GxP Compliance and Computerized System Validation (CSV)
Risk-based validation, ALCOA+ data integrity, and inspection-ready evidence for GMP, GLP, GCP environments.
What is GxP ?
GxP is the umbrella for Good Practice regulations in life sciences that safeguard product quality, patient safety, and data integrity. In digital environments, GxP drives computerized system validation (CSV/CSA) and alignment with EU Annex 11 and FDA 21 CFR Part 11, ensuring ALCOA+ data integrity and inspection-ready evidence across the system lifecycle.
What GxP Means For Digital Systems?
CSV/CSA
Risk-based validation with requirements, testing, and summary reports.
SOPs & Training
Role-based procedures and competence for validated operations
Change Control & Periodic Review
Impact assessment, re-validation, and continued state of control
ALCOA+ Data Integrity
Attributable, Legible, Contemporaneous, Original, Accurate + complete, consistent, enduring, available
Annex 11 & 21 CFR Part 11
eRecords/eSignatures, identity, time stamps, and record lifecycle
Audit Trails & Access Control
Enabled, reviewed, and time-synchronized
Signals It’s Time to Act
Key indicators that GxP compliance, CSV/CSA, Annex 11, and 21 CFR Part 11 controls need attention — before inspection exposure and validation risk escalate
Upcoming release or major change to a GxP-impact system
Migration to cloud/SaaS or vendor change
Annex 11 / 21 CFR Part 11 gaps or audit findings
Incomplete SOPs, traceability, or test evidence
Need for data integrity controls (ALCOA+) and audit trails
New market entry or notified inspectorate visit
What We Provide
Readiness and Gap Assessment
CSV / CSA Execution
Data Integrity (ALCOA+)
eRecords and eSignatures
QMS and SOPs
Audit / Inspection Preparation
Training and Enablement
Timelines & Effort
Readiness
Sprint
2–4 weeks
Scope, Gaps, Roadmap
System
Validation
6–12 weeks
per critical application
Continuous
Compliance
Quarterly / periodic reviews
based on change impact
GxP Core Domains We Cover
GMP
Good Manufacturing Practice
Controls for production, release, and quality systems
GLP
Good Laboratory Practice
Reliable, traceable non-clinical laboratory data
GCP
Good Clinical Practice
Ethical, high-quality clinical data and subject protection
Achieve GxP Compliance with Confidence
Risk-based validation and data integrity controls aligned to Annex 11 and 21 CFR Part 11 — delivered with clear evidence and pragmatic documentation.
FAQs
Discover clear answers to common questions on GxP expectations, scope, and evidence.
Any software or process that can affect product quality, patient safety, or data integrity in GMP/GLP/GCP environments is considered GxP-impact and requires validation and control.
CSV emphasizes documented validation.
CSA computer software assurance applies a risk-based approach to focus testing where it matters most while maintaining inspection-ready evidence.
Define role-based responsibilities and frequency, sample critical records, verify completeness/immutability/time stamps, and document outcomes with CAPA where needed.
After changes that affect intended use, risk profile, configuration, integrations, or data flows—plus periodic reviews to confirm continued state of control.