Audits to Ensure Your Organization is Fully Prepared

Our lead auditors can be your dedicated partner, helping your organization navigate the complex landscape of regulations and industry standards with confidence.

Need an Experienced Lead Auditor? We can help.

Comply Guru have an experienced team of Lead Auditors available to perform a range of contract audit services across a diverse spectrum of industry standards and regulations. Whether you’re operating in the Life Sciences, Manufacturing, Services, or any other Industry, our auditors can help with internal audits, gap assessments, supplier audits and more. Get in touch with one of our experts today to schedule a free consultation!

Internal Audits
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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.
Critical Supplier Audits
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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.
Gap Analysis or Pre-Assessment Audits
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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).
Unannounced Audits
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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.
FDA Mock Audits
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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.
Mentored/Coached Audits
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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 Lead 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

Ready to take your audits to the next level?

Schedule a free consultation to learn how Comply Guru can help.

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