Overview of Quality System Auditing
QualityHub has extensive experience in performing quality system auditing for medical device, drug, biologic and combination product manufacturers who operate in a globally regulated environment. Our highly skilled auditors are carefully selected based on technical capabilities, audit experience and product knowledge to ensure the audit experience is both effective and efficient.
Many of our auditors are former FDA investigators with an excellent ability to interpret and apply regulatory requirements to complex products. We can provide compliance audits, gap assessments and technical reviews in all FDA and EU MDR regulated areas that concurrently address global regulatory requirements.
Whether your organization needs assistance in preparing for your first FDA inspection, post-inspection certification audits, supplier audits or support in executing worldwide internal audits, QualityHub is the only call you need to make.
For more information about our unique and customizable audit programs, please review the nine types of audits below.
We can perform comprehensive audits of your quality system worldwide or just selected sites. These audits typically determine compliance with FDA and ISO requirements.
In addition to auditing manufacturing sites, we also audit:
- Design Centers
- Corporate Operations
- Complaint Intake Centers
- Distribution Centers
Normally, baseline audits are performed following an FDA-483 or FDA Warning Letter, but baseline audits can be conducted proactively. A common request is for us to perform baseline audits following mergers or acquisitions.
We perform (FDA) pre-approval audits to help companies prepare for and successfully navigate FDA inspections. These audits are heavily focused on the areas FDA typically inspects during their preapproval inspection.
- Design Controls
- Risk Management
- Production and Process Controls
Clients have reported great success when they utilized QualityHub’s pre-approval audits as part of their commercial launch preparations.
Companies often request a verification audit that looks at corrective actions taken in response to a previous audit, to an FDA-483, or FDA warning letter. The purpose of these audits is to verify that actions taken are adequately established and implemented with appropriate documented objective evidence. These audits involve sampling and reviewing documents and records that represent the recently implemented corrective and preventive actions to determine their effectiveness.
On occasion, the FDA will require a company to hire an independent third-party expert to perform a comprehensive quality system audit of its quality system and submit the certification audit report to the FDA. These audits traditionally are performed before, during, and after remediation of quality systems.
They may be related to:
- Recidivist Warning Letters
- Corporate Warning Letters
- Consent Decrees
We are uniquely experienced in the certification process and can leverage this experience to assure the successful mitigation of enforcement actions.
Prior to experiencing a real FDA inspection, our clients often request a mock FDA inspection. While these audits typically follow the FDA approach, they also include “hats-off” sessions that allow interactive coaching and training to help personnel interact more effectively and comfortably with regulators. QualityHub has successfully prepared numerous companies for FDA visits by helping identify compliance gaps, so they can be effectively closed before the inspection.
We provide the same (or similar) QSIT audit that FDA might perform at your medical device facility. These are quality system audits that follow the FDA’s Quality System Inspection Technique (QSIT) approach.
These audits cover the four major subsystems:
- Management Controls
- Design Controls
- Production and Process Controls
- As well as other related subsystems
These audits are often performed as mock FDA inspections to provide employees with practice in effectively presenting their quality system and related documents and records to demonstrate compliance with 21 CFR 820.
Medical device, pharmaceutical and biologics companies have an obligation to audit their own quality systems and those of their suppliers. We can provide support for both internal and supplier audits, covering applicable FDA and global regulatory requirements for all or part of the quality management system.
We can also provide technical assessments of specific sites or suppliers based on product concerns, complaints, or other known quality issues. QualityHub can help lessen the product and compliance risks associated with outsourced manufacturing and supplied materials.
We especially understand the need for careful communication with suppliers in the context of an audit, as the outcome may impact the manufacturer-supplier business relationship. We have developed trust and confidence with many major regulated manufactures that routinely rely on us to meet their auditing needs.
QualityHub’s independent due diligence audits can protect our client's business while helping to plan and budget effectively for potential mergers and acquisitions (M&A).
In these instances, we perform a comprehensive quality system audit of all or selected facilities and/or product lines for compliance to FDA and/or ISO requirements. The outcomes of these audits help our clients make appropriate risk-based decisions and understand the potential need for post-acquisition investment into compliance and quality improvements.
Gap assessments are typically less formal than a typical audit with more open communication and interaction between the client and our assessors. The intent of a gap assessment is to develop a very comprehensive and detailed list of potential quality concerns to drive a quality improvement plan or corrective action plan in a specific area or process.
These may follow an audit or inspection that identified a specific quality system process as having deficiencies. Gap assessments may also be technical in nature; for example, executing a detailed review of a product-specific risk management file, design history file, masterbatch record, etc.
As opposed to a typical audit, these types of assessments provide an opportunity for coaching, sharing best practices, and making recommendations for improvement.