The IntuitionLabs Trust Center

Q: How do I report a security concern or responsible disclosure?

Email info@intuitionlabs.ai with details of the concern. We acknowledge every report within one business day. For coordinated vulnerability disclosure we follow ISO/IEC 29147 guidelines, maintain communication with the reporter, credit researchers who request it, and commit to timelines for remediation, retesting, and public advisory where applicable.

Transparency about how we earn and keep the trust of regulated pharmaceutical, biotech, and life sciences clients — our compliance posture, AI governance, partnerships, and independent controls.

Book a Meeting

Four Foundations of Trust

Verified Partnerships

IntuitionLabs is an official Veeva Vault CRM X-Pages Certified Partner. Our engineers are trained on the platform and deliver compliance-ready analytics and extensions on Vault CRM.

Regulated-Industry Compliance

21 CFR Part 11, EU Annex 11, HIPAA, GDPR, and GxP best practice are designed into every deliverable. We produce the IQ/OQ/PQ and audit evidence your quality team needs from day one — not bolted on after delivery.

Responsible AI Governance

Every AI-enabled solution ships with a model card, intended use statement, data lineage, validation protocol, and human-in-the-loop provisions, aligned with the NIST AI RMF and emerging FDA AI/ML guidance.

Enterprise-Grade Infrastructure

Client workloads run on AWS, Google Cloud, Vercel, and Cloudflare — inheriting ISO/IEC 27001, HIPAA-eligible, and FedRAMP-authorized controls at the platform layer.

Trust is a regulated concern

In pharmaceutical and biotech, a vendor becomes part of your validated system boundary. Regulators ask who touched your data, who wrote your code, and whose controls you relied on. This Trust Center gives your quality, security, privacy, and procurement teams a single reference point for how IntuitionLabs operates across compliance, AI governance, and infrastructure.

Pharmaceutical regulatory compliance review

Built for the regulated buyer

Every engagement leads with validation, not velocity. Before the first line of code we scope intended use, regulatory classification, GxP impact, data classification, and audit evidence requirements. The result is software that passes the audit the first time — which, in practice, is faster and cheaper than rushing to ship and rebuilding in remediation.

Engineered for audit readiness

Every engagement ends with an evidence package your quality, security, and privacy teams can hand straight to an auditor. That means traceability matrices, validation protocols, test records, model cards, data processing records, and inherited-control matrices — not a pile of emails and spreadsheets reconstructed after the fact. Audit-ready is the default delivery mode, not a premium add-on.

Audit-ready evidence documentation review

Frameworks We Align To

The standards and guidances that shape how we build, validate, and document systems for regulated clients.

21 CFR Part 11

FDA requirements for electronic records and electronic signatures — audit trails, access control, authority checks, record integrity, and signed-record workflows.

EU Annex 11

European counterpart to Part 11 for computerised systems in GxP environments, including validation, risk management, change control, and electronic signatures.

GAMP 5 (2nd Edition)

ISPE's risk-based approach to computerised system validation, including the updated lifecycle guidance for agile development and continuous delivery.

ICH Q9 / Q10

Quality risk management and pharmaceutical quality system principles that inform how we prioritise validation effort and lifecycle controls.

HIPAA / HITECH

US health information privacy and security controls for any engagement handling protected health information, backed by a Business Associate Agreement.

GDPR / CCPA / CPRA

Privacy frameworks covering lawful basis, data subject rights, cross-border transfer, and state-level consumer privacy for EU and California residents.

NIST AI RMF

Voluntary framework for managing risks of AI systems — governance, mapping, measurement, and management across the AI lifecycle.

ISO/IEC 42001

Management system standard for artificial intelligence, used to benchmark our AI governance processes and client deliverables.

ISO/IEC 27001

Information security management system standard, inherited from our infrastructure providers and used to benchmark internal controls.

Our Pillars of Trust

Every engagement is held against the same four pillars. They appear in our Statement of Work, in our validation deliverables, and in the evidence we hand over at project close. They exist so that no client ever has to wonder whether trust was designed in or sprinkled on top.

