CSV for 3PL: Ensuring Compliance for cloud-based
& on premise Software systems
For Third-Party Logistics (3PL) providers working with pharma, cosmetics or other GMP-regulated industries, software validation is essential for compliance. Regulations such as 21 CFR Part 11, EU Annex 11 and EudraGMDP set strict requirements for data integrity, electronic records & signatures and product quality.
Whether you’re implementing a new Enterprise Resource Planning system (ERP), upgrading your Warehouse Management System (WMS) or ensuring compliance for your SaaS solutions, our validation process is tailored to minimize risk and maximize efficiency.
Risk-based & efficient validation approach
Criticality Assessment
- Identify critical software within your 3PL operations.
- Analyze interactions between ERP, WMS and other key systems.
- Map out high-level process flows (warehouse, supply chain, etc.).
Validation Planning
- Define roles, responsibilities, scope and regulatory references.
- Establish necessary deliverables (URS, IQ, OQ, PQ).
- Plan deviation management strategies.
Test Protocol Development & Execution
- Installation Qualification (IQ): Software & hardware verification, security settings and access control.
- Operational Qualification (OQ): Functional testing, network communication, audit trail verification.
- Performance Qualification (PQ/UAT): User-driven testing to ensure real-world functionality.
Traceability & Reporting
- Link requirements to execution steps through a structured Traceability Matrix.
- Deliver a comprehensive validation report, listing deviations, resolutions and system release approvals.
Proven Expertise in CSV for 3PL
GXP ASSESSMENT & VALIDATION
A manufacturer of plastic components for medical applications required GxP validation of its ERP, MES, and EAM systems to ensure compliance with GMP regulations.
Agidens conducted a risk-based assessment, identifying critical software modules, mapping data and process flows, and evaluating compliance with electronic records, signatures, and data integrity.
The validation approach included:
- GxP criticality assessment: Identifying compliance risks
- Validation planning: Defining validation scope and deliverables
- Risk-based qualification: Ensuring validation of high-risk system areas
By implementing a structured validation strategy, the manufacturer optimized calibration data management, production workflows, and supply chain processes—ensuring compliance without excessive documentation. The result was a fully validated system infrastructure that supports regulatory requirements while maintaining operational efficiency.
COMPLIANCE FOR SAP & LIMS
A global food manufacturer producing infant formula must comply with strict FDA (21 CFR) and EU GMP regulations. To ensure regulatory alignment, the company required validation of its SAP and LIMS systems to manage GMP-critical data and safeguard product safety and traceability.
Agidens conducted a GxP Gap Analysis, focusing on:
- GMP-critical functions: Identifying processes impacting product quality and patient safety
- Risk-based validation: Categorizing systems using GAMP 5 to define compliance requirements
- Traceability & data integrity: Ensuring compliance with batch tracking and sterility verification
By applying a targeted, risk-based validation approach, the manufacturer achieved regulatory compliance without unnecessary complexity. This ensured data integrity, maintained operational efficiency, and supported product quality across both production and logistics systems.
ICT Validation & ERP Compliance
A manufacturer of molecular diagnostic solutions relied on Agidens for the validation of its ICT off-the-shelf applications to ensure compliance with GxP and 21 CFR Part 11 requirements.
Agidens managed the planning, execution and follow-up of all validation activities, taking full responsibility for drafting and maintaining the ICT Validation Master Plan, as well as Standard Operating Procedures (SOPs) and Work Instructions (WIs) relevant to ICT systems.
In addition, we conducted a GxP criticality assessment, identifying which applications required qualification and oversaw the validation documentation to support regulatory readiness.
Our experienced consultants also handled the ERP system validation for Microsoft Dynamics AX2012 and acted as QA lead during the implementation of the cloud-based Dynamics 365 SaaS platform. Further validation activities were carried out for additional critical systems such as SLIMS, INTUO and Salesforce CRM.
The result was a fully documented, validated IT landscape that met strict life sciences compliance standards.
Why Agidens for your CSV?
Whether you’re implementing a new ERP system, upgrading your WMS or ensuring compliance for your SaaS solutions, our validation process is tailored to minimize risk and maximize efficiency.
Compliance with FDA, EU GMP, WHO and other global regulations.
Targeted validation, eliminating unnecessary documentation.
From user requirements to system release.
Ensuring validated interoperability between your software systems.
Stay Compliant, Stay Ahead
Planning an ERP or WMS upgrade? Expanding your GMP-regulated logistics services? Ensure your Computer System Validation is streamlined and compliant.
Contact us today for a consultation and secure your validation strategy.
