Validate and Maintain
Transport system validation: URS and IQ/OQ
Validating a transport system means writing a URS for its intended use, assessing the risks, then running an IOQ. The IQ confirms it was installed as specified, and the OQ proves it performs, with tests such as Temperature Performance Study (Summer Profile), Temperature Performance Study (Winter Profile) and Maximum Duration / Hold Time Study.
An insulated shipper, cold-chain container, dry shipper or other packaging that holds conditions while material is moved. ValDoc drafts the URS, risk assessment, IOQ and SOP from the intended use you state, runs the IOQ at the bench and keeps its maintenance on the same record. It does not draft the PQ, which depends on your process. You write that as your own Protocol.
Last updated
Thirty minutes. Bring one piece of equipment.
What the URS specifies
ValDoc's URS for a transport system starts from 16 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Operating parameters1
- Shipment temperature condition
Performance1
- Qualified temperature hold time
Capacity & dimensions4
- Payload capacity
- External dimensions
- Empty weight
- and 1 more
Design & construction4
- Transport type
- Cooling method
- Insulation type
- and 1 more
Alarms & monitoring4
- Data logger included
- External monitoring capability
- Alarm capability
- and 1 more
Operating environment1
- Storage condition when not in use
Maintenance & serviceability1
- Preconditioning required
What the IOQ tests
ValDoc's starting protocol has 18 test cases: 9 installation and 9 operational. A few from each phase are below, and your team reviews and edits every test before the protocol is approved.
Installation qualification9
- Settings Verification
- Equipment Condition Check
- System Information & Nameplate Verification
- and 6 more
Operational qualification9
- Temperature Performance Study (Summer Profile)
- Temperature Performance Study (Winter Profile)
- Maximum Duration / Hold Time Study
- and 6 more
Regulations that can apply
ValDoc's library holds 8 regulations from US and EU sources that can apply to a transport system URS, including 21 CFR Part 11, EudraLex Volume 4, Annex 11 and EudraLex Volume 4, Annex 15. Which of them apply depends on its intended use.
United States4
European Union4
Maintenance and calibration
Maintain proposes 3 plans for a transport system, and you confirm each cadence against the manual and your SOP. Each unit gets its own schedule and history, on the same record as its qualification. Maintain also offers 4 plans any family can use, such as Electrical Safety Inspection.
PM
Every 1 year
Dry Shipper Static Hold Time Verification
PM
Every 6 months
Reusable Passive Shipper Integrity Inspection
PM
Every 1 year
Active Shipper Refrigeration and Battery Preventive Maintenance
Other equipment
ValDoc can still support equipment that is not on this list. Adding the equipment families a lab needs is part of onboarding, so tell us what you run.
- Biosafety Cabinets
- Controlled Temperature Units
- Incubators
- Centrifuges
- Environmental Monitoring
- Thermal Sealing and Welding Systems
- Weighing Devices
- Liquid Handling Equipment
- Cryogenic Systems
- Stability Chambers
- Sterilization Equipment
- Label Printers
- Vacuum Pumps
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.