GLP Services

• SOP development, writing, editing and/or review; SOP gap analysis and report
   
• SOP, Protocol and Final Report Quality Control
  • QC for clarity of prose, spelling, grammar, finding common mistakes such as “data is” vs. “data are”
     
• Raw data Quality Control
  • Calculations review, missing data point, initials/dates
     
• Quality Assurance audits for GLP compliance
  • Check Protocol and Final Report for all required elements, formatting requirements, Complete citations for SOPs and reference test methods
  • Full protocol, data and report audit with a written report on the audit findings
  • Study in-process, raw data, and final report audits
  • Facility audits and new-laboratory qualification audits
     
• Datasheet preparation; Checklist preparation
   
• Pre-inspection independent audits - EPA and FDA nonclinical studies
  • Record-keeping & documentation
  • Equipment logbooks, calibration schedules, maintenance records
  • SOP and protocol management
  • In-process inspections
  • Personnel records
  • QA records and SOPs, Master Schedule review
  • Archives

Includes a prompt written report of audit findings categorized into high-level GLP compliance problems and less critical compliance issues.  Reports also include a summary of the processes that are noteworthy for being in full compliance, ensuring excellent data quality and integrity.  Inspections aren’t always a bad thing!