Industry
Pharma and Life Sciences
Validated quality, batch and lab systems for pharma plants and life science labs. In pharma every record about a batch may be read by an inspector years later, so systems need audit trails, electronic signatures and documented validation. Indian plants supply domestic markets under Schedule M and export under USFDA and EU GMP, often from the same site. Software fits where batch records, deviations, lab data and document control still move on paper or unvalidated spreadsheets.
- Formulation manufacturers
- API and bulk drug makers
- Contract manufacturers (CDMOs)
- Analytical and clinical research labs
- Medical device makers
- Pharma distributors and C&F agents
The pressure points
What slows pharma and life sciences teams down
- Paper batch records
- Batch manufacturing records are printed, filled by hand and reviewed page by page before release. Errors and late entries become inspection findings.
- Systems never properly validated
- Spreadsheets and small tools run GxP processes without a validation pack, user access control or audit trail.
- Deviations and CAPAs drag on
- Investigations stall in email, root causes repeat across batches, and effectiveness checks are forgotten.
- Data integrity under scrutiny
- Inspectors check ALCOA+ principles: who entered what, when, and whether it could have been changed. Shared logins and hybrid systems fail that test.
Systems this sector runs on
The software we build and connect
Each of these can be built new, extended from what you already use, or connected to your existing ERP and accounting.
- Manufacturing Execution SystemMESElectronic batch records with recipe enforcement, weighing and dispensing checks, in-process controls and review by exception.
- Document Management and WorkflowDocument managementSOPs, specifications and master documents with controlled versions, periodic review, training linkage and Part 11 signatures.
- Governance, Risk and Compliance ManagementGRC and complianceQMS workflows: deviations, CAPA, change control, market complaints and audit observations with due dates and trending.
- Supply Chain and Warehouse ManagementSupply chain and WMSQuarantine, released and rejected status, FEFO picking, batch genealogy and cold chain records.
- Learning Management SystemLMSRole based GMP training with read-and-understood records tied to SOP revisions.
- Dealer and Distributor Management SystemDealer and distributorField force and stockist orders, scheme management and secondary sales visibility for domestic formulations.
Built for this sector
Systems specific to pharma and life sciences
The work that generic software does not cover, and where most of the value sits.
- Electronic batch manufacturing records
- Step by step execution on the shop floor with equipment status, line clearance, yield calculations and QA review before release.
- LIMS integration
- Sample login, test results and certificate of analysis flowing between LIMS, chromatography data systems and batch release.
- Serialisation and track and trace
- Unique codes on primary and secondary packs, aggregation to shippers, and reporting for export market requirements.
- Validation documentation
- URS, risk assessment, IQ, OQ and PQ protocols and traceability matrix produced alongside the build, following GAMP 5.
Where AI helps
AI use cases with a clear return
Deviation and CAPA drafting
Drafts the deviation description, impact assessment and probable causes from batch data and past investigations, for QA to review and sign.
Investigations start from a complete draft
SOP and investigation search
Answers questions across SOPs, past deviations and audit responses, citing document and version.
Similar past cases are found before a repeat CAPA is raised
Artwork and label checking
Compares printed artwork proofs against approved text, flagging differences in strength, batch fields and regulatory statements.
Label errors caught before printing
Batch record review support
Highlights out of range values, late entries and missing signatures in executed batch records for the reviewer.
Faster review with exceptions in front of QA
Demand forecasting for slow movers
Forecasts demand for low volume SKUs from secondary sales and seasonality to plan campaign batches.
Less near-expiry stock in the channel
What your team would see
- Batches awaiting QA release
- 23
- Open deviations
- 41
- CAPAs past due date
- 6
- Right first time batches
- 94%
Average days to close a deviation
Deviations by category
- Documentation34
- Equipment22
- Process18
- Materials15
- Environment11
A sample of the kind of dashboard we build for this sector. Figures are illustrative.
Connects with
- SAP and Oracle ERP
- LIMS
- Chromatography data systems
- Weighing balances and scales
- Building management and environment monitoring
- Serialisation line controllers
- Field force and stockist systems
Rules we design for
- Schedule M
- CDSCO requirements
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5
- Drugs and Cosmetics Act 1940
Typical stack
Read more
Work and writing for this sector
Before you start
Pharma and Life Sciences: common questions
Do you deliver validated systems?
We build to a validation plan and supply the documents: URS, functional specs, risk assessment, test protocols and traceability. Your QA owns the validation and approves each stage.
Can AI be used in a GxP process?
Yes, as an assistant. It drafts and highlights, a qualified person reviews and signs, and the system records both the AI output and the human decision.
We have an old LIMS. Do we replace it?
Not necessarily. We often integrate with the existing LIMS and CDS, and replace only where the system cannot meet data integrity requirements.
Talk to us
Working in pharma and life sciences?
Tell us which process hurts most. Someone who knows the sector will reply with two or three options and rough hours.
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