Governance and Compliance

At New England Innovations, we recognize that compliance is mission-critical in the biotechnology and pharmaceutical industries. Our Governance, Security, and Compliance services are engineered to meet the rigorous standards of FDA-regulated and GxP environments while enabling innovation, speed, and scalability. We help you build and maintain a secure, compliant, and audit-ready IT ecosystem that supports your scientific mission and protects your most valuable assets, your data, your IP, and your reputation.

Our Governance and Compliance Services

☑ Regulatory Compliance & Audit Readiness

Stay aligned with global and industry-specific regulations and ensure every system is inspection-ready:

• Compliance with 21 CFR Part 11, HIPAA, GxP, ISO 27001, SOC 2, and other international frameworks
• Computer System Validation (CSV) in alignment with GAMP 5 principles, including complete documentation lifecycle support
• Data integrity controls covering ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available)
• Electronic records/signatures (ERES) compliance for FDA and EMA requirements
• SOP development, periodic review cycles, deviation management, and CAPA tracking integrated with quality systems
• Pre-audit readiness assessments and mock inspections to prepare for FDA, EMA, and other regulatory body audits

☑ Information Security & Risk Mitigation

Secure your data and defend against evolving threats:

• Proactive cybersecurity architecture with MFA, EDR, and SIEM solutions
• Role-based access controls and data encryption at rest and in transit
• Continuous threat monitoring and incident response customized for R&D environments
• Regular vulnerability assessments and penetration testing

☑ IT Governance & Change Control

Ensure transparency, accountability, and operational integrity:

• Centralized IT policy governance and change management tracking
• Enforcement of Standard Operating Procedures (SOPs)
• Configuration management and access control aligned with validated systems
• Governance dashboards for real-time system health and compliance tracking

☑ Identity & Access Management (IAM)

Control access with precision and confidence:

• Implementation of least-privilege access models
• Automated user provisioning/deprovisioning
• Integration with Azure AD, Okta, and third-party IAM systems
• Support for federated identity and conditional access policies

☑ Cloud & Hybrid Security Compliance

Extend governance and security to cloud-based and hybrid infrastructures:

• Secure deployment of regulated workloads in public, private, or hybrid cloud environments
• Cloud cost governance and data sovereignty controls
• Support for cloud-native platforms like Microsoft 365, Benchling, Veeva, and AWS
• Audit trail integration and compliance mapping for cloud-hosted applications

☑ Business Continuity & Data Resilience

Protect critical systems and ensure data availability:

• Validated backup and disaster recovery (DR) plans with defined RTO/RPO
• Business continuity strategies for lab systems like LIMS, ELN, ERP, and QMS
• End-to-end validation of backup workflows and recovery exercises
• Redundancy and high-availability planning across infrastructure tiers

☑ Vendor & Application Compliance Integration

Extend governance across your vendor and software ecosystem:

• Integration of LIMS, ELN, QMS, and other validated systems
• Secure data exchange with CROs, CDMOs, and global collaborators
• Vendor risk assessments and support for validation documentation
• Lifecycle governance of third-party scientific applications