Controlled workflow lifecycles
Configure draft, review, approval, release, rejection, effective, hold, closure, and other role-authorized status transitions around operational records.
Compliance-Supporting Controls
Evidence-oriented controls for regulated manufacturing workflows
Pharma Setu ERP provides configurable workflow, record, signature, traceability, and audit-evidence capabilities that can support GMP-oriented operations and 21 CFR Part 11 readiness activities.
Electronic records and signatures
Maintain role-aware actions, signature context, timestamps, comments, attachments, and related evidence where enabled in the approved ERP configuration.
Traceability and audit evidence
Connect product, material, batch, pack, sample, test, document, equipment, transaction, and user activity records for investigation and review.
Quality and document controls
Support specifications, methods, COA, deviations, CAPA, changes, complaints, SOPs, training, controlled distribution, and acknowledgement workflows.
Software capabilities alone do not make an organization compliant or certified. Each customer remains responsible for validation, configuration, procedures, training, access administration, data governance, and compliance with the regulations applicable to its operations.
Quality-event review and closure
This representative lifecycle illustrates investigation, documented actions, effectiveness checks, authorized review, closure, and management visibility that can support evidence-oriented operating practices. Representative workflow illustration; configuration and responsibilities vary by implementation.
Controlled documents and training
This representative lifecycle illustrates authored revisions, review, approval, effective issue, controlled distribution, training, acknowledgement, and periodic review. Representative workflow illustration; configuration and responsibilities vary by implementation.