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Home / Product companies / VI · Healthtech and life sciences / Pharma and life sciences / Pharma manufacturing and quality software
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Pharma manufacturing and quality software Making the drug, a million packs at a time, to strict quality rules Back to the skin cream from Market Segments 25.1 to 25.4. It has passed its trials, and the regulator has approved it. Now it must be made, a million tubes at a time, in a plant that might well be in Hyderabad or near Ahmedabad.

A medicine is made in a plant that must prove, batch by batch, that every step was done exactly as approved:

  • every machine has been tested and shown to work as it should, which is called validation
  • every cleaning of the equipment is recorded
  • every mistake or departure from the plan, called a deviation, is investigated
  • every pack can be traced all the way to the patient

India supplies medicines to much of the world. It makes a large share of the world's generic medicines, the cheaper copies made once a medicine's patent runs out, and of its vaccines. The software for making medicines and checking their quality is a field in which Indian companies lead. The buyers are drug makers. This is a small Market Segment: four companies, and two more that are covered mainly in other Market Segments.

Every company named here has posted software engineering jobs in India. Famous companies that don't actively hire software engineers in India are left out.

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  • What this section holds
What this section holds

Back to the skin cream's plant from the start of this Market Segment. Before its mixers and filling machines can make a single approved tube, each one must be validated, and every step recorded.

Proving every batch: each machine is validated (ValGenesis), each step on the factory floor is directed and recorded (Leucine), deviations are investigated in quality management (BPR Hub), and every pack gets its own number so it can be traced to the patient (TraceLink).Proving every batch: each machine is validated (ValGenesis), each step on the factory floor is directed and recorded (Leucine), deviations are investigated in quality management (BPR Hub), and every pack gets its own number so it can be traced to the patient (TraceLink). ValGenesiswith engineers in Chennai and Hyderabad, has the most job postings in this Market Segment. It was founded by Indian entrepreneurs. It sells validation software that most large drug makers use to prove that their equipment, processes and cleaning meet the regulators' rules. It replaces binders of paper with a digital record. Leucinewith engineers in Bengaluru, sells a manufacturing execution system, the software that directs and records each step on the factory floor. It also sells quality management and cleaning validation, built for Indian plants. BPR Hubsells quality and compliance management. Redica Systemsgathers the findings of regulators' inspections, so drug makers can see what inspectors are looking for.

Two companies covered mainly in other Market Segments bring the trace and the standard:

TraceLinkwith engineers in Pune, is here for serialisation: giving every pack of medicine its own number, so it can be tracked through the supply chain. (More on it in Market Segment 30.4, Shipment tracking and supply chain visibility platforms, in Industry Vertical 30, Supply chain and logistics.) US Pharmacopeiawith engineers in Hyderabad, is here for the standards against which medicines are tested. (More on it in Market Segment 44.3, Tech-for-good nonprofits, in Industry Vertical 44, Govtech and nonprofits.) The plant that releases its own batches.

Most of a batch's paperwork proves that nothing went wrong. Now plants can keep validated digital records, with sensors and AI models reviewing them. So regulators are starting to let drug makers release a batch on the evidence of the data, rather than a person's review of paper. India's plants, many still on paper, have the most to gain.

Today a person reviews a batch's paperwork before it is released; with validated digital records reviewed by sensors and AI models, regulators are starting to let a batch be released on the evidence of the data.Today a person reviews a batch's paperwork before it is released; with validated digital records reviewed by sensors and AI models, regulators are starting to let a batch be released on the evidence of the data.

Some well-known names are not here. Sun Pharma, Dr. Reddy's Laboratories, Cipla, Lupin and India's other drug makers are not covered in this Market Segment, and neither is MasterControl. The engineering centres of the global drug companies are covered elsewhere. (More on them in the GCC collection.)

So the skin cream from the start of this Market Segment reaches its tube only after software has done its work. It has validated every machine, recorded every step, and given every pack its own number.

Who they hire

Who these companies hire, and for what, is on What pharma and life sciences companies hire for.

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