CSV and CSA

Validated NetSuite implementation for life sciences and medical device teams, with full-service Computer System Validation and Computer Software Assurance aligned to FDA, QMSR, and EU GMP expectations.

100%

Validation Report sign off

QA signed Validation Report issued before every go-live

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 CSV and CSA 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.

  1. 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.

  2. 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.

  3. 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.

  4. 04

    Requirements traceability

    Requirements Traceability Matrix completed. Every URS requirement traced through design qualification, test scripts, and documented results. Deviations logged, investigated, and closed.

  5. 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.

  6. 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.

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.