How does GAMP 5 risk-based validation differ from traditional CSV?

Traditional CSV applies uniform heavy documentation to everything. GAMP 5 (and the FDA's CSA guidance) scales effort to risk: critical functions receive rigorous scripted testing, lower-risk functions get lighter-touch verification, reducing validation effort while maintaining compliance.

What are IQ, OQ, and PQ?

They are the core qualification stages: Installation Qualification (IQ) verifies the system is installed and configured correctly; Operational Qualification (OQ) verifies it functions as specified across its operating ranges; Performance Qualification (PQ) verifies it performs reliably in intended real-world use. Together they document that a system is fit for GxP use.

Can cloud/SaaS systems be validated?

Yes — the approach shifts toward vendor qualification, configuration verification, and ongoing supplier assurance rather than testing the vendor's infrastructure. We build SaaS qualification strategies that align with regulatory expectations and that vendors can realistically support.

Do you validate legacy systems already in use?

Yes. For systems already in production without adequate validation, we perform a gap assessment and retrospective validation — documenting current state, remediating gaps, and establishing ongoing periodic review to bring the system into a defensible, inspection-ready state.

What is ALCOA+ and why does it matter?

ALCOA+ defines the attributes of trustworthy data: Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. Regulators use it as the lens for data integrity findings, which are among the most common and consequential inspection outcomes.

Division 07

Computer System Validation & Data Integrity

ExcelCSV·Computer System Validation

ExcelCSV keeps your GxP systems compliant and your data defensible — GAMP 5 risk-based validation, 21 CFR Part 11 / Annex 11 compliance, and data integrity assurance that stands up to inspection.

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GAMP 5

Risk-Based Validation

GAMP 521 CFR Part 11EU Annex 11

Validation that enables systems, not bureaucracy that blocks them

Every regulated activity in modern clinical research runs on software: CTMS, eTMF, EDC, safety databases, LIMS. Regulators expect documented evidence that these systems do what they claim, protect data integrity, and control who can do what. ExcelCSV provides that evidence, scaled to actual risk.

We apply GAMP 5's risk-based framework with modern Computer Software Assurance (CSA) thinking: critical functions get rigorous challenge testing, low-risk functions get right-sized verification. The result is compliance that speeds up system adoption instead of slowing it down.

Risk-Proportionate Rigor: GAMP 5 categorization focuses validation effort where patient safety and data integrity actually depend on it.
Part 11 / Annex 11 Fluency: Electronic records, signatures, audit trails, and access controls assessed against both FDA and EU expectations.
Defensible Evidence: Traceable, inspection-ready validation documentation from user requirements to summary report.
Clinical System Focus: Validation built for the systems research runs on — CTMS, eTMF, EDC, safety databases, LIMS — not generic IT.
Modern CSA Approach: Computer Software Assurance thinking that puts testing effort into genuine risk, not documentation for its own sake.
Validated State, Maintained: Change control and periodic review keep systems in a validated state well beyond go-live.

What ExcelCSV delivers

The full validation lifecycle for GxP computerized systems: planning, qualification, compliance, and ongoing assurance.

Validation master plans and system-specific validation plans
URS / FS development and review
GAMP 5 system categorization and risk assessment
Requirements traceability matrix (RTM)
Validation summary reports and system release

How an ExcelCSV engagement runs

A risk-based validation lifecycle aligned to GAMP 5 — scoped, executed, and maintained.

01
System Inventory & GxP Assessment
Systems cataloged and assessed for GxP impact — validation applies where regulation requires it.
02
Risk-Based Planning
GAMP categorization and risk assessment define right-sized validation strategy per system.
03
Protocol Authoring
IQ/OQ/PQ protocols and traceability built against approved requirements.
04
Execution & Deviation Management
Testing executed with controlled deviation handling and documented resolution.
05
Reporting & Release
Validation summary reports support formal system release for GxP use.
06
Periodic Review
Scheduled reviews keep validated state intact through changes, patches, and upgrades.

Why sponsors choose ExcelCSV

Validation at the speed of adoption: Risk-based scoping and CSA thinking help systems reach validated go-live faster, without cutting compliance corners.
Clinical-domain validation expertise: We validate the systems clinical research actually runs on — CTMS, eTMF, EDC, safety databases — not generic IT.
Both sides of the Atlantic covered: One assessment framework addressing FDA Part 11 and EU Annex 11 expectations together.
Validated state that survives change: Change control and periodic review programs keep systems compliant long after go-live.
GAMP 5 and CSA, applied: Current risk-based frameworks (GAMP 5, FDA CSA) applied in practice, not just cited.
Documentation built for inspection: Traceable evidence from user requirements to summary report, structured to be shown to a regulator.

Who We Serve

The organizations ExcelCSV supports

Pharmaceutical Companies
Biotechnology Companies
Medical Device Companies
CROs
Generic & Biosimilar Manufacturers
Clinical Laboratories

Questions, answered

The essentials sponsors ask before engaging ExcelCSV. For anything more specific, our team is one conversation away.

Any computerized system that creates, modifies, maintains, or transmits GxP records — CTMS, eTMF, EDC, safety databases, LIMS, document management, and relevant ERP modules. A GxP impact assessment determines exactly which of your systems are in scope.