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.
Audit Readiness Fatigue
Most pharma organizations still assemble inspection evidence manually—screenshots, SOPs, log exports—under intense regulatory timelines.
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.
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.
Executive Overview
Pharma in a Highly Regulated, Data-Driven Environment
Identity as a Foundation for Data Integrity and Trust
The Limits of Traditional Security Approaches
Cybersecurity-as-an-Infrastructure in Pharma
Purpose and Scope of This Report
Don’t Wait for a Show-Cause Notice.
See how your current access controls map against the 2025 RBI Mandates.
Why Pharma Leaders Choose Cross Identity?
The Pharma Identity Challenge: Data Integrity, Scale, and Complexity IAM in the Global Pharma Ecosystem
- Expanding Digital Footprint Across the Pharma Value Chain Pharmaceutical organizations increasingly operate through complex digital ecosystems that span research, clinical development, manufacturing, quality, regulatory affairs, and commercialization. Core activities such as laboratory research, clinical trials, batch manufacturing, quality investigations, and regulatory submissions are executed through interconnected systems across global locations. As these digital environments expand, ensuring consistent and secure access across the entire value chain becomes significantly more challenging.
- Data Integrity as a Central Operational Concern Data integrity is a foundational requirement in pharma operations. Regulated data must be accurate, attributable, contemporaneous, and reliable throughout its lifecycle. Identity plays a critical role in enforcing these principles by ensuring that only authorized individuals can create, modify, review, or approve regulated records. Weak identity controls—such as shared accounts, excessive permissions, or poor lifecycle governance—undermine data integrity and introduce compliance and quality risk.
- Diverse and Distributed Identity Populations Pharma organizations manage a highly diverse identity population that includes scientists, clinical staff, manufacturing operators, quality teams, IT administrators, external investigators, CROs, CMOs, and vendors. In addition, automated systems and integrations generate a growing number of non-human identities. Governing access consistently across this mix of internal and external users, each with different responsibilities and regulatory implications, is a major operational challenge.
- Long System Lifecycles and Historical Accountability Many pharma systems operate over long lifecycles and support records that must be retained for years or even decades. During this time, personnel, roles, and organizational structures change frequently. Identity systems must therefore support long-term accountability, enabling organizations to demonstrate who had access to regulated systems at specific points in time. Without strong identity governance, reconstructing historical access during inspections becomes difficult and resource-intensive.
- Third-Party Collaboration and Oversight Collaboration with CROs, CMOs, laboratories, and academic institutions is essential to pharma innovation and scale. However, third-party access introduces additional complexity and risk. External users often require access to regulated systems and sensitive data, making precise scoping, monitoring, and lifecycle management essential. Inadequate oversight of third-party identities is a common source of regulatory observations and inspection findings.
- Automation and Non-Human Identity Risk Automation supports efficiency across pharma operations, from laboratory workflows to manufacturing execution and reporting. APIs and service accounts often operate with elevated privileges, yet may lack the governance applied to human users. Without proper controls, non-human identities can become high-impact risk vectors that compromise data integrity and system reliability.
- Compounding Risk Across the Ecosystem The combination of data integrity requirements, diverse identity populations, long system lifecycles, and extensive third-party collaboration creates compounding identity risk. These challenges cannot be effectively addressed through isolated or manual controls. Managing identity at this scale requires a unified, infrastructure-level approach that aligns security, quality, and regulatory objectives.
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
