GxP Auditing and Consulting Services
GxP auditing acts as a key quality assurance tool, fostering confidence in the industry's ability to consistently deliver safe and effective products. To assist our clients in their GxP compliance requirements, Clinical Pathways offers comprehensive auditing and consulting services tailored to our client’s unique needs. Our team of experienced, detail-oriented professionals are available to audit onsite, remote, or hybrid across the GxP.
Clinical Pathways also provides support and coordination of responses for internal or external audits, mock inspections, and regulatory inspections.
Our scope of GxP auditing includes:
Trial Master Files (TMFs)
Regulatory Submissions (INDs, NDAs, CSRs, IBs, etc.)
Vendor or Contract Service Provider Audits (routine or for cause)
Vendor Qualification/Requalification Support (audits, risk assessments, questionnaires, etc.)
GCP and Clinical Investigator Site Audits
GCLP / Central Labs
GLP Facilities
Computer Systems/eSystems Audits and Support
21 CFR Part 11 and EU Annex 11 compliance
Computer System Validation (validation plans, User Acceptance Testing (UAT), system specifications, requirement specifications
Software Contract Service Provider/Vendor
Data Integrity
Cybersecurity
Data Privacy
GMP/PAI Audits and Support
Quality Management System (QMS) development
Establishment of quality agreements and manuals
Suppliers, Packagers
QA review of master/executed batch records, specifications, test methods, validation and stability, protocols and reports