ComplyRx Regulatory Compliance Software for Pharmaceutical MSMEs
A platform that identifies the regulatory obligations applicable to each manufacturing site and manages them through tasks, evidence, alerts and inspection readiness tools.
Solution Overview
ComplyRx identifies the regulatory obligations applicable to each pharmaceutical manufacturing site and manages them through assigned tasks, supporting evidence, alerts and inspection readiness tools. The obligation register is generated from the profile of the site, including its units, dosage forms, licences and export markets.
A rules engine selects applicable obligations from a library of 129 covering revised Schedule M, CDSCO licensing, labour, environment, export, corporate and tax requirements. Each obligation records the act and rule, the authority, the frequency, the risk level and the penalty, and is scheduled as a recurring task with an owner and an audit record.
| Obligation | Authority | Owner | Status |
|---|---|---|---|
| Drug manufacturing licence retention | State FDA | Quality Head | Due soon |
| Consent to operate renewal | Pollution Control Board | EHS Lead | Overdue |
| Provident fund monthly return | EPFO | HR Manager | Verified |
| Export registration renewal | DGFT | Regulatory | Assigned |
Compliance Challenges Addressed
MSMEs operate about 8,500 of India's 10,500 pharmaceutical manufacturing units1. The transition period for smaller manufacturers under revised Schedule M was set to end on 31 December 20252, and CDSCO reported about 860 regulatory actions from more than 960 risk-based inspections by July 20263.
Obligations Spread Across Regulators
A single plant answers to CDSCO and the State Drugs Controller, labour and provident fund authorities, the State Pollution Control Board, DGFT, the Ministry of Corporate Affairs and GST authorities, each with its own forms, frequencies and penalties.
Inspection Exposure
Expired licences, missing evidence or open corrective actions are often discovered by the inspector during the visit.
Fragmented Records
Spreadsheets, paper registers and shared folders leave no single view of what applies, what is due and who completed it.
How ComplyRx Works
Each obligation moves from identification to verified closure, with a record of the owner, the evidence and the date of every action.
Complete Site Profile
Units, dosage forms, licences and markets
Map Obligations
Rules applied to 129 items
Review Dashboard
Score and critical items
Assign Tasks
Owners, due dates and recurrence
Upload Evidence
Versioned, with expiry date
Verify and Close
Owner or Quality Head
Rescore and Recur
Next due date created
Daily Alerts
Due soon, overdue and expiry
Export Audit Trail
PDF for inspectors
Update Library
Reviewed by administrators
Inspection Readiness
Before a CDSCO, State FDA or WHO-GMP inspection, the Quality Head opens the inspection readiness module. A readiness score is computed from live data across five domains, and the document check lists missing or expired evidence for each checklist item. The score is rechecked after remediation.
Document Expiry Alerts
- 90 days before expiry
- 30 days before expiry
- 7 days before expiry
Readiness Score Caps for Severe Risk
Readiness Domains
- Documentation
- Equipment
- CAPA and deviations
- Pharmacovigilance
- Licences
Platform Modules
Core Compliance
- Company profile
- Obligation library
- Applicability engine
- Compliance score
- Tasks and workflow
- Document vault
- Alerts and digest
- Audit trail
- Team and roles
Inspection Readiness and Quality
- Readiness score
- 95-item checklist
- Mock inspection
- Gap-analysis report
- SOP lifecycle
- CAPA
- Change control
- Deviation and OOS
- Training records
- Product review
Export, Vendors and Environment
- Export registrations
- Export NOC and DGFT
- Vendor qualification
- Pollution control consents
- Waste, fire and MSDS
Reporting and Updates
- MD and board reports
- Ageing and trend reports
- Regulatory change log
- Webhooks
Key Capabilities
Obligation Management
- Act, rule, authority, frequency, risk level and penalty recorded for each obligation
- Tasks with subtasks, comments and recurrence
- Role-controlled verification and closure
Evidence and Audit
- Versioned document vault
- Expiry alerts at 90, 30 and 7 days
- Audit trail protected against edits at database level
- PDF export for inspectors
Score and Reporting
- Weighted 0–100 compliance score with daily snapshots
- Monthly MD report and board summary
- Ageing report and 12-month trend
- CSV and XLSX export
Inspection Readiness
- Readiness score across five domains
- 95-item checklist mapped to regulatory clauses
- Mock inspection with compliant or gap recording