These pillars are not aspirational — they are measurable. Every pillar maps to concrete artifacts, controls, and acceptance criteria that live inside the engagement itself.

Compliance by Design

Regulatory controls written into the system from day one — never bolted on after functional delivery.

Evidence on Demand

Every claim we make is backed by an artifact your auditor can request: validation protocols, test records, model cards, DPIAs.

Reversible Autonomy

AI features default to suggest-and-confirm workflows, with full override and a logged human-in-the-loop decision for any GxP-impacting action.

Computer System Validation

Every system we deliver into a GxP environment ships with a validation package scaled to its risk classification. Category 5 custom configurations and Category 4 configured products receive full IQ/OQ/PQ protocols, traceability matrices, and deviation logs. Category 3 non-configured products receive supplier assessment and vendor audit records. We follow GAMP 5 (2nd Edition) lifecycle principles and adapt deliverables to modern agile and continuous-delivery workflows without losing audit trail integrity.

Validation lifecycle documentation review

AI Governance artifacts

For every AI-enabled feature we ship a governance packet: an intended use statement, data sheet describing training and reference data lineage, a model card, a validation protocol with acceptance criteria, a bias and fairness assessment where relevant, and explicit human-in-the-loop provisions for GxP-impacting decisions. This packet is written in language your quality unit can sign and your auditor can read — not a research paper, not marketing copy.

AI governance review for pharmaceutical solution

Privacy by design

We apply data minimisation, purpose limitation, storage limitation, and lawful basis analysis to every engagement. Where an engagement touches EU personal data we perform a Transfer Impact Assessment aligned with the EDPB guidance that followed Schrems II. Where an engagement touches PHI we execute a BAA and scope technical and administrative safeguards to the specific workflow. Privacy reviews happen before the kickoff meeting — not after a data incident.

Privacy and data protection compliance assessment

Partner and Platform Credentials

The partner certifications and platform controls that underpin every IntuitionLabs engagement.

Veeva Vault CRM X-Pages Partner

Officially certified on the Vault CRM X-Pages development framework. Confirm in the public Veeva partner directory.

Review partnership

AWS infrastructure

Primary hosting and compute inherit ISO/IEC 27001, HIPAA-eligible, and FedRAMP-authorized infrastructure controls from AWS.

AWS compliance programs

Google Cloud Platform controls

Selected AI and data workloads run on Google Cloud, inheriting ISO/IEC 27001 and HIPAA BAA coverage where applicable.

GCP compliance

Cloudflare Enterprise edge

Our public properties ride Cloudflare's enterprise edge and DDoS-mitigation infrastructure, inheriting ISO/IEC 27001 coverage.

Cloudflare Trust Hub

Vercel deployment platform

Next.js production deployments run on Vercel's HIPAA-eligible platform, with immutable build artefacts and signed deployments.

Vercel security

Sub-processor transparency

A current list of sub-processors with location, purpose, and data-category is maintained and updated at least quarterly. Clients receive notice of material changes.

Request current list

Vendor and sub-processor management

We keep the sub-processor footprint small and documented. Every sub-processor is assessed against security, privacy, data residency, and support-quality criteria before onboarding and re-assessed annually. Clients can request the current list under NDA and are entitled to material-change notice before a new sub-processor begins processing their data. When a sub-processor is retired we document the off-boarding path and the data destruction certificate chain.

Vendor and sub-processor risk management review

Business continuity and disaster recovery

Client-facing systems run in a multi-region, multi-availability-zone configuration with automated failover for the web tier and documented RPO and RTO targets for each workload. Backups are encrypted, geographically separated, and tested on a defined cadence. We run a disaster recovery tabletop exercise at least annually and document lessons learned. A continuity plan exists at the company level for extended loss-of-facility and key-person scenarios.

Disaster recovery and business continuity planning

Incident response and disclosure

An incident response runbook defines severity classification, escalation chain, client notification timelines, and communication owners. For confirmed security incidents involving client data we commit to client notification within the contractually agreed window and follow up with a root cause analysis and corrective action plan. Responsible-disclosure reports from security researchers are acknowledged within one business day and handled under an ISO/IEC 29147-aligned process.

