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Compliance Consulting Services
Based on our broad experience, we
assist our clients in the full range of GxP compliance issues, especially
in those areas involving computerized systems. These projects have
been both short and long term and have involved many types of laboratory,
manufacturing, clinical, and developmental processes and computerized
systems of many platforms. We have extensive experience in
evaluating software (both in-house developed and vendor-supplied) for
compliance with FDA regulations and expectations. Many of the
systems we have assessed and/or have been involved with as validation
consultants have involved enterprise-wide systems spanning multiple
facilities.
Our compliance consulting
experience includes management consulting, audits of management
practices, developmental activities for computerized systems, review of
validation efforts and documentation, review and development of internal
SOPs, the conduct of failure investigations, pre-submission reviews, and
audits of all areas and phases of manufacturing and research and
development.
Through our management consulting
efforts, we have helped our clients’ senior management to fully
understand their compliance responsibilities as well as the potential
magnitude of their corresponding corporate and personal exposure to
regulatory enforcement. EduQuest personnel
have extensive experience in the full range of compliance and enforcement
activities, including both administrative actions and criminal
prosecutions.
We
also assist our clients in preparing for FDA inspections and in managing
and responding to inspectional observations (Form 483 citations) and
other enforcement actions, such as Warning Letters. Our experience
in both technical and compliance issues gives us the ability to
objectively assess the communications problems that are often at the core
of enforcement activities. In many cases, we have been able to
substantially improve our clients’ understanding of the underlying
compliance issues and the clarity and effectiveness of their related
communications with FDA. We also have extensive experience in
identifying, designing, coordinating, and implementing corrective actions
and both the short and long term resolution of regulatory compliance
problems.
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