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The US Food and Drug Administration (FDA) requires the implementation of a quality system. We focus our value-added quality consulting and auditing services on your organizational needs and ensure that you have a comprehensive Quality System in place. Our Auditors will visit your location, assess what is currently in place and make recommendations to complete, if necessary a comprehensive Quality System Program.
Through this audit we will determine your current level of compliance with FDA regulations. The gap analysis can be conducted at any time on the quality system to identify deficient areas.
QST provides internal auditing services which allow for an independent review of your full quality system. We can also conduct process audits in which we focus on specific areas of the quality system where you suspect non-compliance occurs or has occurred, or focus on areas where conflicts of interest make it necessary to have an outside, independent audit desirable.
As part of your full or partial audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper internal processes or the implementation of Quality Software Programs. We can conduct supplier or Software Vendor audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with applicable standards and regulations.
We can conduct a gap or internal audit in anticipation of an FDA inspection or even assist during an actual FDA inspection. QST can assist you in identifying any problem areas of your quality system prior to an FDA inspection. This type of FDA audit is similar to a gap audit, but we focus on any areas that may be reviewed more intently by an FDA Investigator.
We can also perform an audit that would mimic an FDA inspection to help the facility prepare for an actual FDA inspection. These types of audits can be done without the knowledge of the entire organization or provided as independent assessment of readiness without company personnel being aware. The FDA mock audits are performed in the manner of a Quality System Inspection Technique (QSIT) inspection to prepare an organization for an actual FDA inspection.
Our Auditors will audit your computer system documentation against regulatory and industry standards. Auditors will determine the adequacy of the documentation, assess what is currently in place and make recommendations to supplement, if needed in the form of a Gap Analysis Plan or Remediation.
