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New Year, New Rules

As we begin 2015 lots of you will be putting together plans for the year ahead and perhaps looking at what up-coming legislation changes could be affecting you. A range of new guidelines come into play this year for a number of industries and temperature control plays a key part in ensuring effective compliance.

One example is in the US where the Food and Drug Administration (FDA) is using the Food Safety Modernization Act to tighten up the food supply chain meaning impacts for the food and beverage industry. Another is in the EU where the European Parliament is looking to bring out further controls and clarification on the Good Distribution Practice (GDP) of medicinal products for human use ­– a ‘watch this space’ for the medical industry.

A common aim of these regulations is to ensure organisations are obliged to demonstrate their product’s integrity which includes uses measures such as tamper proof records and the traceability of temperature controls. The GDP states

“Documentation [as defined by all written procedures, instructions, contracts, records and data, in paper or in electronic form] should be approved, signed and dated by appropriate authorised persons, as required. It should not be hand-written; although, where it is necessary, sufficient space should be provided for such entries.”[1]

Hence companies are now turning to automated, computerised methods such as the FilesThruTheAir™ system.

Using FilesThruTheAir™, organisations can easily set up specialist sensors which then send automatic temperature measurements seamlessly to its Cloud platform. The Cloud allows you to log in securely, view all sensor data and set up alarms and email notifications should specified temperature limits be reached. The data recorded cannot be tampered with and there is the facility to add notes to any event such as a temperature alarm. These notes and any changes to settings are added to a log with the users ID and a time stamp, so you have complete visibility of your monitored environment – an auditor’s dream!

To hear more about how the FilesThruTheAir™ system can help your company achieve compliance on temperature control legislation please contact our sales team on +44 (0) 1425 651111 or email sales@filesthrutheair.com.

Jessica Regan, Sales Coordinator – Corintech Ltd

[1] European Commission guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use, section 4.2.


Created on 15/01/2015