How We Protect Client Data

The operational commitments every IntuitionLabs engagement runs against.

Purpose-Limited Data Use

Client data is used only for the purposes defined in the Statement of Work and applicable data processing terms. Client data is never used to train models for other customers, and is never sold, rented, or shared.

Contracted From Day One

Engineering work begins after a countersigned MSA and SOW are in place, with a Business Associate Agreement and Data Processing Addendum where applicable. Authority for every activity is traceable from the first commit.

Validation-Aligned Delivery

GxP-impacting changes ship with the validation evidence regulators expect. Where timelines compress, scope is phased so that every production release is backed by its IQ/OQ/PQ package.

Audit-Ready Artefacts

Every deliverable ends with an evidence set — traceability matrix, test records, validation summary, data lineage — ready to hand to your quality unit or external auditor without reconstruction.

Sub-Processor Discipline

The sub-processor footprint is kept small, documented, and reviewed. Clients receive material-change notice and can request the current list under NDA during procurement review.

Named Accountability

Every engagement has a named engineering owner, a named security owner, and a named partner-level escalation point. Responsibility for every control is clear before work begins.

Frequently Asked Questions

Our Trust Center documents how we earn and maintain the trust of pharmaceutical, biotech, and life sciences clients. It covers our partnership credentials, regulatory compliance approach (FDA 21 CFR Part 11, EU Annex 11, HIPAA, GDPR, GxP), responsible AI governance, computer system validation practices, vendor risk management, data handling and retention policies, business continuity planning, and the independent assessments that back up our claims. Every page we build and every line of code we deliver is designed to withstand a regulated-industry audit.

Yes. IntuitionLabs is an official Veeva Vault CRM X-Pages Certified Partner. Our developers are trained on the Vault CRM X-Pages platform and deliver custom analytics, dashboards, and extensions for life sciences teams on Veeva Vault CRM.

All solutions we deliver are designed from the ground up to comply with 21 CFR Part 11 controls for electronic records and electronic signatures. That means validated audit trails, controlled access, system use checks, authority checks, record protection, and signed-record integrity. We produce IQ/OQ/PQ validation documentation, deviation reports, traceability matrices, and training records that integrate directly into your quality management system. See our 21 CFR Part 11 software development service for full scope.

We believe AI deployed in GxP and PV environments must be explainable, auditable, version-controlled, human-reviewed, and bias-tested. We follow the NIST AI Risk Management Framework, track emerging guidance from the FDA's AI/ML program, and align our client engagements with the voluntary ISO/IEC 42001 AI management system standard. Every AI-enabled solution we deliver includes a governance artifact: intended use statement, data lineage, model card, validation protocol, and human-in-the-loop provisions.

Client data is segregated by tenant, encrypted in transit and at rest, and retained only for the period specified in the Master Services Agreement. We minimize data collection — we request the least amount of PHI/PII needed to complete a deliverable. For HIPAA-covered engagements we execute a Business Associate Agreement before touching any data. Sub-processors are vetted, documented, and kept to the minimum number necessary. On engagement close we return or securely destroy client data according to a defined schedule and provide a certificate of destruction on request.

Yes. IntuitionLabs maintains professional liability (errors and omissions), commercial general liability, and cyber liability coverage appropriate for life sciences consulting engagements. Certificates of insurance and coverage limits can be shared under NDA as part of client vendor onboarding and procurement review.

Our production systems are hosted on providers (AWS, Google Cloud, Vercel, Cloudflare) that hold ISO/IEC 27001 certifications and equivalent attestations whose scope we inherit. Our internal control narrative and inherited-control matrix are available under NDA to qualified prospects and clients.

Email [email protected] with details of the concern. We acknowledge every report within one business day. For coordinated vulnerability disclosure we follow ISO/IEC 29147 guidelines, maintain communication with the reporter, credit researchers who request it, and commit to timelines for remediation, retesting, and public advisory where applicable.

Ready to see our Trust Center in action?

Book a 30-minute call with our team. We can walk your security, quality, or procurement reviewers through our control narrative, inherited-control matrix, and validation templates directly.

Book a Meeting