Temperature Mapping for Summer Months

As the summer months approach, you may need to begin thinking about having your product storage areas temperature mapped. Warehouses should be temperature mapped during both the hottest and coldest times of the year to ensure that the items being stored are being kept at optimal conditions year-round. Mapping storage areas in the summer months…

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…

3 Stages of Validation – Stage 3

There are three stages of the validation process that will help to make sure that your product, process, service, or system meets industry requirements, user specifications, and is able to fulfill its intended purpose. The final step in the validation process is Performance Qualification (PQ). Mesa’s PQ protocols will: Verify that the equipment, previously verified…

Stage 2

3 Stages of Validation – Stage 2

There are three stages of the validation process that will help to make sure that your product, process, service, or system meets industry requirements, user specifications, and is able to fulfill its intended purpose. The second step in the validation process is Operational Qualification (OQ). Mesa’s OQ protocols will: Demonstrate and document that the equipment…

Stage 1

3 Stages of Validation – Stage 1

There are three stages of the validation process that will help to make sure that your product, process, service, or system meets industry requirements, user specifications, and is able to fulfill its intended purpose. The first step in the validation process is completing the Installation Qualification (IQ). The IQ process gathers all documentation proving the…

A Case Study

California Dried Fruit Inc.; a Case Study

California Dried Fruit, Inc. manufactures all-natural dried fruit butters and purees. By manufacturing food products, they are held to the food safety standards of the HAACP. They also hold high standards internally for their product quality. Our experts at Mesa Labs are pleased to have helped California Dried Fruit in successfully completing the process validation…

FDA Form #483

What is a 483?

In the medical industry, you will hear that a company has been issued a 483 by the FDA. While most people are aware that this is a serious thing many may not understand what exactly this means. The FDA has the authority to visit a manufacturer to inspect their facility and verify that all processes…

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…

Specialty Pharmacy Solutions

Applying Specialty Pharmacy Regulations When Working with Partners or Contracted Organizations

Partner models consist of a healthcare institution operating a specialty pharmacy in partnership or in contract with another entity to offer the full range of services required for an accredited specialty pharmacy. Accreditation standards are a valuable resource to healthcare pharmacy leaders to ensure that all internal and partner specific regulatory components are in place.…