Artifacts: Deviation & CAPA

Documented plan developed collaboratively by Contract Giver and Contract Acceptor in response to business CAPAs resulting from audits or health authority inspections. Specifies corrective and preventive actions with owners and implementation timelines aligned with Contract Giver's documented deadlin

A GxP deviation record documenting an IT issue that impacts product quality, patient safety, regulatory compliance, or data integrity, including root cause analysis and remediation actions.

Formal report documenting an unplanned occurrence or deviation from GxP requirements, including root cause analysis and corrective actions. Must be provided within 30 calendar days upon deviation initiation for significant or major deviations.

A formal request submitted to Quality Assurance when CAPA plan deadlines cannot be met. Must be submitted before the original due date expires. Each deviation extension is limited to 30 calendar days and action plan extensions are capped at two, after which the deviation becomes overdue and escalate

A documented action plan defining specific, measurable, time-bound corrective actions to address the root cause of a deviation and preventive actions to mitigate future risks. For Medium and High risk deviations, the plan requires formal Quality Assurance approval before implementation can begin. Mu

Analysis documenting the identified root cause of a deviation. For Medium/High risk deviations this is a formal RCA using structured methodologies (Fishbone/Ishikawa, Fault Tree Analysis, 5 Whys) conducted with SMEs and QA. For Low risk deviations it is a non-formal cause/effect statement. Human err