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Audits to Ensure Your Organization is Fully Prepared

Our team is your dedicated partner, empowering you to navigate the complex landscape of audits with confidence.

 

Different Audit Services

Comply Guru offers a comprehensive range of audit services that span across a diverse spectrum of industry standards and regulations. Whether you’re in the Life Sciences, manufacturing, services, or any other industry, we tailor our services to your unique needs.

01 Internal Audits
Internal Audits are required at planned intervals to determine whether the Management System conforms to requirements of the given International Standard and/or applicable regulatory requirements, as well as ensuring it is effectively implemented and maintained. An internal audit performed impartially and externally by our team can be invaluable with advice and guidance provided for addressing gaps or making improvements.
02 Critical Supplier Audits
Need to audit a critical supplier? Short resources? Auditing suppliers, particularly in the Life Sciences, is an important task for Manufacturers to ensure that they have a strong supplier audit program. Our team can help with ensuring your suppliers are meeting relevant requirements, and help create and/or improve your supplier program.
03 Gap Analysis or Pre-Assessment Audits
If you are considering adopting an international standard, or have an upcoming official audit, our team can perform either a gap analysis or pre-assessment audit that will help you identify any gaps you need to address in advance, providing an experienced insight with advice for taking effective corrective action (if needed).
04 Unannounced Audits
Unannounced audits are nothing new, but if you would like to help prepare your site for an unannounced audit & assess your readiness, our team can help. Our Lead Auditors have a minimum of 15 years’ experience and can help you with specific, actionable advice to iron out any issues, so you and your company are ready for unannounced audits.
05 FDA Mock Audits
Are the FDA coming to inspect your facility? Our team can test your internal systems and personnel using Quality System Inspection Techniques (QSIT), and assess your cGMP, GLP, GCP, and QSR processes in advance to ensure you are ready.
06 Mentored/Coached Audits
New to auditing? Our team is available to offer mentored or coached audits (after or as part of training) where an experienced Lead Auditor can help you, or a team, prepare for and conduct an audit together to learn best practices and gain more practical experience while working side-by-side.

Our Team of Auditors

Comply Guru’s experienced team of Lead Auditors regularly train auditors for Regulators, Notified Bodies, Registrars & Certification Bodies, Consultants as well as Industry. Very few organizations in the world can say the same. Our team is available to provide a range of contract auditing services to help you or your company. Get in touch with us today to discuss your needs!

QA/RA Director Michelle Keane
MD-QMS Lead Auditor Tess Egan
QEHS Lead Auditor Kristian Hill

Contact us today to discuss your auditing needs

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CQI & IRCA Approved Training Provider

CQI & IRCA Approved Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020