Audit-ready from day one. Zero label escapes. No recall surprises.
For Pharma, FMCG, Ayurvedic, and packaging manufacturers operating under FSSAI Schedule 4, Ayush GMP Rules 2008, and global regulatory frameworks — we build the artwork lifecycles, documentation systems, and CAPA structures that make compliance a daily habit, not an audit-week scramble.
Artwork Lifecycle Management
Under FSSAI Schedule 4 and Ayush GMP Rules 2008, every label is a regulated document — not a design asset. A missing Ayush Mfg. Lic. number, an incorrect ingredient quantity, or a stale batch-coding template can trigger market recall or licence suspension. We've seen it happen. We've also built the systems that prevent it.
We redesign your artwork workflow from brief to press — establishing version-controlled master label repositories, cross-departmental approval gates (QC, Regulatory, Legal), and Batch Packing Record integration so every printed label is traceable to an approved source file. For Ayurvedic manufacturers, we layer in Sanskrit/Latin bilingual ingredient disclosure, Anupana instructions, and classical reference citations as built-in checklist steps, not afterthoughts.
- Master Label Repository with Version Control & Audit Trail
- FSSAI & Ayush Labelling Checklist Workflows (RDA%, Allergens, Classical Refs)
- Multi-Stakeholder Approval Gates: QC → Regulatory → Print Release
- Batch Packing Record (BPR) Integration & Prepress Vendor Governance
Regulatory Information Management
The FSSAI Action Plan our team compiled for food business operators covers 17 compliance domains — from location hygiene and building design all the way through to licensing registration. Most organizations manage these domains across scattered folders, expired certificates, and memory. That's a product recall waiting to happen. We consolidate your regulatory universe — FSSAI licence status, Ayush Manufacturing Licence renewals, Vendor COA tracking, water-testing records, and packaging certifications — into a single auditable architecture with automated renewal alerts and role-based access control.
- Centralized Dossier & Licence Register (FSSAI + Ayush)
- Automated Licence & Certificate Renewal Alerts
- Approved Vendor List (AVL) & COA Management
- Regulatory Change Monitoring & SOP Update Triggers
Documentation, Validation & Audit Readiness
The FSSAI Action Plan mandates that records be maintained for at least 5 years (Ayush GMP) or shelf life plus one year — whichever is longer. Every BMR, BPR, deviation log, calibration record, and training register must be version-controlled, signed, and instantly retrievable when an inspector walks in. We build the documentation architecture to make that happen: SOP libraries with annual re-approval workflows, Master Formula Records signed by QC Head before first commercial batch, and distribution records traceable to individual retailer invoices. For computer-controlled processes, we additionally implement electronic record and e-signature systems aligned to GMP requirements for data integrity.
- BMR / BPR Architecture & QC Sign-Off Workflows
- Immutable Audit Trails & e-Signature Readiness
- 5-Year Document Retention & Version Control Systems
- Deviation Log, Change Control & CAPA Closure Register
Risk Mitigation, CAPA & Recall Prevention
FSSAI and Ayush GMP both require that any deviation from SOPs or BMR be documented, investigated, and formally closed within 30 days with a Corrective and Preventive Action. Consumer complaints must be investigated and closed within 30 days, with serious ones escalated to the authority. And every licensed FBO must run a mock recall drill at least once per year — tracing 100% of an affected batch in under 24 hours. Most businesses only discover these gaps during an actual crisis. We build the CAPA register, deviation log, complaint severity classification system, and batch traceability infrastructure before the inspector — or the market — tests it.
- Deviation Log & 30-Day CAPA Closure System
- Consumer Complaint Register with Severity Classification
- Batch Traceability (RM → FG → Distributor) & Mock Recall Drills
- eCommerce Recall Integration & WMS/OMS Block Triggers