QualityHub has built its reputation as a world-class auditing organization.
We audit all products in the medical device industry and all areas of the Quality System. We audit device manufacturers and developers, pharmaceutical manufacturers, combination products developers and manufacturers, and bio-pharmaceutical manufacturers, as well as Clinical Investigator, IRBs and Sponsors. Geographically, we audit the US, Canada, Mexico, Central America, the Caribbean, Europe, Japan, China, Australia and New Zealand.
Whether your need is help with internal audits, or to do a comprehensive baseline audit of all your sites worldwide, QualityHub is equipped to handle the project. We’ve listed eleven (11) types of audits below to show that one size doesn’t fit all when it comes to audits.
At the beginning of many of our engagements QualityHub will provide Baseline Audits. Often these involve auditing many sites worldwide. For some clients these audits occur just after the client has received an FDA-483 or a Warning Letter. The purpose of these audits is to determine the overall health of the quality systems.
The FDA-483 or Warning Letter may only cite deficiencies in particular areas of the quality system; but the FDA expects companies to assess their entire quality system – not just those areas cited.
Often Baseline Audits are used before creation of the Compliance Master Plan so that the company will know which areas of the quality system need improvement and remediation.
Companies not cited by FDA with FDA-483s or Warning Letters should consider periodic Baseline Audits in order obtain an “independent” and thorough audit of their entire quality system.
QualityHub performs verification Audits for two purposes. The first purpose is to review and confirm that the progress made to the quality system against the QualityHub Baseline findings are adequate and compliant to FDA requirements and accepted industry practices. The second purpose is to review and confirm that the progress made against any FDA-483s and/or Warning Letters are adequate and compliant to FDA requirements and accepted industry practices.
QualityHub provides comprehensive audits following requests from FDA for Third Party Expert Audits. It is the practice of FDA to require such audits following Recidivist Warning Letters and also during Consent Decrees. In addition to providing the audits, QualityHub also provides the “Certification Letter” for the FDA. Often the FDA Warning Letter will call these “Outside Expert Consultant” Audits.
QSIT Medical Device Audits
QualityHub provides FDA-Style QSIT Audits. These audits can be conducted against the FDA’s Quality System Inspection Technique (QSIT), or they can be customized as necessary to only cover specific sections in QSIT. In addition to QSIT, QualityHub can also audit against Medical Device Single Audit Program (MDSAP), which is a newer FDA Inspection Guide – and also includes Supplier Controls.
These audits can be conducted as “hats on” or “hats on/off”, the latter of which provides some training on how to best respond to the QSIT Inspection questions.
QualityHub can help you meet the goals and objectives of your internal audit program. We understand that often your internal audit schedules are rigorous and difficult to achieve.
Some companies choose QualityHub to help with their internal audits when they fall behind on their audit schedule. Other companies choose QualityHub to help with their internal audits when they need specific auditor expertise.
QualityHub has auditors with expertise in virtually all areas of the quality system for Medical Devices and GMP for Pharmaceuticals, as well as Post Market Reporting requirements, Recall related requirements and Part 11. For example, areas such as Product Software, Computer System Validations, Risk Management or Design Controls may need someone with extensive background and deep experience.
Another reason to utilize QualityHub for internal audits is to provide a “fresh pair of eyes”. It should be obvious that if FDA has cited your organization with numerous quality system/GMP deficiencies, there is a good chance that your internal audit program is not getting the job done.
Supplier Controls are rapidly becoming a hot area for FDA compliance. More pressure exists today on companies’ Purchasing Departments to ensure their internal supplier processes are top notch. There is greater pressure to have high quality audits of suppliers. Often we short-change supplier audits by doing them too quickly, or by using auditors without the necessary depth of experience.
QualityHub can help you by performing audits of your suppliers, as well as your supplier processes. Our technical experts can help achieve the necessary depth of audit is that is needed. Our auditors have experience in a broad spectrum of technical supplier areas, ranging from contract manufacturers to component manufacturers.
Another means of auditing your quality system is to look at individual “systems” or processes individually. QualityHub provides Process Audits, which are also sometimes called “System” or “Sub-system” Audits. These audits are focused on key systems. Examples are CAPA, Design Controls, Risk Management, Process Validation and Complaint Management/MDR. Other areas of the quality system can be included as necessary.
The purpose of these audits is to review the objective evidence generated for these key areas of the Quality System. These Process Audits are often conducted using acceptance criteria, or using audit checklists, to provide consistency across the range of documents reviewed.
Your quality system documentation needs to be Inspection ready. These audits can help provide you with the comfort that the documentation is adequate and ready for FDA inspections.
Often a review is needed that is less formal than an audit. An Assessment is such a process. QualityHub can perform an Assessment of individual aspects of compliance or the Quality System, or an Assessment of a wide set of processes.
An Assessment can be as in-depth as necessary. Because the Assessment is conducted in a more informal manner than an Audit there may be more openness, which helps management gain a broader understanding of the situation. While an Assessment does result in a report, the Assessment Report is often not handled as an Audit Report. The Assessment may provide the look you are seeking, without the structure and stress of an official Audit.
FDA’s Bioresearch Monitoring program includes three distinct components. These are Clinical Investigators, Sponsors/CROs and Monitors, and Institutional Review Boards. QualityHub Clinical Audits will help determine compliance to the FDA requirements for all of these areas. We use auditors who have experience at FDA in the clinical area or auditors who are industry experts in the clinical area. The audits can be structured to sample clinical sites or be more all-inclusive. One benefit of independent third party audits is the fact that “fresh eyes” would be looking at the records. Knowing the auditors have expertise in the FDA’s Clinical requirements will help you know the level of compliance at the various sites.
It is not uncommon today to utilize an audit known as a Mock FDA Inspection prior to hosting an actual FDA Inspection. The audits cover any or all aspects of Device Quality System requirements or Pharmaceutical GMPs as well as a “Verification of Actions Taken” following an FDA 483 or Warning Letter.
These Mock Inspection Audits can be conducted as “hats on” or “hats on/off”. The latter of which provides real-time training to the organization on how to best respond to the FDA’s questions. The real-time feedback from “hats off” audits has proven very valuable to clients when FDA eventually inspected them.
The Mock Inspection Audit can also provide the organization with specific data on Subject Matter (SME) performance, Back-Room performance and inspection related logistics. This data is valuable in preparing the sites for the “Real FDA” Inspection. While these audits are not often in-depth enough to get a true reading of the entire Quality System, they have been known to provide the site with some indicators of items the agency may be concerned about in the “Real FDA” Inspection.
In the case where a new product could lead to an FDA Pre-Approval Inspection, QualityHub can perform a readiness audit. These audits often focus on a specific product and it’s related quality system elements. Specifically, it would cover documentation related to the product’s design controls (design history files), risk analysis and production and process controls to include process validation and related elements. In the case where FDA would be performing a Pre-Approval inspection we can cover the elements in FDA’s Inspection program. The audit can also serve as a rehearsal to prepare for the eventual FDA inspection.
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