Ayush QMS Schedule T Quality Management Software for AYUSH Manufacturers
A quality management system for Indian Ayurveda, Siddha and Unani drug manufacturers that digitises GMP records from raw-herb receipt through batch release and export documentation.
Solution Overview
Ayush QMS is a quality management system built for Indian Ayurveda, Siddha and Unani drug manufacturers. It replaces the paper ledgers, batch manufacturing records and spreadsheets commonly used to meet Schedule T of the Drugs Rules, the good manufacturing practice (GMP) standard for these medicines.
The data model reflects Ayurvedic manufacturing directly. Batch records are specific to each of 12 kalpana dosage forms, Rasa Shastra purification (Shodhana) and Bhasma preparation are recorded with electronic signatures, and quality control specifications are derived from seeded Ayurvedic Pharmacopoeia (API) monographs and Ayurvedic Formulary (AFI) references.
| Stage | Parameter | Result |
|---|---|---|
| Line clearance | Area and equipment | Verified |
| Kwatha preparation | Volume and temperature | Recorded |
| Sneha Paka | Stage end point | In progress |
| Yield reconciliation | Variance against limit | Pending |
| Approved lot | Result |
|---|---|
| Herb lot HL-310 | QC approved |
| Oil lot OL-118 | QC approved |
Quality Challenges Addressed
India had 8,604 licensed AYUSH drug manufacturing units in April 2024, of which 7,347 make Ayurvedic medicines1. The Drugs (Eleventh Amendment) Rules, 2026 revised Schedule T and extended the requirements for manufacturing, quality and documentation, with existing manufacturers given until 31 July 2029 to align2,3. Overseas buyers and regulators also expect documented, auditable records.
Records That Fail Data Integrity Tests
Paper batch records completed after the event breach the ALCOA+ principle that entries are contemporaneous and attributable. Corrections, missing signatures and back-filled yields are common findings.
Material and Batch Control by Hand
Quarantine labels can fall off, specifications are copied from pharmacopoeia volumes into spreadsheets, and a recall requires manual reconstruction of which herb lots went into which batches.
Generic Software Does Not Fit
General pharmaceutical quality software typically has no model of processes such as Sneha Paka or Asava fermentation, and no Rasa Shastra controls or API monograph content.
How Ayush QMS Works
The sequence below follows a batch from supplier qualification to release and distribution. Each step writes to the audit trail, and status gates prevent a step from starting until the previous step is complete.
Qualify Supplier
GACP audit and staged pipeline
Receive Herbs
Lot quarantined; CITES check
Test Raw Material
Monograph specifications and HPTLC
Release Lot
Quarantine to approved
PlannedCreate Batch
Formula and kalpana template
Allocate Lots
Approved lots only, traced
Execute Batch Record
Kalpana stages and Shodhana
Reconcile Yield
Variance raises a deviation
Submit for QC
Blocked by open deviations
Finished-Product QC
OOS quarantines the batch
QA Disposition
E-signature and four-eyes check
CoA and Distribution
Forward trace for recalls
- Approved suppliers deliver
- Approved lots allocated
- Open yield deviations block QC
- QA disposition with e-signature
Platform Modules
Compliance Foundation
- Tenant isolation
- Verifiable audit trail
- E-signatures
- Role-based access
- Workflow engine
- Retention controls
AYUSH Knowledge and Batch Records
- API monographs
- AFI formulary
- Pratinidhi dravya
- Harvest calendar
- Formula master
- Kalpana stage records
- Rasa Shastra
- Batch disposition
Quality Control and Quality System
- QC tests and OOS
- CoA generation
- Method validation
- Stability studies
- Deviations and CAPA
- Training
- Internal audits
- Equipment
- Complaints and recalls
- Label compliance
Supply Chain, Regulatory and Export
- Supplier pipeline
- GACP audit scoring
- CITES lot guard
- Lot traceability
- Schedule T mapping
- Ayush Mark checklist
- Export dossiers
- Regulatory feed
AYUSH Knowledge Base
Reference content is held in the platform so that acceptance criteria are derived from monographs in place of being copied into spreadsheets. The figures below describe the current reference data set.
