Practical guides on GxP compliance, SOC 2, 21 CFR Part 11, data infrastructure, and FDA audit readiness — written by engineers who live in these environments.
The five IT decisions that come back to haunt biotech founders at Series A due diligence — personal accounts, missing access controls, unvalidated storage, no backups, and the costly habit of waiting until later.
Shared logins, unvalidated systems, modifiable audit trails — the warning signs inspectors find most often, and how to catch them first.
EDR, enforced MFA, privileged access — the controls that protect large pharma from ransomware, and how to implement them at a startup budget.
Vendor "compliance-eligible" ≠ you're compliant. What validation, data residency, and shared responsibility really mean when you move regulated workloads to Azure, AWS, or GCP.
A plain-English breakdown of FDA's electronic records rule — scope, who it applies to, and the three core requirements every regulated company needs to meet.
GLP, GCP, GMP each have distinct IT requirements. This guide covers the four non-negotiables that cut across all of them.
Enterprise pharma and hospital systems increasingly require SOC 2 before signing. The full timeline from scoping to audit-ready.
Most life sciences companies run their ELN and LIMS as islands. The integration patterns that unlock real-time traceability and audit-ready data flows.
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