Process authoring
Pods
A pod composes approved agents into an ordered, gated, path-resolved process traceable to one or more SOPs. No process models, no separately authored workflows.
CAPA pod
CAPA · owner Priya N. · SOP-DEV-002 v1.0
Effectivev1.0 effective · v1.0a draft
Corrective and preventive action: problem statement, root cause, action plan and effectiveness check.
Steps
3
Paths
2
Agents
2
Effort
6 h
gates 2a · 2n · 1r · 1e 1 SOP newer in vault
Release pod — change control + CSA
Change control · owner Priya N. · SOP-CC-003 v4.2 · SOP-VAL-001 v6.0 · SOP-QA-011 v2.1 · SOP-SUP-004 v1.0
Effectivev2.1 effective · v2.2 draft
Composes change control, computer software assurance and pre-deployment verification into one governed pod, resolved by GAMP category and risk class.
Steps
13
Paths
4
Agents
6
Effort
70 h
gates 9a · 4n · 10r · 3e 17 readiness issues 1 unapproved agent 2 SOP newer in vault
Periodic audit pod
Periodic review · owner Dr. Elena V. · SOP-VAL-001 v6.0
Effectivev1.3 effective · v1.4 draft
Annual periodic review of validated systems: scope, evidence sampling and the continued-validation statement.
Steps
3
Paths
2
Agents
2
Effort
6 h
gates 2a · 2n · 1r · 1e 1 SOP newer in vault