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Infovion

Healthcare

Software development for pharma manufacturers, distributors and pharmacies

From batch records and QC to stock by batch and expiry, QR codes on packs and reports for management, we build the systems your plant, warehouse and pharmacies run on, and document them so QA can validate them.

What software do pharmaceutical companies need?

A pharmaceutical company typically needs software for production and batch records, quality control and assurance (sampling, certificates of analysis, deviations, CAPA and change control), inventory by batch and expiry, QR-code traceability, distribution and sales, and management reports. Under India's revised Schedule M, computerised systems used for GMP must be validated and protected against data tampering, and companies exporting to the US must meet 21 CFR Part 11 for electronic records and signatures. Infovion Technologies builds and integrates these systems for manufacturers, distributors and pharmacy chains, with validation documents for the client's QA team.

Updated 5 November 2026 by Infovion Technologies, Pune.

Scope

What we deliver

Production and batch records

Electronic batch records, process steps, yields and reconciliation, with audit trails and electronic signatures.

Quality control and assurance

Sampling, test results, certificates of analysis, deviations, CAPA and change control.

Inventory and warehouse

Stock by batch and expiry (FEFO), quarantine and release, and cold-chain temperature logs.

QR codes and traceability

QR codes for Schedule H2 brands and other required categories, with lookups for distributors and patients.

Distribution and field sales

Orders, schemes, stockist and retailer billing, medical representative reporting.

Pharmacy chains

Billing, Schedule H and H1 registers, branch stock, transfers and expiry returns.

Revised Schedule M and computerised systems

The revised Schedule M (Good Manufacturing Practices) requires GMP-related computerised systems to be validated, with controls that prevent data tampering and loss and keep records traceable. Large manufacturers had to comply first; the extension for MSME units ran to 31 December 2025. We build systems with audit trails, access control and the documents your QA team needs to validate them.

Exporting to the US: 21 CFR Part 11

  • Secure, time-stamped audit trails for every record change
  • Unique user accounts and electronic signatures linked to their records
  • Validated systems, with documented requirements and tests
  • Records that can be copied and retained for inspection

QR codes on medicines

Since 1 August 2023, the 300 drug brands listed in Schedule H2 must carry a barcode or QR code on the label, and the requirement has since been widened to more categories of medicines. We build the code generation, label data and lookup systems; check CDSCO's current notifications for the categories that apply to you.

Validation support

  • User requirements, functional and design specifications
  • Traceability from requirements to tests
  • Support for installation, operational and performance qualification (IQ, OQ, PQ)
  • Documentation aligned with GAMP 5; your QA team approves and signs

Sources: CDSCO: FAQs on QR codes for Schedule H2 drugs · CDSCO · US eCFR: 21 CFR Part 11, electronic records and signatures

Deliverables

  • Process study of plant, QC, warehouse or pharmacy
  • Requirements and design documents for validation
  • Software with audit trails and electronic signatures
  • Test scripts and traceability matrix
  • Data migration and training
  • Annual maintenance with change control

Typical clients

  • Pharma manufacturers, including MSME units
  • Contract manufacturers
  • Distributors and C&F agents
  • Pharmacy chains
  • Nutraceutical and ayurvedic manufacturers

Technologies

React, Node.js, NestJS, PostgreSQL, React Native, Barcode and QR printing, Hosting in India

Cost and timeline

Cost of pharma software development in India

Indicative budget ranges for the Indian market in 2026, provided for planning. Each project receives its own fixed-price proposal after an initial consultation.

Typical budget ranges for Pharma Software Development in India
Project typeTypical budget
Single module (QC, inventory or QR)₹3 – 10 lakh
Multi-module system for a plant or distributor₹10 – 30 lakh
Validation documentsQuoted with the system

Timeline. Modules in eight to fourteen weeks, including validation documents; larger systems in phases.

Factors that affect cost

  • Modules and sites
  • Validation scope and US export requirements
  • Integration with ERP, Tally or machines
  • Number of users and branches
Request a fixed-price proposal

Process

How the project is delivered

  1. 01Week 1

    Discovery

    An initial consultation, followed by a requirements workshop for larger projects, to understand processes, users and objectives.

  2. 02Within 2 business days

    Proposal

    A written scope, milestone plan and fixed-price proposal, so cost and timeline are agreed before work begins.

  3. 031–3 weeks

    Design

    Wireframes and a clickable prototype reviewed with your team before development starts.

  4. 042-week sprints

    Development

    Fortnightly releases to a staging environment, with a review at the end of each sprint.

  5. 051–2 weeks

    Testing and launch

    Functional and security testing, user acceptance testing, data migration, training and go-live.

  6. 06Ongoing

    Support

    Thirty days of post-launch support, followed by an optional maintenance contract.

FAQ

Frequently asked questions

Does revised Schedule M require validated software?

Yes. Computerised systems used for GMP must be validated and protected against data tampering and loss, with traceability. The final extension for MSME units ran to 31 December 2025.

What is 21 CFR Part 11?

The US FDA rule for electronic records and electronic signatures. It applies to companies whose records support products sold in the US, and requires audit trails, unique logins, linked electronic signatures and validated systems.

Which medicines need QR codes in India?

The 300 brands listed in Schedule H2 since 1 August 2023, and further categories added since. Check CDSCO's current notifications.

Can you integrate with our ERP or Tally?

Yes. We connect QC, inventory and pharmacy systems to SAP, Tally or other ERPs through their APIs or data exports.

Do you provide validated software?

We build software with validation in mind and supply the documents and test evidence; your QA team performs and approves the validation, as GMP requires.

Discuss your pharma software development requirements

Share a brief description of your project. We respond within one business day with questions, an approach and a fixed-price proposal where the scope allows.