linkedin

Turn Compliance from a Validation Burden into Always-On Infrastructure

Pharmaceutical enterprises operate in a zero-tolerance regulatory environment. FDA inspections, GxP controls, and data integrity expectations demand more than perimeter security. Cross Identity delivers cybersecurity as infrastructure—where identity governs access, privilege, signatures, and audit trails continuously, across R&D, manufacturing, clinical trials, and the supply chain.

The Pharma Reality

Identity is the New Regulatory Perimeter

Compliance Pressure Never Stops

FDA 21 CFR Part 11, GxP, ALCOA+, and global health authority expectations require provable control over who accessed what, when, and why—across years, not quarters.

High-Value Intellectual Property at Risk

Drug discovery data, formulations, clinical results, and batch records are among the most valuable digital assets in the world—yet access often sprawls across teams, partners, and legacy systems.

Complex Human + Machine Environments

Researchers, operators, QA teams, contractors, CROs, lab instruments, and automated systems all interact with regulated data—making identity governance exponentially harder.

Audit Readiness Fatigue

Most pharma organizations still assemble inspection evidence manually—screenshots, SOPs, log exports—under intense regulatory timelines.

What Changes with Infrastructure-First Identity Security

One Identity Control Plane Across the Pharma Lifecycle

Compliance by Design

Identity controls are embedded into regulated workflows—electronic signatures, access approvals, and audit trails are enforced automatically, not procedurally.

Validated, Zero-Trust Access

Access is continuously verified based on role, risk, and context—across labs, manufacturing floors, and cloud platforms—without breaking validated states.

Privilege Without Production Risk

Privileged access to manufacturing systems and infrastructure is time-bound, approved, and recorded—eliminating permanent admin risk while preserving uptime.

Continuous Inspection Readiness

Audit evidence is generated in real time from live identity activity—always attributable, immutable, and regulator-ready.

Built for Global Pharma Regulations

Cross Identity operationalizes identity controls aligned to:

  • FDA 21 CFR Part 11 – Electronic records & signatures
  • GxP (GMP, GLP, GCP) – Controlled access to regulated systems
  • ALCOA+ principles – Attributable, legible, contemporaneous records
  • Global privacy frameworks – Patient and clinical data protection

Compliance becomes an outcome of infrastructure—not an ongoing exception-handling exercise.

Where Pharma Organizations See Immediate Impact

Research & Development (R&D)

Protect molecular data and trial results with granular, role-based access while enabling secure collaboration with CROs and partners.

Clinical Trials

Ensure patient data confidentiality, controlled investigator access, and globally consistent identity governance across trial locations.

Manufacturing & Quality

Enforce electronic signatures, segregation of duties, and privileged access controls—without slowing down batch release or shop-floor operations.

Supply Chain & Third Parties

Secure vendor, contractor, and partner access with lifecycle-based identity controls that revoke access automatically when roles or contracts change.

IT & Infrastructure Teams

Replace standing admin access with just-in-time privilege and session visibility—meeting audit expectations without operational friction.

Don’t Wait for a Show-Cause Notice.

See how your current access controls map against the 2025 RBI Mandates.

One Platform. Every Archetype

The RBI applies different pressures based on how you handle money. nimbleNOVA is the only IGA platform tailored for every fintech model:

  • Payments & Wallets (PAs/PPIs) • The Headache: Separation of Duties (SoD). The RBI mandates that code-writers cannot be fund-movers.

    • The nimbleNOVA Fix: Real-time prevention of conflicting access rights across your entire production stack.
  • Digital Lending (NBFCs) • The Headache: PII Protection. Proving that sensitive borrower data is accessed strictly on a "need-to-know" basis.

    • The nimbleNOVA Fix: Logs every "Who, When, and Why" of customer data access for an ironclad audit trail.
  • WealthTech & Broking • The Headache: Privileged Access. Controlling "God-mode" access to core investment engines.

    • The nimbleNOVA Fix: Implements "Just-in-Time" access for admins, ensuring no permanent "keys to the kingdom."
  • B2B SaaS & Enablers • The Headache: Third-Party Risk. Your banking partners are now required by the RBI to audit you.

    • The nimbleNOVA Fix: Generates "Bank-Ready" audit reports in one click to satisfy your partners' compliance teams.
  • Emerging Tech (AI/Web3) • The Headache: Rapid Scaling. Manual access mapping cannot keep up with cloud-native innovation.

    • The nimbleNOVA Fix: "Zero-Touch" discovery that auto-maps identities as fast as you deploy code.

Ready to Modernize Identity Security in Pharma?

Let’s discuss how converged identity infrastructure can:

  • Reduce audit preparation from months to minutes
  • Protect IP without slowing research or production
  • Eliminate shared accounts and privilege creep
  • Maintain validated states while modernizing security