How Compliance-Driven Warehouses Get Operational Fast
Don’t let complexity slow you down. A warehouse ASRS is only as powerful as its commissioning and qualification process. Without it, you risk compliance failures, costly downtime, and delayed ROI. Performance Validation brings cGMP knowledge, CQV expertise, and hands-on experience with automated warehouse storage and retrieval systems to get you operational quickly and in full regulatory compliance.
Deep ASRS Storage Expertise. Proven Results.
Not all commissioning partners understand the complexity of a warehouse ASRS in a regulated environment. We do.
- Deep understanding of business and quality drivers, collaborating effectively across multi-functional teams.
- Knowledge of global regulatory frameworks, including EN 2500 and GAMP.
- Expertise in commissioning warehouses, including envelope security and supporting utilities.
- Qualification of Storage and Retrieval Machines (SRMs), auxiliary equipment, and Automated Guided Vehicles (AGVs).
- Understanding the role of various control systems for AGVs and SRMs, including Warehouse Management Systems (WMS), Warehouse Control Systems (WCS), and Warehouse Execution Systems (WES).
- Experience with both high-volume/low-mix and low-volume/high-mix storage environments.
- Insight into how ASRS systems integrate across the manufacturing workflow.
- Expertise in integrating ASRS with AGVs and within existing manual or hybrid warehouse ecosystems.
- Expertise in verifying environmental conditions for new stores. Test strategies include unloaded and fully loaded conditions.
Performance Validation’s ASRS Qualification Process:
DESIGN PHASE
ENGINEERING SHAKEDOWN
TEMPERATURE MAPPING
FORMAL TESTING
GO LIVE
The best time to bring PV in is during the system design phase. We collaborate with your engineering teams and ASRS storage vendors early to align on user requirements, material flow, and qualification scope. We also draw on past project experience to flag potential design issues before they become costly problems.
Before formal testing begins, we dry-run all test cases to verify your warehouse ASRS functions as designed. We go beyond what vendors typically test by covering end-to-end material flow scenarios, AGV integrations, and worst-case stress conditions. When issues arise, our team will investigate, identify root causes, and drive fast solutions.
Temperature mapping an ASRS storage environment is more complex than a conventional warehouse. We use proven strategies to get loggers to the right locations efficiently. With 1,000+ calibrated data loggers and proprietary analysis tools, we map both empty and simulated full-load conditions.
With shakedown complete, we execute structured CQV testing across modules, complete systems, and supporting utilities — including information technology computer system validation for ERP systems and operational technology computer system validation for control systems — with full documentation and risk assessments designed to withstand regulatory scrutiny.
We don’t just hand over a report; we support your team through go-live, ensuring your automated storage and retrieval system transitions seamlessly into validated, production-ready operation.
ASRS Services Tailored to Your Needs
Regulatory & Consulting
- Regulatory framework consulting
- Risk-based strategies
Testing & Qualification
- Factory Acceptance Testing (FAT) support and engineering shakedown testing
- CQV of modules, complete systems, and supporting utilities
- Information technology computer system validation of Enterprise Resource Planning (ERP) systems and operational technology computer system validation of control systems, including risk assessments, documentation, and execution
Environmental & Compliance
- Maintenance and turnover package (TOP) creation
- Building Commissioning (BCx), including envelope integrity
- Environmental mapping with a fleet of >1,000 calibrated data loggers
- Deviation investigation
Case Study: ASRS Qualification
The Challenge
A large midwestern pharmaceutical company needed to qualify a new automated storage and retrieval system within a chilled storage facility. The ASRS storage vendor had no prior pharmaceutical industry experience, and qualification faced a hard, shutdown-driven deadline to accommodate product transfer from an existing qualified space.
The Solution
PV developed a comprehensive commissioning and qualification (C&Q) plan, working directly with the client and vendor to define scope, build test cases, and execute an extensive engineering shakedown. Our team’s deep system expertise proved critical when issues arose, driving fast root-cause resolution and keeping the project on schedule.
The Results
The automated storage and retrieval system was qualified on time, enabling a seamless product transition into the newly validated space. The client’s ASRS storage system now serves as an organizational model for storage and retrieval efficiency.
“I always request to have PV involved in our ASRS projects. They understand the intricacies of the system and are very thorough in their testing. We have a high level of trust in the work that they do, and they consistently deliver.” — ASRS Project Lead, Global Pharma Manufacturer
Ready to Bring Your ASRS Storage System Online?
Don’t let complexity slow you down. PV brings cGMP knowledge, CQV expertise, and hands-on experience with automated warehouse storage and retrieval systems to get your project done right.
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