Good Laboratory Practices

Good Clinical Practices

Good Manufacturing Practices

JAF goes beyond the ‘check the box’ step of conducting audits or assessments by partnering with our clients to develop and implement remediation strategies (if required) that meet both the business and regulatory requirements.

In addition to being a required part of working in a regulated environment, our hands-on approach to compliance assessments, audits, and training work to ensure the dynamic compliance requirements of your research, nonclinical, clinical, or manufacturing organization is achieved.

JAF is experienced in providing ad-hoc QA resource solutions and conducting audits of all types including but not limited to facility, process, bioanalytical, full-service CRO, study-specific data and reports, archives, niche services, and more.

Clinical Trial Audits

Our team of experts conduct study-specific GCP audits of protocols, investigator sites, trial master files, pharmacovigilance, databases, and report for a wide variety of clinical trials. These audits will be customized to your specific compliance needs and relevance for the stage of product development. Our team has conducted audits within the United States, Canada, Europe, United Kingdom, Asia, and Pacific Rim.

JAF works with Sponsors and trial sites to assess and implement quality measure designed to enhance and maintain quality throughout your clinical trial.

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Laboratory Audits

JAF is also a leader in discovery or translational research (non-GLP), nonclinical (GLP), clinical (GCP), or commercial product QC support (GMP), and ensures that data is credible and complies with all regulatory requirements.

Our team of experts has worked with laboratories across the globe to provide a comprehensive range of services for all types of laboratories. In addition to audits to identify compliance needs, we offer expert advice and guidance on laboratory-related quality issues, establishment, and implementation of quality management systems (QMS), preparation of laboratory policies and SOPs including QC analytical test methods, development and implementation of routine monitoring practices, development and delivery of training curricula, and development and implementation of continuous improvement initiatives.

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Systems & REDCap Validation

Computerized systems are used across all regulatory disciplines (GCP, GLP, GMP) to support regulated activities and range from bespoke (or niche) systems to commercial-off-the-shelf (COTS).

Our team of experts provides tailored comprehensive Computer Systems Validation (CSV) auditing services in all stages of the computerized system life cycle. The objective is to assess good systems implementation practices, and IT system management practices, and to verify that the computerized systems are validated according to predicate rule regulatory requirements and 21 CFR Part 11.

CSV can be the sole focus of an audit or can be combined with any of our auditing services.

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