KairosCRO Services LLC · Austin, TexasLeadershipInstitutional partnershipsContactTeam Vault
CLINICAL RESEARCH. CONNECTED.
Pharmacovigilance & Drug Safety/Quality & inspection readiness

SAFETY SERVICES / 06

PV Quality, Audits & Inspection Readiness

Assess safety processes, strengthen quality controls and prepare teams to explain their work with evidence.

Discuss this service
Illustrative research and medical expertise
Specialist expertise. Clear accountability.
What this service covers
  • PV quality systems
  • PV compliance assessments
  • Inspection readiness
  • Audit preparation and support
  • CAPA development and follow-up
  • Vendor qualification and oversight
Potential deliverables
  • Risk-based gap assessment
  • Inspection preparation and evidence plan
  • CAPA and vendor oversight action plans
What to bring to the discussion
  • Quality system and SOP inventory
  • Audit or inspection history and open findings
  • Vendor scope and evidence availability

Qualified specialists, delivery arrangements and responsibilities are agreed before contracting.

WHAT WE CAN SUPPORT

Expertise for your scope.

  • PV quality systems
  • PV compliance assessments
  • Inspection readiness
  • Audit preparation and support
  • CAPA development and follow-up
  • Vendor qualification and oversight

Potential deliverables

  • Risk-based gap assessment
  • Inspection preparation and evidence plan
  • CAPA and vendor oversight action plans

Start with your context

  • Quality system and SOP inventory
  • Audit or inspection history and open findings
  • Vendor scope and evidence availability