Challenge
Validation documentation produced manually for every change
Our response
Risk-based CSV approach with automated test evidence capture and traceability matrices generated from the pipeline.
Pharmaceutical & Life Sciences practice
Validated systems for regulated science.
Life sciences technology carries a validation burden most sectors never face. We deliver GxP-aligned systems with computer system validation, 21 CFR Part 11 controls, electronic batch records and serialisation — documented to withstand inspection.
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Less time locating documents
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Less manual document handling
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Audit-traceable records
Sector challenges
What pharmaceutical & life sciences clients bring us
Left column is the problem as it is usually described to us. Right column is what we actually build in response.
Challenge
Batch records on paper, slowing release and inviting error
Our response
Electronic batch records with in-process checks, deviation capture and review-by-exception release.
Challenge
Serialisation and track-and-trace obligations across markets
Our response
Serialisation platform with aggregation, market-specific reporting and partner data exchange.
Challenge
Research and trial data fragmented across systems and sites
Our response
Governed research data platform with lineage, controlled access and reproducible analysis environments.
Compliance
Frameworks we design against
Regulatory obligations common in pharmaceutical & life sciences. We treat these as architectural inputs from the first design session.
- 21 CFR Part 11
- GxP (GMP / GCP / GLP)
- EU Annex 11
- GAMP 5
- DSCSA & EU FMD serialisation
- HIPAA
Platforms deployed in this sector
Infilabs Document Management
Controlled documents, findable in seconds.
Infilabs Workflow Automation
Design, run and measure business processes without code.
Infilabs Inventory & Warehouse
Know what you have, where it is, and what it costs.
Infilabs Learning Management System
Compliance training and skills development that gets completed.
Services most used by this sector
Enterprise Software Development
Custom platforms, CRM, ERP, HRMS and workflow systems engineered for the way your business actually operates.
Data Engineering & Analytics
Lakehouse platforms, ETL/ELT pipelines and governed analytics that turn scattered systems into one trusted layer.
Cyber Security
Offensive testing, SOC and SIEM, identity, cloud security and compliance programmes for ISO, GDPR and HIPAA.
AI & Machine Learning
Production-grade generative AI, applied ML and autonomous agents — governed, evaluated and observable.
Pharmaceutical & Life Sciences enquiry
Let us talk about your pharmaceutical & life sciences programme
You will speak with someone who has delivered in this sector before — not a generalist reading a capability deck.