Solution stories
Pharma Formulation Unit: Faster Batch Review, Clean Traceability
Recipes, electronic batch steps, equipment data and genealogy working together for faster review.
Trikaan Research & Engineering4 min read
KEY TAKEAWAYS
- Batch review time was dominated by checking transcription.
- Capturing data directly from balances and equipment improved integrity.
- Review by exception needed trusted system controls.
- Traceability became a query, not a search.
A formulation unit making tablets and capsules for domestic and export markets wanted faster batch release and stronger data integrity.
This scenario shows how the products combined. It is not regulatory advice.
The situation
Paper batch records were reviewed line by line. Weighings were transcribed from balance printouts. Equipment parameters were recorded by hand at intervals. Release was slow and audit preparation consumed weeks.
What they had already tried
- Additional QA reviewers.
- Scanned PDFs of batch records for retrieval.
- Spreadsheets tracking deviations.
How we diagnosed the real problem
We mapped a batch from dispensing to packing and timed each review step.
- Most review time went into checking transcribed values.
- Deviations were logged separately from batch records.
- Equipment data was recorded only at fixed intervals.
The solution, product by product
No single product solved this. The value came from the products working on the same data.
| Product | Role in this solution |
|---|---|
| ASTR Production | Master recipes with versions and approvals, electronic batch steps, limits and deviations |
| Anvaya | Material receipt, quarantine and release, dispensing, lots, dispatch |
| Machine Digital Twin | Equipment parameters captured from PLCs and instruments |
| ASTR Reporting | Batch status, deviations and release cycle time |
How it rolled out
- Master record harmonisation.
- Balance and instrument integration.
- Pilot product with defined exception rules.
- Validation activities per the quality system.
What changed
Reviewers focused on exceptions rather than every line once the controls were trusted.
- Batch review time reduced by [X]%.
- Transcription errors eliminated for integrated equipment.
- Full lot genealogy available on demand.
What we would tell a similar company
- Fix master records first.
- Integrate balances early.
- Agree exception rules with QA.
- Plan validation as part of the project.
Frequently asked questions
Does this replace our QMS?
No — it supports batch execution and records within your quality system.
Is validation required?
Follow your quality system and regulatory guidance.
Is this a real customer?
It is an illustrative composite.
- #pharma manufacturing software case study
- #batch record digitisation case
- #pharma traceability
- #formulation plant digital
- #pharma equipment monitoring
Trikaan Research & Engineering
Trikaan
Written by the researchers and engineers who build Anvaya, ASTR and Seed Track, with input from Trikaan's delivery and engineering teams.
