Document Control / eDMS
Controls SOP creation, review, approval, effective date, obsolescence, version history, training linkage, controlled printing, PDF preview and workflow approval. A typical document code can follow VK-GMP-QA-SOP-001 with Author to Reviewer to QA Approver routing.
Training Management
Maintains personnel records, job responsibilities, training matrix, SOP learning records, examination records, qualification status and completion rate. Personnel without required SOP training cannot perform the relevant GMP task.
Product Master Data
Maintains product code, brand name, generic name, dosage form, strength, batch size, formula, manufacturing process, specification, QC test items, packaging, shelf life, storage condition and lifecycle status.
Material & Supplier Management
Covers supplier status, API, excipient and packaging material categories, material batch numbers, COA upload, QC sampling, QA release, expiry alerts and batch traceability. Materials not released by QA cannot be used in production.
Warehouse Management
Covers receipt, quarantine, approved area, rejected area, returned goods, retained samples, temperature and humidity records, FEFO / FIFO, inventory alerts, expiry alerts, status labels, issuing and return records.
Production / eBMR
Connects production order, line clearance, weighing, granulation, drying, sizing, blending, compression, coating, packaging, yield, production review, QC submission and QA submission in one electronic batch record.
QC Laboratory / LIMS
Supports QC test requests, sample receipt, sample numbering, test assignment, analyst entry, second-person review, automatic Pass / Fail, chromatogram attachments, OOS / OOT triggers and COA generation.
QA Review & Batch Release
QA reviews production record completeness, QC results, open deviations, material release, equipment calibration and personnel training status before final electronic signature, batch release certificate and COA generation.
Deviation / CAPA / Change Control
Deviation, CAPA and change control form a closed loop with automatic numbering, severity assessment, root cause analysis, risk assessment, owner, due date, evidence, effectiveness check and QA closure.
Equipment, Validation & Stability
Maintains equipment master list, IQ/OQ/PQ, calibration and maintenance plans, cleaning records, use logs, validation master plan, process validation, cleaning validation, CSV and stability studies.
Regulatory Dossier Center
Centralizes GMP packages, Site Master File, organization charts, personnel qualifications, facility layout, equipment list, product data, SOP index, validation files, training records, deviation/CAPA summary and inspector view.
Audit Trail & System Administration
Records user, role, action, module, record ID, old value, new value, reason, date and time, IP address and e-signature status for critical operations. Ordinary users cannot delete or modify the audit trail.
