Services / SVC-02
Data Governance & Compliance
Compliance bolted on at the end is expensive and fragile. Compliance designed in from day one is mostly free. We build data practices and system architectures that are audit-ready by construction, with particular depth in regulated life-sciences environments.
What we do
SOC-2 readiness
Gap assessment, control design, and evidence practices that get you through Type I and keep you sane through Type II.
FDA 21 CFR Part 11
Electronic records and signatures done correctly: system assessments, validation strategy, and cloud architectures that satisfy Part 11 without freezing your stack in time.
CSA validation
Computer Software Assurance approaches that focus validation effort where the risk actually is — replacing thousand-page protocols with defensible, right-sized evidence.
ISO & quality systems
ISO 13485-aligned quality processes and QMS modernization, integrating regulatory, quality, and IT frameworks instead of letting them fight.
Data governance
Ownership, lineage, retention, and access — governance frameworks sized for your organization, not copied from a Fortune 500 binder.
Audit preparation
Mock audits, evidence organization, and remediation plans so the real audit is a formality, not an emergency.
Proof, not promises
Case study: Verin — audit-ready AI for life sciences →