What IQ/OQ equipment qualification costs
A bought IQ/OQ template costs $99 to $150, and you complete it yourself. A validation consultant's published federal rates run $113 to $199 an hour. A manufacturer's IQ/OQ service costs about $1,500 to $2,100 per benchtop unit, and an engineer on your own team about $64 to $80 an hour.
Below are the four ways labs qualify GMP equipment, what each costs and what each leaves for you to do. Every figure links to the page it came from.
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An engineer on your own team
Most labs write and run their IQ/OQ in house, in Word and Excel. The cost is the engineer's salary plus benefits.
At 2,080 hours a year, those salaries come to about $64 to $80 an hour once benefits are added. That is our arithmetic, not a published rate, and it leaves out the reviewer's and the approver's time.
- Validation Engineer III, US median salarySalary.com$114,519 a year
- Validation Engineer, US median salaryPayscale$91,000 a year
- Wages as a share of employer cost, management and professional workersUS Bureau of Labor Statistics, ECEC June 202668.5%
A validation consultant
A CQV firm drafts and executes the protocol for you. Consultancies quote per project, so the most citable rates are the ceilings a GxP validation firm has on its US federal schedule.
These are federal ceiling rates, the most the firm may bill the US government. Commercial rates are set separately. Your own team still reviews and approves the work.
- Validation Engineer IGSA CALC+, ProPharma Group contract 47QRAA19D00BM$112.84 an hour
- Validation Engineer IIGSA CALC+, ProPharma Group contract 47QRAA19D00BM$125.07 an hour
- Validation Engineer IIIGSA CALC+, ProPharma Group contract 47QRAA19D00BM$132.01 an hour
- Senior Validation ConsultantGSA CALC+, ProPharma Group contract 47QRAA19D00BM$167.19 an hour
- Project ManagerGSA CALC+, ProPharma Group contract 47QRAA19D00BM$198.96 an hour
The manufacturer's IQ/OQ service
Many manufacturers sell an IQ/OQ service or document pack for their own instruments. US prices published for benchtop instruments run from about $1,500 to $2,100 a unit.
Each of these qualifies the manufacturer's instrument against the manufacturer's specification. None of the pages says it covers a user requirements specification, a risk assessment or an SOP, so those, and the review and approval of the manufacturer's report, stay with you.
- Eppendorf microcentrifuge, on-site IQ/OQEppendorf US eShop$1,494
- Eppendorf refrigerated multipurpose centrifuge, on-site IQ/OQEppendorf US eShop$2,062
- Eppendorf Mastercycler, on-site IQ/OQEppendorf US eShop$1,744
- Mettler Toledo EQPac, analytical balance install with IQ/OQ/PQ documentsScales Galore (reseller)$1,508.64
- Memmert IQ/OQ document with factory dataProfiLab24 (reseller)€1,249 before VAT
A bought template
Generic IQ/OQ templates in Word cost little. You still fill in every requirement, test and acceptance criterion for your instrument.
- GMP WebSource IQ and OQ protocol templateGMP WebSource$150
- ISO Cloud Consulting IQ/OQ/PQ process validation packISO Cloud Consulting$99
One new model, one unit
Our estimate is 67 hours of active work to validate one new model and run its IOQ on one unit: 46 for the URS, risk assessment, IOQ and SOP, and 21 to execute and close out. At the rates above, that comes to:
The hours are ValDoc's estimate from its workflow model, not an industry benchmark. We found no published figure to confirm or contradict them. Travel and your own review time are not included.
One model, one unit
67 hours
- In house, at $64 to $80 an hour$4,288 to $5,360
- A consultant, at $125.07 to $167.19 an hour$8,380 to $11,202
The same work in ValDoc
ValDoc drafts the URS, risk assessment, IOQ and SOP and runs the IOQ at the bench. On the same estimate, the work falls from 67 hours to 30: 46 to 19 for the documents, and 21 to 11 to execute and close out. A qualified person still reviews, edits and signs every document, and your team or contractor still runs each test at the bench with calibrated instruments.
Thirty minutes. Bring one piece of equipment.
46 hours today, 19 with ValDoc:
URS, RA, IOQ and SOP, per new model
21 hours today, 11 with ValDoc:
Execution and close-out, per unit
Prices change. Follow each link for the current one; the date above is when every figure was last checked.
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.