- Validate 130 environmental storage chambers
- 4 month deadline
- Customer-designed protocols for 40 chambers
- Masy-designed protocols for 90 chambers
- Masy Quality Department reviews all documents
- 2 Validation Project Leaders
- 4 Validation Technicians
- 1 Quality Review Specialist
- 12 Kaye Validator 2000s
- 24 Kaye SIMs
- 3 Kaye IRTDs
- 3 Kaye LTR-140 Dry Wells
- 192 Masy Ultra-Premium Type T Thermocouples
- 3 months to complete vs. 4 months quoted
- Final billing under quote / purchase order
Masy BioServices successfully validated 130 chambers, beating the deadline and the budget, despite several obstacles.
Preliminary analysis showed that nearly 60% of the chambers would fail validation, but with customer approval, Masy made adjustments to bring those chambers within the specified tolerance. This saved the customer significant time and money.
None of the chambers were connected to the customer’s monitoring system during validation, requiring an addendum to each report when chambers were re-connected.
As the validation reports were not allowed off-site, report quality review required bringing a Masy quality review specialist on-site.
All work was completed and final validation reports were submitted before the customer’s due date. The customer found no errors in our documentation.
This customer continues to call Masy regularly for validation projects. Over time, Masy has earned enough trust to allow validation reports to be taken off-site for review at Masy corporate headquarters.