you’d like something as small as a review of a document, we can accommodate you. Otherwise, we charge only for the amount of work that is completed, and are happy to shift gears in the middle of a project to increase or decrease the amount of effort spent on a particular challenge.
(Feel free to browse our selection of SOP and other documents available for purchase prior to engaging us with a full contract. Each SOP purchase also provides you with up to two hours of revision and/or discussion based on your needs)
Initiating A Project
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Contact us to let us know how we can help you. Please describe, in general terms, what your team may be struggling with. If an NDA is needed, no problem.
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Once we’ve reviewed your project, we’ll schedule a free 30 minute call to discuss your needs and our expertise.
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If there is a good fit and no conflict of interest, we’ll then Discuss Contract Terms, including:
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Quote for hours and rate
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Propose a project plan
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Determine which entity supplies the contract
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​We’ll provide a Statement of Work detailing the phases of the project as understood from the call, with expectations and deliverables.
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Once the contract is signed, our first step is usually a gap analysis - what you do have - in a quality plan, in an SOP or in a validation - and what should you have.