High-security logging tags aid FDA compliance

Signatrol has developed a high-security version of its SL150 series of portable temperature data logging tags.

Signatrol has developed a high-security version of its SL150 series of portable temperature data logging tags.

The new SL150T/HS and SL151T/HS in-transit data loggers are special high security loggers designed to operate with the company's Tempit-HS software on a single PC and to provide irrefutable records, electronically signed, of the temperatures encountered throughout the transportation and storage phases of sensitive cargoes.

When used with appropriate operating procedures, the system provides records, audit trails and supports electronic signatures in accordance with FDA 21 CFR Part 11 regulations.

It is also ideally suited to other applications where Due Diligence and HACCP are essential parts of the manufacturing and distribution of products especially in the food, medical and pharmaceutical industries.

Temperature control is one of the most critical factors in maintaining the quality of food, pharmaceuticals and blood products, especially during transportation.

Routings can be complex and the tags are ideal for multiple journey routines where products are transported in several stages and by different modes of transport and carriers.

With heightened awareness of issues relating to the safety and quality of goods such as food and drugs, increased legislation is leading to the implementation of new procedures and controls for storage and transportation.

However, the effectiveness of any controls can only be as good as the equipment, procedures and, above all, diligence of the personnel involved at each and every stage.

Unfortunately, as equipment and systems become more sophisticated, the opportunity for error or fraudulent misuse increases and therefore unambiguous and strict product traceability systems are vital with electronic records playing an increasingly important role.

The SL150 series of temperature loggers are specifically designed to travel directly with goods and provide a detailed date and time temperature profile that can be used to highlight any problems.

The data loggers are housed in a fully weld sealed crevice free, robust food grade polystyrene tags only 10mm thick.

The tags use a patented induction technique for set up and data down load.

As result there are no plugs, sockets or entries of any kind thereby avoiding potential 'bug traps' and ensuring total sealing.

Powered by an internal battery, the units can be selected to log at intervals from 30s up to 100h and have a measurement range from -30 to +60C.

With an internal capacity of 16,000 readings, the unit can keep recording for more than four years.

The "delayed start" feature can be set to coincide with the start of a particular travel schedule.

The Tempit software system has four rigidly controlled access levels, from the primary administrator going down through to secondary administrator(s), user(s) and auditor(s).

Once registered, the primary administrator is issued with master passwords, allowing that person to set up and manage all the system parameters.

They can also manage secondary administrators, users and auditors, with full access to history files and reports.

Secondary administrators can manage users and have access to history files and reports.

Users have limited access allowing them to issue tags and save data.

Auditors have time-limited access to all records and history logs.

The comprehensive Tempit software provides full traceability of all "reads" and "issues" as well as printing on the graph the identity of the person or persons responsible for specific data over a given period.

It also provides secure, irrefutable and encrypted records which can be displayed in easy to read graphs or data tables.

It manages passwords including time-out periods and forces periodic password changes.

When passwords are issued, recipients accessing the system for the first time are prompted to change their password to a unique identity known only to themselves.

The system ensures true and unalterable chronology of events and records whilst also annunciating and recording time and temperature alarms.

It also controls archiving of data to auxiliary computer drives and enables the emailing of graphs to remote sites.

The built in powerful search facility allows the speedy access to specific data with keywords including user name, date and transport manifest details.

The software manages calibration, flagging up if tags are out or about to go out of calibration.

It also provides an audit trail to assist auditors who by default are granted 48-hour access.

Although the FDA regulation has no official status in Europe, Brian Turner, MD of Signatrol, believes that similar regulatory control is not far away.

As he concludes: "The FDA rules currently define the standard for due diligence and the Tempit-HS will provide users with important control features ahead of legislation.

Setting up any electronics record system is only the start and companies must ensure consistent processes and procedures are implemented to maintain an effective level of security and control.

Although products like our high security logging tags may appear to have only a tiny part to play in any process, they provide a vital continuity link in an important area".

Signatrol is the dedicated data logging division of Status Instruments and the SL150 series is just part of the company's extensive range of standard and bespoke data loggers and recorders.

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