Quality Management System due diligence is an important part of any pharmaceutical quality management system. It helps to ensure that the system is fit for purpose and compliant with relevant regulations. The requirements of the pharmaceutical quality system are summarized in ICH Q10, a European guidance that has acceptance in the U.S. with the […]
Compliance Team is an efficient, core group of engineers, scientists, regulatory and quality experts who care about protecting your investment in R&D, IP and business operations.
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Your team [Compliance Team] helped us build a streamlined, and compliant Quality System Manual. You assured our company was meeting both ISO and FDA standards. Compliance Team was an asset to our team during the ISO 13485 audit. Because of [Compliance Team's] your guidance and attention to detail, we obtained ISO 13485 certification and we were able to expand our medical device manufacturing services and customer base.
"The Compliance Team group has been instrumental in helping us with all aspects of our compliance to 21 CFR part 820 and part 11. We sincerely appreciate their level of expertise, their patience and their integrity as they guided us through interpretation of the medical device and data integrity regulations. I would recommend them to anyone needing practical advice on these topics."
Anita, Regional Director of Quality
“…Compliance Team was credited for having the flexibility to understand the repercussions of various risk-based options, assuring qualification coverage via a less-restrictive method.”
“Compliance Team was also instrumental in authoring the Quality Plan, a Validation Master Plan, Validation Plans, Validation Risk Assessments, and the Validation Project Plan for all of these systems…”
Thanks again for all your help, we hope to continue working with Regina as much as we can, she has been a perfect fit for us.
Jamie O’NeilCEO, Electroskip
Less Risk and Complexity Brings Peace of Mind
Since 2003, we have protected over 200 life science companies by assuring their quality systems, engineering validation programs and clinical studies consistently meet compliance standards. Our knowledge of FDA, ISO, EMA, Health Canada, and other regulating bodies secures you and your customers from costly regulatory and compliance oversights.
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Regulatory and Compliance Resources
Medical devices are becoming increasingly interconnected, so they are more vulnerable to cyberattacks. To ensure the safety and effectiveness of medical devices, it is important that medical device manufacturers understand the various cybersecurity standards applicable to their products. In this blog post, we discuss: The regulatory standards for medical device cybersecurity in the United […]
FDA CAPA Expectations and How to Build Great CAPAs Session Objectives:• Provide an overview of FDA expectations for CAPA/investigation compliance• Compare and contrast an effective CAPA from an ineffective CAPA program• Help you identify CAPA tweaks that add business value in your workplace.• Help build your knowledge, and answer questions so you become a CAPA […]
Michelle Bonn, President and CEO of Compliance Team, recently attended the DA4S East Coast Conference. The conference was held in Newark, NJ from May
Compliance Team is pleased to announce our strategic partnership with ComplianceQuest. ComplianceQuest provides solutions for documentation and
Michelle Bonn, President and CEO of Compliance Team, was presented the MedTech Association's 2021 Groundbreaker Award on January 13th at the del Lago