Simple Quality Systems
quality processes made easier!
Boutique QA fractional consulting practice located in Philadelphia, a hub for cell and gene therapies innovation!
Simple Quality Systems is built on more than 25 years of experience in QA and Quality Operations, to provide straightforward, efficient, and simple quality solutions for biotech and startups.
Whether you need help with completing just one vendor audit, or something more complex like building your whole QMS, we can help!
LAUNCHING SOON!!
Request a free consultation
Has your company setup the proper quality foundations to better navigate the clinical journey?
'WE ARE CELLICON VALLEY'
Philadelphia has become a hub for science innovation in cell and gene therapy. With a myriad of new biotech and startups launching, it has become a common theme to delay setting up a QA organization or quality systems until clinical trials are underway. Establishing the quality foundation from the start is crucial for better engagement and to enforce a culture of quality from the top down.
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Simple Quality Systems provides quality support at any stage of the clinical journey, whether is helping select, audit, and qualify GxP vendors at the very early stages, or supporting already established quality workstreams like internal auditing, managing deviations and CAPAs, re-qualification audits, risk assessment, or change management.
The goal at Simple Quality Systems is to create dedicated solutions around YOU so your teams stay focused on their research, development & translational activities. We can help develop a fit-for-purpose quality plan tailored to your needs and timelines!
Current Services
Below are some examples of the services offered - We offer fractional consulting or hourly support! Please contact us for additional information.
Vendor Management
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GxP Vendor Audit(s)
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Vendor selection and qualification
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Vendor Risk Assessment
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Author/Review of Quality Agreements
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Develop SOPs/Templates
Training
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Build a training program (manual, eQMS)
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Provide workshops in quality topics
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Assess state of compliance of existing training program
QMS Management
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Develop a fit-for-purpose QMS
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Gap assessment of existing QMS
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Provide annual GxP Training
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Develop Change Mgt process
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eQMS implementation
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Design Quality Council, Quality Review Board, KPIs
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Support accreditation (FACT, ISO, CAP, etc.)
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Laboratory Services
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Analyst certification program
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Develop Lab QMS
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Good Laboratory Practices
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Good Documentation Practices
General Auditing
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Internal/External Audits
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Vendor Audits (GMP, GLP, GCLP)
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Develop audit program/schedule
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Train staff to prepare for an inspection
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Conduct a mock audit
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Train staff to conduct internal audits
Other......
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Fully Bilingual - services/documents can be provided in Spanish if needed
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Global and International capabilities
Suzette Arostegui, M.S.
Owner
"I am a true believer that GxP quality management systems can be designed to be simple! Why some QA processes are created to become these untamable monsters is beyond me. After 25+ years supporting quality organizations in pharma and biotech, I have learned how to be LEAN when developing and improving quality processes.
My consulting practice has one area to focus on: Help biotech organizations entering the space, setup fit-for-purpose GxP quality systems. That’s it. SIMPLE.
I look for ways to take the complexities away and deliver simple and straightforward quality solutions, not only easier to follow but also easier to maintain (i.e., absolutely critical if your organization is at the pre-clinical or early clinical stages!). I follow a pragmatic approach to quality while ensuring compliance is maintained, avoiding creating convoluted QMS processes that nobody will understand, let alone follow!
LAUNCH COMING SOON!
Our practice is expected to launch sometime by the end of the year. As we build our programs and services, please join our email list to get notified when when we GO LIVE, as well when new content is uploaded (i.e., training materials, templates, webinars, etc.)
STAY TUNED!