Validate and Maintain
Label printer validation: URS and IQ/OQ
Validating a label printer 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 Print and Barcode Quality Verification, Label Alignment Verification and Interface and Data Transmission Verification.
A label printer prints labels and barcodes (thermal transfer or direct thermal industrial and desktop printers). 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.
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Thirty minutes. Bring one piece of equipment.
What the URS specifies
ValDoc's URS for a label printer starts from 30 requirements in 7 groups. You choose which apply and set each value. A few from each group are below.
Performance4
- Print resolution
- Barcode symbologies
- Print accuracy tolerance
- and 1 more
Capacity & dimensions2
- Print width range
- Media width range
Design & construction8
- Printer type
- Print method
- Media type compatibility
- and 5 more
Control & interface6
- Interface ports
- Display and HMI type
- Adjustable print speed
- and 3 more
Utilities & installation2
- Supply voltage
- Maximum amperage requirement
Operating environment2
- Operating temperature range
- Operating humidity range
Maintenance & serviceability6
- Ribbon type
- Ribbon coated side
- Ribbon wound orientation
- and 3 more
What the IOQ tests
ValDoc's starting protocol has 15 test cases: 9 installation and 6 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 qualification6
- Print and Barcode Quality Verification
- Label Alignment Verification
- Interface and Data Transmission Verification
- and 3 more
Regulations that can apply
ValDoc's library holds 8 regulations from US and EU sources that can apply to a label printer 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 label printer, 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
Label Printer Verification
PM
Every 6 months
Label Printer Printhead and Media Path Maintenance
PM
Every 1 year
Barcode Readability Verification
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
- Transport Systems
- 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.