Enterprise Software Solutions
SIGAssurance Delivers Evidence-Based Software Validation for Life Sciences Manufacturers
Vendor software releases don't have to break your validated state. Strategic Information Group delivers pre-built validation evidence packages for QAD and NetSuite ERP systems, so your quality team never starts from scratch — minimizing validation timelines and freeing up quality resources for higher-value work. Our validation consultants bring decades of life sciences expertise to every supported release, applying FDA Computer Software Assurance principles to reduce validation burden and keep you audit-ready.
SIGAssurance at a Glance
Strategic has partnered with regulated manufacturers for more than 30 years. Our SIGAssurance model solves a persistent problem — validation work repeated across companies, releases and environments. We build baseline validation evidence once per supported release and deliver it to participating clients, reducing redundant validation work and delivering faster speed to value on ERP investments.
Modern cloud ERP addresses these challenges by centralizing operations:
Coverage: QAD Adaptive, EQMS, Automation Solutions and NetSuite.
Delivery model: Pre-built evidence packages for supported releases.
Approach: FDA CSA-aligned, risk-based validation.
Experience: 30+ years serving life sciences and regulated manufacturing.
Release-ready advantage: Baseline evidence arrives before you upgrade.
Keep Your Quality System Audit-Ready Through Every ERP Release
QAD and NetSuite releases introduce workflow changes, calculation updates and reporting modifications that your quality system depends on. Without re-establishing evidence that software still performs as intended, you face compliance gaps that surface during audits.
Quality-critical data flows through your ERP, including device history records, batch genealogy and lot traceability. When vendor updates affect these functions, regulatory agencies expect documented evidence that controls remain intact. Traditional validation forces quality teams to rebuild validation documentation with every release.
Strategic's validation packages give your team a foundation. We handle baseline software evidence. You focus validation efforts on your specific products, processes and environment.
How FDA CSA Transforms the Validation Model
FDA Computer Software Assurance guidance encourages risk-based validation, emphasizing critical thinking over scripted testing. CSA directs validation efforts toward areas where software failure would affect product quality or patient safety.
How Strategic delivers validation evidence: We scale testing effort based on patient and product risk, leveraging vendor testing when the rationale supports it. Core evidence gets built once per supported release and delivered to participating clients.
Traditional CSV limitations: Extensive scripted testing gets applied uniformly regardless of risk level. Vendor testing remains underutilized. Validation work gets repeated for each client, environment and release.
Your team's focus: Strategic's approach reduces validation burden while supporting regulatory confidence. Your quality team can redirect effort toward areas where it creates the most value.
The SIGAssurance Delivery Model
Strategic builds baseline validation evidence against each supported vendor release. The same package gets delivered to every participating client, eliminating redundant validation work. You receive pre-built evidence when you're ready to upgrade, accelerating upgrade timelines and reducing project risk.
Available validation packages include:
SIGA / QAD-ADAPTIVE: Evidence-based QAD validation for standard QAD Adaptive core ERP functionality across supported releases.
SIGA / QAD-EQMS: Validation evidence for the quality management system your audit trail depends on.
SIGA / QAD-AUTOMATION: Evidence for automation-layer functionality connecting QAD with shop floor and warehouse execution.
SIGA / NETSUITE: Evidence-based NetSuite validation applying the same shared-evidence model to NetSuite's release cadence.
Strategic also supports QAD integrations and add-ons that extend ERP capabilities.
What You Receive: QAD Adaptive Package
Strategic delivers a baseline validation evidence package for standard QAD Adaptive (Core ERP) functionality, excluding client-specific configurations.
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Strategic provides the validation documentation and protocols you need to establish regulatory confidence.
Validation Plan with defined scope and acceptance criteria.
Risk Assessment and Requirements Traceability Matrix.
Operational Qualification (OQ) Protocol with execution evidence from a controlled reference environment.
Configuration Specification baseline and Performance Qualification (PQ) Protocol template.
GxP Standard Operating Procedures covering critical processes.
Templates and work instructions to support implementation.
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Your team completes the environment-specific validation work that connects our baseline evidence to your actual operations.
Quality Assurance (QA) and regulatory review and approval.
Configuration Specification updates reflecting your environment.
Performance Qualification against your products and processes.
Validation Summary Report sign-off.
SOP implementation and user training.
Ongoing change control and periodic review.
Release documentation updates align with supported QAD release schedules. Our QAD consulting services team supports implementation and optimization alongside validation delivery.
Your Team Owns Environment-Specific Validation
Strategic's evidence covers software as the vendor delivers it. Performance Qualification remains with your team because only you can validate how software performs against your products, processes and environment. Strategic provides baseline evidence, and your team completes PQ protocols tied to your actual operations.
Extend Validation With Managed ERP Support
Strategic's SIGSERV managed services and NetSuite Customer Care provide 24/7/365 technical monitoring and application support for validated systems. Our onshore consultants understand regulated manufacturing requirements and help maintain system control between releases.
For organizations running earlier QAD versions or platforms outside our standard package lineup, our continuous validation services team can scope custom engagements.
Partner With Our Life Sciences Validation Specialists
Strategic Information Group has delivered software validation services to life sciences manufacturers for more than 30 years. Our consultants bring deep regulated manufacturing experience, understanding device history record requirements, batch genealogy traceability, GMP data integrity controls and quality system standards your auditors expect.
Ready to stop validating from scratch? Connect with our validation team to discuss your platform and release schedule.
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