Q
QualityCore Product
Plan and run internal audits and self-inspections inside the quality system, so the audit and everything that came out of it stay connected.
What we are working through:
  • An audit schedule covering the year, with scope and auditor for each one
  • Findings recorded against the audit that produced them, with classification
  • A direct link from a finding to the CAPA it raised, so the full chain from observation to closure is one thread
Why this matters: self-inspection is a required part of a GMP quality system and inspectors ask to see the programme, the findings and what each finding turned into. Where the audit itself lives outside the system, a CAPA can only say that somebody raised it, and the reason it exists has to be explained from memory.