Supplier Audits

Why Synergy Bioscience for GXP Audit Solutions?

If your current internal audit program consists of employees tied to your organization ₋₋your internal audit has already failed. It is virtually impossible for an in-house auditor to take a neutral position when auditing their own organization’s departments or processes. As a result, you may find the internal audit reports continue to come out clean time after time,until the FDA visits your facility. This is when you finally realize your internal audit program was sorely ineffective. Sadly, this discovery will occur too late and be costly for your organization. With Synergy Bioscience’s top notch certified auditors, you can avoid the disappointment of an ineffective internal audit program, and be guaranteed to receive an audit that will ensure a perfect FDA inspection outcome.

Your Quality Management System (QMS) is the foundation and the bedrock upon which everything else involved with your Quality program is derived. Without a well-designed, compliant, and sustainable QMS, it is impossible to consistently produce a high-quality product or guarantee regulatory compliance.

Quality audits can be extremely beneficial when performed correctly and in a timely manner. They can help you “find and fix” problems as you discover them, rather than waiting until you are formally notified by regulatory authorities.

Synergy Bioscience’s team of former regulatory inspectors and industry experts can assist you by performing audits to any current standard for production, packing, engineering, software, water systems, autoclaves, raw material suppliers and supplier services.

Synergy Bioscience is the leader in identifying weakness and areas of improvement – and will recommend solutions to address deficiencies. Our comprehensive and detailed audit reporting serves as the basis for a site-wide corrective action plan to remediate deficiencies, while creating a more robust and sustainable QMS.

Quality audits are intended to achieve multiple goals and benefits.

Our experience in conducting baseline audits working with scores of clients to remedy weaknesses in their QMS in pursuit of creating a compliant practical and sustainable system.

Synergy Bioscience’s Management System Team of experienced former regulators and industry professionals are experts at performing in-depth assessments of your QMS against the latest regulatory requirements and industry best practices.

Synergy Bioscience’s guarantee to you is compliance readiness, whether for an FDA inspection, overseeing a preapproval inspection, internal audit, ISO audit or vendor qualification audit, or to simply prepare a regulatory submission that will pass muster with the agency and its critical reviewers.

Synergy Bioscience can assess any type of activity against all major national or international standards including: EU, USA, Canada, Australia, WHO and others. We provide pragmatic advice on how to achieve compliance (not just tell you where you fail to comply) in a cost-effective manner.

Whether it isa Quality System Audit for a GMP work environment, a Clinical Trial Audit,or a Laboratory Operation Audit, Synergy Bioscience provides comprehensive GXP compliance and regulatory consulting services across all disciplines of the Pharmaceutical, Medical Device, and Biotechnology Industries, helping clients leverage compliance for competitive advantage.

If you are searching for an in-depth expert assessment of a specific technical issue, or to outsource your entire supplier audit program, Synergy Bioscience can handle the project.

To discuss how Synergy Bioscience can help you, please contact us