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Microscope to demonstrate audit focus

AUDITING

Regulatory Mock/Preparation Audits:

While audits against domestic and international regulations, along with international standards, are routine in the pharmaceutical and medical device industries, the readiness activities within each company vary. Developing a risk-based approach to audits allows companies to maintain a competitive edge while meeting international quality and government compliance standards. In the absence of such preparation, companies are risking non-compliance that can result in a failure to obtain necessary certifications; delayed facility registrations and product approvals; recalls; and regulatory actions including warning letters or consent decrees. One of the best ways to prevent such situations is to conduct mock audits to review facility and quality system compliance prior to a visit from a regulatory or notified body. Quality Confidential mock audits increase company readiness by:

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  • Assisting companies in the identification of topics that will be the most scrutinized

  • Establishing smooth processes for documentation retrieval, management, and reconciliation (War Room 5S)

  • Coaching employees on what to expect and how to behave with investigators

  • Identifying compliance issues and deviations early allowing for strategy development and pre-audit remediation

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Quality Confidential auditors have years of experience hosting domestic and international regulatory and notified body audits. We help our clients identify and remediate facility and quality compliance weaknesses before they become formal observations while coaching employees through the audit process. We can also be on-site during hosted audits (PAI, Regulatory, NB) to assist with presentation preparation, pre-entry document review, and request interpretation.

Internal Audits:

A survey of our clients revealed that the two most frequent difficulties in conducting internal audits are:

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  • Ensuring that the audit is truly “independent” of the department being audited

  • Identifying qualified personnel within the organization to perform the audit.

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Although large organizations often have an independent audit department or management function, most small-to- medium-sized organizations do not. As such, internal audits are often performed by employees with full-time responsibilities in other departments, who are not Subject Matter Experts (SMEs) in the topics being audited. This can lead to not identifying complex compliance issues and risks or failing to support company objectives through the identification of continuous improvement opportunities.

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At Quality Confidential, we have developed and implemented internal audit programs globally. We have a team of qualified auditors and highly specialized SMEs that are available to assist with your internal audit needs. These experts know how to manage every aspect of the internal audit program including:

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  • Audit program development or remediation

  • Identification of audit metrics to support objectives

  • Annual audit schedule development and tracking

  • Audit planning, execution, report writing, and follow-up

Supplier Qualification Audits:

Supply Chain Management is critical to ensuring production efficiency and continued supply to patients for both clinical and commercial organizations. Supplier Qualification Audits are a key component for monitoring internal (site-to-site) and external suppliers as well as establishing the organization’s Approved Supplier List (ASL). A robust program will confirm that a supplier can deliver the service or material on time, according to company specifications, and in alignment with the regulatory expectations for the product market(s).

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Quality Confidential manages both individual supplier quality audits and supplier audit programs for our clients. Our consultants perform both desk-top and on-site audits and can provide assistance with the development of Supplier Quality Agreements during the initial qualification process.

For-Cause Supplier Audits:

Despite the existence of a robust supplier qualification process, there are times where things don’t go as planned. Problems may arise at supplier locations during manufacturing, testing, or shipment that result in damage or loss of product. Companies often need a focused individual or group to act as a liaison with the supplier site to resolve the problem. At Quality Confidential, we see problems as opportunities. Our auditors and consultants provide objective oversight to the audit/investigation process, delivering concrete, non-biased results and practical recommendations for resolution.

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