Data logger meets full FDA requirements

Signatrol is about to launch a high security version of its SL150 series of portable temperature datalogging tags which meets FDA requirements for electronic signatures.

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.

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

Routings can be complex with goods often being transhipped using several different methods and carriers.

Data loggers from Signatrol are already playing a vital role in this area by helping to monitor and record temperatures in applications as diverse as the shipping of star fruit from Malaysia to the transportation of blood products around the globe for the British Armed Forces.

The SL150 series of temperature loggers is specifically designed to travel directly with goods and provide a detailed date and time temperature profile which can be used to highlight any problems. The data loggers are housed in a fully weld sealed crevice free, robust food grade plastic tags only 10mm thick.

The tags use a patented induction technique for set up and data down load which means that there are no plugs, sockets or entries of any kind avoiding potential 'bug traps'.

Powered by an internal battery, the units can be selected to log at intervals from 30 seconds up to 100 hours and have a measurement range from -30C to +70C.

Now, in order to meet requirements from Signatrol's US customers and a growing number of UK pharmaceutical companies, the unit is being made available with special high security software ensuring it will have full compliance with the USA's Food and Drugs Agency FDA 21 CFR Part 11 legislation, including support for Electronic Signatures.

This is a federal regulation setting out the criteria under which the agency considers electronic records and, in particular, signatures and hand written signatures executed to electronic records, to be trustworthy, reliable and generally equivalent to paper records and hand written signatures executed on paper.

An electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted or authorised by an individual to be legally binding and equivalent to a hand written signature.

It must be unique to an individual and not reassigned.

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

The FDA rules currently define the standard for due diligence and the SL150-HS will provide users with important control features ahead of legislation.

There are several key elements of the regulation as follows; 1) The ability to discern invalid or altered records.

2) The ability to generate accurate and complete copies of records.

3) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

4) Limiting system access to authorised individuals.

5) Use of secure, computer generated, time stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

6) Use of authority checks to ensure that only authorised individuals can use the system.

Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: The printed name of the user.

The date and time when the signature was executed.

The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

Electronic signatures and hand written signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

Signatures should employ at least two distinct components such as an identification code and password, be used only by their genuine owners, and be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two more individuals.

The HS software implements all the features of 21 CFR Part 11, including the provisions for Electronic Signatures.

The software is split into two parts, the main section and a viewer.

The viewer is 'uncontrolled' and can run on any PC, enabling the operator to view current and 'old' data but preventing any changes to be made to the set up or the data. It also inhibits the archiving of any records which must be accompanied by an authorised electronic signature.

The main software permits access to all issuing, storing and reviewing functions but with tight controls.

When 'owners' purchase the software, they are required to register their ownership with the Signatrol web site by entering personal details, serial number of the software, the volume ID of the PC on which the software is to be run and a unique password which is required to implement future changes.

Each software package can only have one registered 'owner' and will only operate on one PC in order to preserve a contiguous audit trail. Registered owners are issued with a Security Access Code (SAC) so that they can enter (or remove) up to ten 'Registered Users'.

Note that it is a condition of 21 CRF Part 11 that the 'Registered Owner' cannot also be a 'Registered User'.

To register a new user, the owner enters their name, password and user ID.

When logging on for the first time, the user will be prompted to change their password to one of their own choice.

Registered users, by entering their unique password and user ID, have access to all the software functions and all records are time and date stamped and marked with the user's name.

Duplicate password and ID combinations are not allowed.

All records are stored in an encrypted form that cannot be altered by 'ordinary means' (ie by using readily available software packages) and can be archived for historical and security purposes.

An audit trail is also maintained on the PC which can be analysed as required.

In addition, the SL150 can be individually protected by a nine character ID code which is stored within the tag for life and is required to issue a tag or to change any of the option settings. There is little doubt that companies are becoming more reliant on electronic records and these offer significant advantages, not only eliminating mountains of paper work, but also speeding up data processing and information exchange.

However, in any system or process, computer related systems require stringent controls and Critical Control Points must be clearly identified which can be monitored through electronic audit trails.

This is onerous enough within the confines of any organisation but becomes ten times more complex once products or goods are transported externally.

As Brian Turner concludes: "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 SL150 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 SL 150 is just part of the company's extensive range of standard and bespoke data loggers and recorders.