GxP Audits, CSV / CSA,
and AI-Enabled Compliance
Solutions for Life Sciences.
Liten Solutions helps regulated organisations assess compliance gaps, validate critical systems, and deploy bespoke AI agents, bots, and on-prem solutions where automation can safely improve quality, regulatory, and operational workflows.
Built for inspection-intensive environments.
We start with compliance risk, validation maturity, and operational bottlenecks, then define the right remediation and automation path.
Independent GxP audit support built to identify gaps before regulators do.
We support GMP, GLP, and GCP audit activities across manufacturing sites, laboratories, suppliers, and digital vendors, with practical output your teams can act on quickly.
What we cover
Where it fits
Audit work often becomes the starting point for broader remediation, validation, policy, and workflow improvement activities across regulated organisations.
Validation support for systems that have to stand up under real audit scrutiny.
We deliver end-to-end validation and software assurance support across laboratory, manufacturing, infrastructure, and enterprise systems, using a practical and inspection-aware approach.
Systems and scope
What clients get
A clear validation story, inspection-ready documentation, and support that bridges implementation, remediation, and quality review rather than treating them as separate worlds.
Bespoke AI-enabled solutions shaped by audit findings and operational reality.
We identify repeatable workflow and documentation pain points through audit and validation work, then shape the right AI approach around them without losing compliance focus.
Where AI can help
How we approach it
Every AI discussion starts from the compliance need, the workflow, the controls, and the validation implications — not from the technology alone.
Compliance expertise first, with modern delivery thinking behind it.
Liten Solutions combines deep GxP audit and CSV experience with a practical understanding of how modern AI can support regulated operations where it genuinely adds value.
Expert-led credibility
Led by an ASQ Certified Quality Auditor with 13+ years of experience across QA, CSV, GxP compliance, technical writing, vendor audits, and regulatory support.
System depth
Experience spans SAP, TrackWise, QMS, DMS, BMS, EMS, PLC, SCADA, MES, laboratory systems, ERP, serialisation, and data centre environments.
Global delivery
With a footprint across USA, Ireland, Italy, and India, we support regulated organisations across major compliance jurisdictions.
Get in touch.
Share your audit, validation, or AI workflow challenge. We will review your message and respond with the most relevant next step for your environment.