DTPro Software Validation

How Mesa Labs Validates DTPro Software

DTPro Software revisions may occasionally be needed to add functionality, fix issues, or remove obsolete aspects. To ensure that our updates meet FDA 21 CFR Part 11 and our own requirements, the software validation effort is a tightly controlled process. Major updates to the DTPro Software require that the software specifications be revised. These specifications…

Validating with DataTrace

Validating with DataTrace

DataTrace data loggers and DTPro software can be used to record and analyze temperature, humidity, and pressure data for numerous applications. The most common uses for DataTrace data loggers and DTPro software are mapping storage and laboratory equipment, sterilizers, and cooking processes for qualification/validation efforts or routine process monitoring. Temperature Data Loggers are used to…

Ensure Compliance

FDA 503B Compliance

In 2013 the FDA instituted the Drug Quality and Security Act which created section 503B of the Federal Food, Drug and Cosmetic (FD&C) Act. Under section 503B compounding facilities can choose to register with the FDA as an outsourcing facility. If a facility is registered with the FDA as an outsourcing facility to produce sterile…

Keep Your Products Safe

Benefits of Temperature Mapping

Current Good Manufacturing Practices (21CFR Part 211) require that raw materials, in-process materials, finished products, stability samples, and components are stored at the correct environmental conditions to maintain the integrity of the products and components. To meet these requirements, temperature mappings of the areas and equipment used to store your products must be completed before…

Validation of Dry Heat Sterilization Processes

Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle…

Validation of a Steam Sterilization Process

If terminal steam sterilization of medical devices, production or packaging components, final pharmaceutical product, or bulk active pharmaceutical ingredients is required, it is necessary that both the sterilization cycle(s) and the autoclave be validated. Validation of the autoclave and the sterilization cycle(s) is required by ANSI, AAMI, ISO, and the FDA to ensure that all…