In the September 4th edition of Device Daily, it was reported that the FDA cited Dharma Research, for failing to validate the storage conditions for its Etchant gel.
Don’t let this happen to you.
Performance Validation (PV) has completed hundreds of mappings including Sub-freezers/cryogenic storage, USP Freezers, USP cold storage or chill rooms, and distribution warehouses. See examples of the types of projects completed on the Environmental (Temperature/Humidity) Mapping section of our Project Summaries Page.
Mapping Capabilities – Performance Validation’s equipment is maintained in a calibrated and validated state. We have Vaisala wireless data logger and Kaye wired systems for temperature and humidity mapping. Our equipment inventory also includes self contained biological indicators and an incubator for verification of sterility processes. Our internal procedures have been developed to govern the use of equipment to ensure a consistent approach to equipment set up and data retrieval.
Mapping Competencies – Performance Validation has provided environmental mapping support to hundreds of clients across multiple industries for wide ranging applications.
How we can help – Performance Validation has the flexibility and experience to offer varying levels of support, depending on our clients’ resources and capabilities.
- Turn-key Solutions: Onsite project completion from strategy, to document development, thru mapping execution, and problem resolution.
- Off-Site Support: Our mapping protocol templates, based on industry standards, can be utilized along with off-site programming and downloading of data loggers for a cost effective yet compliant solution.
- Equipment rental: Want to DIY your study but don’t have the equipment, Performance Validation rents our temperature mapping equipment to clients for internal execution of Temperature Mapping work
Need peace of mind that your storage conditions meet your requirements for temperature and/or humidity? Use our contact us page at Performance Validation for all of your mapping needs.