Pharmaceutical Quality Management
GxP quality systems, deviations/CAPA, change control, batch release.
Pharmaceutical Quality Management (BC-1560) is a level-1 business capability in the Pharmaceuticals & Life Sciences model. The catalog holds 5 API surface(s) from 2 provider(s) that can perform some part of it. Reach is the vendor surface that lands on this capability — it is not a claim about what any particular organisation has deployed.
Sub-capabilities
GMP Compliance Management BC-1560.10
GMP compliance framework, regulatory inspection readiness.
GxP Quality Control Management BC-1560.20
QC labs, analytical testing, stability testing.
GxP Quality Assurance Management BC-1560.30
QA review, batch record review, oversight.
Deviation & CAPA Management BC-1560.40
Deviation handling, CAPA, effectiveness checks.
GxP Change Control Management BC-1560.50
GxP change control, impact assessment.
Pharma Supplier Quality Management BC-1560.60
Supplier qualification, audits, quality agreements.
Batch Release Management BC-1560.70
Qualified Person release, batch certification.
Annual Product Quality Review Management BC-1560.80
APQR/APR, product quality trend analysis.
Providers that reach this capability
Ordered by rating band. Reach means a provider publishes an API surface that can perform some part of this capability — it is not a claim that any particular organisation has deployed it.