Key Capabilities
Electronic Batch Records
- Versioned formula master and templates for 12 kalpana types
- Line clearance and in-process parameters
- Sneha Paka, Avaleha Paka, fermentation, sieving, compression and distillation stages
- Yield reconciliation with automatic deviation
Rasa Shastra
- Shodhana records with electronic signature
- Sign-off by an authorised Vaidya or Hakim
- Bhasma preparation logs and puta cycles
- Bhasma quality tests
Quality Control
- Test requests with server-side OOS detection
- Phase I and II OOS investigations
- Certificates of analysis and method validation
- Stability studies, retain samples and analyst competency gate
Quality System
- Deviations and CAPA
- Training records and internal audits
- Equipment calibration and qualification
- Complaints, adverse events and recalls
- Label compliance, including a Drugs and Magic Remedies Act claim scanner
Supply Chain
- Supplier qualification pipeline
- WHO-GACP audit scoring
- CITES lot guard
- Forward and backward traceability from herb lot to distribution
Regulatory and Export
- 125 Schedule T and WHO-GMP clauses with gap analysis
- Mock inspection and Site Master File
- Ayush Mark checklist
- CoPP, EU THMPD, UK THR, US DSHEA and AYUSHEXCIL documents
Deviation and CAPA Management
Sources of Deviation
- Manual entry
- Yield variance
- Schedule T gap
- Supplier audit finding
- Process-parameter excursion
Rule-Based Severity
- Omitted Shodhana step
- Bhasma test failure
- Heavy-metal OOS result
- These events are always classed as critical, with a seven-day due date
Investigation and Closure
- 5-Why and fishbone analysis
- CAPA with owners and due dates
- Effectiveness verification
- Closure with electronic signatures
Comparison with Typical Approaches
| Capability | Typical Approach | Ayush QMS |
|---|---|---|
| Batch records | Printed records of up to 50 pages; generic templates for tablets and liquids | Templates and stage records for 12 kalpana types |
| Rasa Shastra | Notebook records of purification and incineration | Shodhana records signed by an authorised Vaidya or Hakim, with Bhasma logs and tests |
| QC specifications | Copied by hand from pharmacopoeia volumes | Derived from seeded monographs and marker compounds |
| Schedule T | Consultant checklists before an inspection | Clauses mapped to records, with gap analysis and mock inspection |
| Audit trail and signatures | Wet signatures and spreadsheets | Append-only audit ledger with cryptographic verification and e-signatures |
| Export documents | Dossiers assembled manually for each market | CoPP, EU THMPD, UK THR, US DSHEA and AYUSHEXCIL documents from batch data |
Intended Users
Managing Director or Plant Head
Reviews inspection readiness and overall quality status.
Head of Quality Assurance
Manages Schedule T and WHO-GMP inspections, deviations and batch disposition.
QC Head and Analysts
Run test requests, OOS investigations and certificates of analysis.
Production Chemists and Operators
Complete batch records on the shop floor.
Vaidya or Hakim
Signs off classical formulations and Shodhana steps.
Regulatory Affairs
Prepares export dossiers and the Site Master File.
Data Integrity and Security
| Control | Implementation |
|---|---|
| Audit trail | GMP writes recorded in an append-only ledger with actor, role and before and after values, with Merkle-proof verification |
| Electronic signatures | Designed to the pattern of US FDA 21 CFR Part 11, with re-authentication, stated meaning, four-eyes check and a linked audit transaction |
| Tenant isolation | Database row-level security enforced on every tenant-scoped table |
| Segregation of duties | Role-based access with AYUSH-specific roles; system administrators have no access to GMP records |
| Data integrity | ALCOA+ mapping, server-side timestamps, soft deletion only and retention enforcement |
Scope and Current Coverage
Frequently Asked Questions
Which manufacturers is Ayush QMS designed for?
Ayush QMS is designed for Ayurveda, Siddha and Unani drug manufacturers subject to Schedule T, with an initial focus on export-oriented units and units preparing for the revised Schedule T.
Does Ayush QMS support the revised Schedule T notified in 2026?
The current mapping covers Schedule T and WHO-GMP clauses. A dedicated conformance pack for the 2026 revision is planned ahead of the 31 July 2029 date for existing manufacturers.
Are the electronic signatures compliant with 21 CFR Part 11?
The signatures are designed to the pattern of 21 CFR Part 11, including re-authentication, stated meaning and a four-eyes check. Compliance for a given use depends on the manufacturer's own validation, and validation documentation is planned.
Does the system support classical Rasa Shastra processes?
Yes. Shodhana records with electronic signature, Bhasma preparation logs, puta cycles and Bhasma quality tests are included.
Which export documents can be prepared?
CoPP, EU THMPD, UK THR, US DSHEA and AYUSHEXCIL documents can be generated from batch data.
How does Ayush QMS relate to ComplyRx?
Ayush QMS is the quality system for AYUSH manufacturers. ComplyRx manages wider obligations such as labour, environment, export and corporate requirements, and an Ayush QMS customer can use ComplyRx for those obligations.
Request a Ayush QMS Demonstration
Aevum Digital can demonstrate a kalpana batch record, a Shodhana sign-off and a Schedule T gap analysis using sample data.
References
- Ministry of Ayush, Ayush in India 2024. Source.
- Lexplosion, Drugs (Eleventh Amendment) Rules, 2026 for ASU drugs. Source.
- Corpseed, AYUSH Drugs (Eleventh Amendment) Rules, 2026 compliance requirements. Source.
Ayush QMS supports quality management. It does not guarantee inspection outcomes and does not replace professional regulatory advice. Regulatory information on this page was last reviewed on 1 November 2026 and is provided for general information.