CSV for GxP
GxP is an umbrella for Good Practice domains across the product lifecycle. CSV principles remain consistent, but risks differ across manufacturing, distribution, clinical research, and safety monitoring.
GMP systems control manufacturing, batch release, and quality testing. CSV ensures production and QC software consistently deliver the specifications required for product quality.
Typical systems include MES, batch record systems, LIMS, and process control platforms.
GDP focuses on maintaining product quality during storage and distribution. Validation covers warehouse management, temperature monitoring, and shipment tracking to protect chain of custody.
Systems must prove traceability, excursion handling, and release decisions are controlled and auditable.
GCP systems manage clinical trial data and subject safety. CSV verifies that electronic data capture, randomization, and trial management tools preserve data integrity and confidentiality.
Validation aligns to the reliability of trial outcomes and protection of participant rights.
GVP systems collect and assess adverse event data. CSV confirms accurate intake, triage, and reporting workflows for global safety obligations.
Audit trails, controlled access, and data integrity protections are essential for safety reporting.
GLP applies to non-clinical laboratory studies. Validation focuses on laboratory data systems, ensuring results are accurate and reproducible.
LIMS, instrument data systems, and reporting tools often require validation and data integrity controls.
Across all domains, CSV aligns requirements, testing, and evidence with risk. The difference is which functions are critical to quality and safety. Use the regulatory foundations to anchor your approach.
Need a structured plan? Review the validation lifecycle.
Whether you manage manufacturing, distribution, clinical, or safety systems, CSV should focus on the functions that influence product quality and patient safety. We tailor validation scope to match your GxP risks.