100%
Validation Report sign off
QA signed Validation Report issued before every go-live
NetSuite Computer Software Assurance & CSV
Validated NetSuite implementation for life sciences and medical device teams, with full-service Computer Software Assurance and Computer System Validation aligned to FDA, QMSR, and EU GMP expectations.
2 to 4
Weeks to gap assessment
CSA gap assessment delivered before any validation work begins
Cat. 4
Pre-validated module
Archer Part 11 E-Signature Module reduces OQ burden versus custom SuiteScript
02.02.26
QMSR effective date
ISO 13485 incorporated by reference into 21 CFR Part 820
Overview
Validation right sized to risk, focused where regulators look first
Pharma, biotech, and medical device companies on NetSuite face an FDA inspection environment that is more rigorous and more data driven every year. In 2023, 60 percent of FDA Form 483 observations cited inadequate computer controls. The average cost of an FDA consent decree is $50 million. Validation is no longer a documentation exercise. It is the operating posture that determines whether your NetSuite environment survives inspection.
The Archer NetSuite Computer Software Assurance and CSV service delivers end-to-end validation documentation: URS, DQ, IQ, OQ scripts, PQ scenarios, RTM, deviation log, and a QA signed Validation Report before your system goes live. The CSA framework, finalized by FDA in September 2025, allows validation effort to scale with risk rather than apply uniformly. Oracle's SOC 2 Type II report covers infrastructure-level IQ. Archer focuses rigorous scripted OQ where regulators look first: audit trail configuration, e-signature SuiteScripts, role separation, and lot traceability.
Post go-live, change control keeps your system in validated state across every NetSuite upgrade, bundle update, and configuration change. For medical device companies, CAPA, complaint, and change control workflows align to QMSR, effective February 02, 2026, with ISO 13485 incorporated by reference.
Key services and capabilities
End-to-end validation, delivered before your system goes live.
Every artifact your quality team and an FDA investigator can read. No surprises at go-live.
Validation Services
CSA gap assessment
NetSuite environment audited against FDA CSA and QMSR. Every module classified by GxP criticality. Gap memo delivered before work begins.
Validation Services
Full validation package
URS, DQ, IQ, OQ scripts, PQ scenarios, RTM, deviation log, and QA signed Validation Report for FDA inspection readiness.
Validation Services
QMSR and ISO 13485 alignment
CAPA, complaint, and change control workflows aligned to QMSR effective February 02, 2026. ISO 13485, not the old QSR.
Validation Services
Risk based OQ scoping
Oracle SOC 2 evidence covers infrastructure. Scripted OQ focused on GxP critical functions: audit trail, e-signatures, lot tracking.
Part 11 and Controls
Audit trail configuration
Field-level audit trail on all GxP record types capturing user ID, timestamp in UTC, previous value, and new value. Validated per OQ scripts.
Part 11 and Controls
Archer Part 11 E-Signature Module
Pre-validated GAMP Category 4 module with re-authentication, meaning statement, and audit trail. Reduces OQ burden versus custom SuiteScript, which is Category 5.
Part 11 and Controls
Role based access controls
Role separation so record creators cannot approve. Positive and negative OQ test cases per role per 21 CFR 11.10(d).
Part 11 and Controls
Letter of Non-Repudiation
Each e-signature user submits a Letter of Non-Repudiation to FDA per 21 CFR 11.100(c). Archer guides clients through this step.
Regulatory Coverage
Full framework alignment
21 CFR Part 11, QMSR, 21 CFR Parts 210 and 211, FDA CSA Guidance, GAMP 5 Second Edition, and EU GMP Annex 11 and 22.
How it works
From kickoff to validated state in a structured sequence
Six phases. Each produces an artifact your quality team and an FDA investigator can both read.
- 01
Gap assessment
NetSuite environment audited against FDA CSA and QMSR. Every active module, customization, and SuiteScript classified by GxP criticality. Gap memo delivered before any validation work begins, typically within 2 to 4 weeks.
- 02
Validation Plan and URS
Validation Plan and User Requirement Specification drafted before any configuration work. QA approved. The plan defines scope, risk classification, test strategy, and the artifacts that will be produced.
- 03
IQ, OQ, and PQ
Installation, Operational, and Performance Qualification executed with risk-calibrated scripted testing. Infrastructure IQ relies on Oracle's SOC 2 Type II report. Scripted OQ focuses on GxP critical functions: audit trail, e-signatures, role separation, and lot traceability.
- 04
Requirements traceability
Requirements Traceability Matrix completed. Every URS requirement traced through design qualification, test scripts, and documented results. Deviations logged, investigated, and closed.
