Expert industry insights
Practical articles on lab software, data and AI, written by the team that builds software for biotech companies.
CRO LIMS × Biotech
How to choose a LIMS for a biotech CRO
How to choose a LIMS for a CRO, covering sponsor data separation, study and contract workflows, sample traceability, and when a custom build is worth it.
Myroslav SyrkoCOO at CodePhusionAI × Compliance
The EU AI Act for biotech in 2026
A 2026 guide to the EU AI Act for biotech, what counts as high risk, why most research AI does not, the proposed delay, and what it means for lab software.
EU × FDA Compliance
EU Annex 11 vs 21 CFR Part 11 explained
EU Annex 11 vs 21 CFR Part 11, covering how the EU and US rules for computerised systems differ and how to build lab software that satisfies both markets.
Compliance × ELN
How to choose a 21 CFR Part 11 compliant ELN
What a 21 CFR Part 11 compliant ELN needs, including audit trails, electronic signatures, access controls, ALCOA+ data integrity, validation, and cloud ELNs.
Compliance × Lab Software
What your lab software needs for 21 CFR Part 11
Learn how 21 CFR Part 11 affects lab software architecture. Covers audit trails, electronic signatures, validation, and change control for FDA compliance.
Compliance × Patient Data
What HIPAA compliance requires from lab software
What HIPAA compliance requires from lab software, from protected health information and technical safeguards to audit trails and breach notification rules.
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