Tell us about your systems and we'll show you how one programme can satisfy ISO 27001, SOC 2 and your GxP validation obligations together.
IT governance and security compliance for regulated industries
Regulated organisations carry a dual obligation: validating the software systems that support regulated processes, and proving the IT infrastructure beneath them meets ISO 27001, SOC 2, HIPAA and GDPR requirements. As regulators increase scrutiny of IT controls, managing the two in isolation creates compliance risk and duplicated effort. Ideagen Software Validation addresses both through a single coordinated programme.
What is IT governance and security compliance?
IT governance and security compliance in regulated industries is the structured management of information security controls, policies and risk assessments to meet applicable standards and regulatory frameworks. For life sciences, healthcare and financial services, that means demonstrating compliance with ISO 27001 (information security management), SOC 2 (security and availability controls), HIPAA (US healthcare data), GDPR (EU data privacy) and sector-specific requirements such as HITECH and EHNAC.
Ideagen Software Validation builds information security management systems (ISMS) and security control frameworks that satisfy multiple standards at once and integrate with existing software validation and data integrity programmes.
Achieving and maintaining ISO 27001 and SOC 2 certification
ISO 27001 requires a comprehensive Information Security Management System (ISMS) and is widely mandatory for suppliers in regulated sectors internationally. SOC 2 is the standard expectation for US-facing B2B organisations, requiring independent attestation of security, availability, processing integrity, confidentiality and privacy controls. Many regulated organisations need both.
Ideagen Software Validation supports every stage of ISO 27001 certification and SOC 2 readiness, from gap analysis and control design through to audit preparation. Because both frameworks share common ground in risk assessment, access controls and documentation, Ideagen runs them in parallel where practical, cutting the time, cost and resource burden of achieving and maintaining each.
Security control preparation for HIPAA, HITECH and EHNAC
US healthcare organisations and their technology vendors must comply with HIPAA's Security Rule and Privacy Rule, governing electronic protected health information (ePHI), alongside HITECH, which strengthened HIPAA enforcement, and EHNAC, the Electronic Healthcare Network Accreditation Commission standard for healthcare IT. Together these require a security risk analysis, documented safeguards, breach notification procedures and evidence of ongoing compliance maintenance.
Ideagen Software Validation has taken healthcare providers and health IT vendors in the US and UK through HIPAA, HITECH and EHNAC compliance programmes: security risk assessments, aligning technology stacks and policy frameworks to certification requirements and building the governance infrastructure that sustains compliance across audit cycles rather than ahead of a single assessment.
Harmonising IT governance with GxP validation and data privacy obligations
Validated GxP systems must meet their validation requirements and the access control, audit trail, data residency and security requirements of the IT governance framework. GDPR obligations apply wherever validated workflows process personal data. And with cloud or SaaS systems, the shared-responsibility model between vendor and customer creates governance complexity that has to be addressed in both the validation strategy and the ISMS.
Ideagen Software Validation builds integrated programmes that align IT security controls, GxP validation requirements and data privacy obligations in one framework, eliminating duplication, closing the gaps that open when these workstreams run separately and providing the unified evidence base regulators increasingly expect.