- 05
Validation Report and go-live
QA signed Validation Report issued, summarizing scope, test results, deviations, and the basis for release. System goes live with full inspection-ready documentation in place.
- 06
Ongoing change control
Change control maintains validated state across every NetSuite upgrade, bundle update, and configuration change. Each change is risk assessed, regression tested where required, and documented to keep the environment inspection ready continuously.
Who it is for
Built for FDA regulated companies on NetSuite
Life sciences and medical device teams that need inspection-ready environments without leaving NetSuite.
Pharma
Inspection ready commercial operations
Pharmaceutical companies on NetSuite need validated environments before commercial distribution and ongoing change control to maintain audit confidence.
Biotech
IND to commercial validation
Biotech companies moving from IND to commercial need validation infrastructure in place before first commercial shipment. CSA aligned scoping shortens the timeline.
CDMO
Multi-client GxP execution
CDMOs supporting multiple regulated clients need a validated NetSuite environment with lot traceability, batch records, and Part 11 e-signatures.
Medical Device
QMSR alignment by February 02, 2026
Device companies need CAPA, complaint, and change control workflows aligned to QMSR, with ISO 13485 incorporated by reference into 21 CFR Part 820.
Cell and Gene Therapy
Chain of custody and traceability
Cell and gene therapy operations require granular lot traceability, chain of identity controls, and Part 11 compliant audit trails at the transaction level.
Radiopharmaceuticals
DEA, NRC, and FDA coverage
Radiopharmaceutical companies face overlapping FDA, DEA, and nuclear regulatory requirements that demand validated controls and audit-ready documentation.
FAQ
Frequently asked questions
Common questions from quality, IT, and regulatory affairs teams at FDA-regulated companies.
What is Computer Software Assurance (CSA)?
Computer Software Assurance (CSA) is the FDA's current risk-based framework for assuring that production and quality system software performs as intended. Finalized in FDA guidance issued September 24, 2025 and updated February 3, 2026, CSA replaces the documentation-first approach of traditional CSV with a critical-thinking, risk-proportionate model that scales testing and documentation to the actual risk the software poses to product quality and patient safety.
How does CSA differ from CSV?
Computer System Validation (CSV) is the traditional lifecycle approach requiring extensive scripted testing and documentation across all system components. Computer Software Assurance (CSA) applies critical thinking to concentrate validation effort where risk is highest. Under CSA, Oracle's SOC 2 Type II report can be used as supplier evidence for applicable infrastructure-level IQ items, while scripted OQ concentrates on GxP-critical functions. CSA does not eliminate the requirement for a QA-signed Validation Report before go-live.
Does NetSuite require validation for FDA-regulated companies?
Yes. Any computerized system used to create, modify, maintain, archive, retrieve, or transmit records required by FDA predicate rules must be validated. NetSuite used to manage GxP records, including batch records, lot traceability, CAPA, complaints, or quality system documentation, is in scope under 21 CFR Part 11, 21 CFR Parts 210/211, or 21 CFR Part 820 (QMSR). Under GAMP 5 Second Edition (2022), NetSuite is classified as a Category 4 configured commercial software product.
What validation documentation is required for NetSuite?
A complete NetSuite validation package includes: User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) scripts, Performance Qualification (PQ) scenarios, Requirements Traceability Matrix (RTM), deviation log, and a QA-signed Validation Report. Under the FDA CSA framework, applicable infrastructure IQ items may be satisfied using Oracle's SOC 2 Type II report as supplier evidence, concentrating scripted testing on GxP-critical functions.
What is QMSR and how does it affect NetSuite?
The Quality Management System Regulation (QMSR) is FDA's amended 21 CFR Part 820, effective February 2, 2026, which incorporates ISO 13485:2016 by reference as the primary QMS requirement for medical device manufacturers. If NetSuite manages CAPA records, complaint handling, change control, or other quality system processes required by the QMSR, those workflows must be validated. Archer's Quality Management System for NetSuite provides pre-built CAPA, complaint, and change control workflows aligned to the regulation. Explore Archer QMS.
Is NetSuite 21 CFR Part 11 compliant?
NetSuite provides the technical controls necessary to support 21 CFR Part 11 compliance, including audit trail capabilities, role-based access controls, and electronic signature functionality. Part 11 compliance is the regulated organization's responsibility. Compliance requires validated configuration of those controls, documented OQ testing, role separation, and certification to FDA under 21 CFR 11.100(c). Archer's Part 11 E-Signature Module, developed to GAMP Category 4 principles, provides a documented qualification path that reduces OQ burden compared to custom SuiteScript implementations.
Ready to get inspection ready?
Bring validated NetSuite into your operations
Talk with Archer about the validation artifacts, controls, and change-control path for your NetSuite environment.