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Inspections & Audits

RoseTECH Consulting provides specialized expertise to help you meet your GLP auditing and inspection needs.

Protocol Review – GLP protocols and amendments are reviewed for consistency and compliance with GLP regulations and internal Standard Operating Procedures.
In-Study Inspections – In-study inspections are required by the GLP regulations to be conducted at intervals adequate to assure the integrity of the study. RoseTECH can perform in-study inspections of critical phases.
Data & Report Audits – Study files are audited for completeness, reconstructibility, and proper recordkeeping and documentation practices, as well as to assure the study was conducted in adherence with the study protocol, amendments, and governing methods and standard operating procedures. Study reports are reviewed to assure the report accurately reflects the raw data and study file.

GLP Test Facility Inspections – RoseTECH can perform GLP inspections of your facility. An extensive report will summarize the areas inspected and findings, as well as recommendations for meeting compliance.
Subcontractor/CRO Audits & Inspections – Inspections of subcontractor facilities, including contract research organizations, can be conducted to qualify a facility prior to study placement or as ongoing periodic inspections to monitor compliance. Audits of completed or ongoing studies conducted at the contracted site can also be conducted.
GLP Start-up Facility Inspections – If your organization is in the preliminary stage of setting up your facility for GLP compliance, we can perform a GLP start-up facility inspection to determine where you are and what “gaps” in compliance may exist. An extensive report is written detailing the current status, findings of non-compliance, and recommendations. We will then work with you to determine an action plan for implementation of a GLP quality system.

RoseTECH has experience in conducting third-party independent audits & inspections for FDA-mandated or Sponsor-driven requests for the evaluation of study integrity/ reconstructibility.

RoseTECH can provide interim QA services to organizations during periods of heavy workload, tight deadlines or an interruption in QA staffing. We can provide QA services to start-up GLP facilities before full-time internal staff is hired or to established facilities when in-house resources are limited or at full capacity.