- Printable gap-analysis report
Quality Management
- SOP lifecycle and training records
- CAPA and change control
- Deviation and out-of-specification log
- Product quality review
Export, Vendors and EHS
- Country registrations, export NOC and DGFT calendar
- WHO-GMP readiness view and CoA template builder
- Vendor master and approved vendor list
- Pollution control consents, effluent, waste, fire safety and MSDS records
Comparison with Typical Approaches
| Capability | Typical Approach | ComplyRx |
|---|---|---|
| Obligation register | Spreadsheet maintained by a consultant, or none | Generated from the site profile with legal references and penalties |
| Regulatory breadth | Quality tools cover GMP only; compliance calendars cover legal filings only | Schedule M and CDSCO with labour, environment, export, corporate and tax in one register |
| Inspection readiness | Manual checklist review before a visit | Score from live data, checklist, mock inspection and gap report |
| Quality system | Paper SOPs and CAPA registers, or an enterprise QMS | SOP, CAPA, change control, deviation, training and product review in the same platform |
| Evidence and audit | Files in shared folders | Versioned evidence with expiry alerts and a protected audit trail |
Intended Users
Quality Head
Assigns and verifies tasks, reviews evidence and prepares the site for inspection.
Managing Director
Reviews the compliance score, trends, overdue items and monthly reports.
Regulatory, Production, QC, HR and EHS Staff
Complete assigned tasks and upload evidence.
External Consultant
Supports the site through a dedicated consultant role on the platform.
Team Member and Viewer Roles
Provide controlled participation and read-only access.
Department Manager
Manages tasks and evidence for a department.
Security and Record Integrity
| Control | Implementation |
|---|---|
| Company data isolation | Each record carries a company identifier taken from the authenticated session; cross-company lookups return not-found |
| Access control | Six roles: Owner, Quality Head, Department Manager, Team Member, Viewer and External Consultant |
| Audit trail | Audit events written on every change; a database trigger rejects updates or deletions of audit records |
| File handling | Short-expiry links for upload and download, a file type allow-list, a 20 MB limit and version history |
| Authentication | Hashed passwords, e-mail verification, and one-time reset and invitation tokens |
Scope and Current Coverage
Frequently Asked Questions
Which manufacturers is ComplyRx designed for?
ComplyRx is designed for Indian pharmaceutical MSMEs, including units preparing for inspection under revised Schedule M and WHO-GMP certified, export-oriented units.
How does ComplyRx determine which obligations apply to a site?
The company profile records entity type, units and states, dosage forms, licences and export markets. A rules engine applies this profile to the library of 129 obligations and computes recurring due dates.
Does ComplyRx guarantee a successful inspection?
No. ComplyRx supports compliance management and inspection preparation. Inspection outcomes depend on the facility and its practices, and the product does not replace professional regulatory advice.
Can an external consultant work on the platform?
Yes. A dedicated External Consultant role is available. A multi-client consultant console is planned.
Can the audit trail be edited?
No. A database trigger rejects updates or deletions of audit records, and the trail can be exported to PDF for inspectors.
How does ComplyRx relate to Ayush QMS?
ComplyRx manages the broad register of obligations for pharmaceutical MSMEs. Ayush QMS is the dedicated quality system for AYUSH manufacturers, with batch records and validation-level record controls.
Request a ComplyRx Demonstration
Aevum Digital can demonstrate the obligation register, compliance score and mock inspection for a sample site. The ComplyRx brochure is available on request.
References
- KNN India, one-year extension considered for small pharma firms ahead of Schedule M rollout, December 2025. Source.
- Business Standard, small pharma companies get one-year breather to implement Schedule M, February 2025. Source.
- Medical Dialogues, 860 high-risk pharma units face regulatory action under quality drive, July 2026. Source.
ComplyRx supports compliance management. It does not guarantee inspection outcomes and does not replace professional regulatory advice. Manufacturers should confirm their individual position with the licensing authority. Regulatory information on this page was last reviewed on 1 November 2026 and is provided for general information.