GxP Systems Life-Cycle Management & Validation

GxP Excellence Without The Organization Overhead

Small and mid-sized biotechs and pharmas face a complex reality: regulatory compliance demands enterprise-grade GxP systems, but managing these validated environments requires specialized expertise that is difficult to maintain in-house. The result? Either over-engineered solutions that drain resources, or compliance shortcuts that create regulatory risks.

What is the GxP lifecycle? Simply put, it's the complete journey of your regulated systems, starting from system selection and implementation to ongoing compliance and eventual retirement. Every phase demands precise documentation and the right level of validation. It becomes even more crucial for biotechs and pharmas pursuing regulatory approvals for commercial launch, as these systems become the backbone of your regulatory success.

Narala's GxP lifecycle management services are tailored to the unique needs of your organization and right-sized based on the risks. We offer comprehensive oversight of your validated systems environment while enabling operational efficiency. We ensure every platform–be it in-house or third-party owned and managed–operates in a state of continuous compliance.

We integrate seamlessly with your existing operations, thinking, and acting like your internal IT Quality team. We understand that compliance is a journey and not a destination; it's an ongoing operational reality that needs to keep evolving. We ensure that the systems and associated policies and procedures are always in an inspection-ready state.

Our Core Capabilities

Our specialized GxP lifecycle management services transform compliance from operational burden to competitive advantage, ensuring every validated system drives your scientific mission forward.

System Selection & Implementation

Navigate the complex landscape of GxP platforms with strategic guidance on vendor selection, solution architecture, and implementation planning. We provide expertise across Tier 1 platforms like Veeva and Tier 2 solutions, including Zen QMS, Montrium, Dot Compliance, and Kivo, ensuring your technology choices align with both current compliance needs and future scaling requirements.

Validation & CSV Excellence

Establish robust Computer System Validation (CSV) processes that ensure regulatory compliance while maintaining operational agility. Our comprehensive validation approach covers Part 11 Electronic Signature requirements, data integrity protocols, and ongoing validation maintenance, creating the right level of documentation to meet regulatory requirements.

Compliance Framework Integration

Build integrated compliance frameworks that connect your GxP systems with broader quality, regulatory, medical, and clinical operations. We design processes that ensure seamless data flow between validated systems while maintaining audit trails, access controls, and change management protocols that support regulatory submissions and inspections.

Ongoing System Governance

Maintain validated state through structured governance processes that address system changes, user access management, and performance monitoring. Our governance approach ensures your GxP systems remain compliant throughout their operational lifecycle while enabling the flexibility needed for business growth and evolving regulatory requirements.

Data Integrity & Management

Implement comprehensive data governance strategies that ensure data quality, traceability, and integrity across all validated systems. We establish data lifecycle processes that support everything from clinical data management to commercial operations, ensuring your validated data serves as a reliable foundation for decision-making and regulatory reporting.

The Narala Advantage

The decisive advantages that differentiate Narala's GxP lifecycle management approach from traditional validation consultants and generic IT providers.