IT Enablement & Digital Transformation
Architecting compliant, scalable, and future-ready IT ecosystems aligned with GAMP 5, ITIL, and global regulatory standards to power your life sciences operations.
Our IT Enablement Philosophy
We bridge the critical gap between IT, Quality, and Operations. By integrating best practices from ITIL and ITSM with a profound understanding of GxP regulations (21 CFR Part 11, EU Annex 11), we ensure your technology infrastructure is not just powerful, but audit-proof. Our focus is on creating a robust, secure, and efficient digital foundation that accelerates your business while mitigating compliance risk.
Core IT Enablement Services
GxP System Implementation
Expert implementation, configuration, and validation of mission-critical GxP systems including eQMS, LIMS, DMS, and ERP.
IT Compliance & Governance
Ensuring strict adherence to 21 CFR Part 11, EU Annex 11, and GAMP 5, while implementing robust cybersecurity and data integrity controls.
Digital Transformation Strategy
Developing strategic roadmaps for the migration from legacy systems to modern, digital-first operations.
Business Process Automation (BPA)
Automating key quality and compliance workflows to reduce manual effort, minimize human error, and accelerate GxP processes.
Test Automation & Workflow Validation
Developing automated testing scripts and validating complex digital workflows to ensure system reliability and compliance.
IT Governance & Audits (ITIL, SOC)
Establishing IT governance frameworks based on ITIL/ITSM and preparing for SOC 2 audits to ensure operational excellence.
Ready to Enhance Your Compliance Framework?
Let's build a resilient, efficient, and inspection-ready future for your organization. Schedule a complimentary, no-obligation consultation with our experts to discuss your specific challenges and discover how Akatalyst can be your catalyst for success.
Our Product Suite
Our pre-validated, GxP-compliant software simplifies quality management, with an optional AI layer to unlock next-gen efficiency.
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