Using Digital Data Loggers?

Vaccines for Children (VFC) and Temperature Monitoring Equipment

Are you using digital data loggers? How about household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans,…

Vaccines for Children

Vaccines for Children (VFC) & Vaccine Storage

Are you using household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans, Temperature Monitoring Equipment, Best Practices…

Friday Facts - Monitoring & Measurement of Processes

Monitoring & Measurement of Processes

A manufacturing company is required to have suitable methods in place for monitoring and measuring the processes involved in their quality management system.  According to ISO 9001, “These methods shall demonstrate the ability of the processes to achieve planned results.”  Essentially, what this requirement is asking you to do is to confirm that you’re having…

CVS site

Mesa Labs Compliance and Validation Services

Mesa Labs announces Compliance and Validation Services by launching a redesigned website to better highlight the areas where Mesa services can offer the most benefit. Having been a manufacturer of monitoring and validation equipment for decades, Mesa is uniquely suited to offer calibration and validation services as well as being ideally positioned to help its customers maintain compliance.

complaint box

Complaint Files

A requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files.  According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is…

Handling, Storage, Distribution

Handling, Storage and Distribution

Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product.  21 CFR 820 breaks down the requirements for each of these processes.  A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product.  These…