Control solution guarantees 21CFR11 compliance

AJM Automation has come up with an "out of the box" 21CFR11 compliant package for ensuring traceability through food and pharmaceutical production.

A new way of ensuring traceability through food and pharmaceutical production is needed, otherwise prices could soar as new legislative demands continue to add cost to the manufacturing processes.

Increasingly stringent traceability standards are now required through FDA (Food and Drug Administration) Regulation 21CFR11.

Although the FDA is an American body, 21CFR11 is required, followed or forms the basis of much local legislation around the world, including Europe.

This security is required because there is always the possibility of errors during manufacture or packaging.

There are also increasingly frequent cases of products deliberately being corrupted with the intention of besmirching a company's reputation or extorting money from them.

In mid-September 2001, for example, an already-traumatised American was terrorised by the malicious distribution of an alleged anthrax virus.

Although this proved to be a hoax, it had to be treated very seriously by the security services.

Had there been bombproof traceability in all production facilities, the level of alert could have been contained at a far lower level.

To date security of production has relied on logging of all actions by staff.

But this is time consuming, very expensive and open to easy fraud.

So AJM Automation in Derbyshire has come up with a new approach: an "Out of the box" 21CFR11 compliant package.

This secures the control system from everyone except registered operators, and only permits them access once they have been identified by biometric confirmation, ie digital fingerprint recognition.

AJM is the UK distributor of the PowerStation touchscreen machine monitors or HMIs made by CTC Parker Hannifin Automation in the USA.

It has customised the PX15 PowerStation so that it can run with CTC's InteractX control systems and, for biometric security, DataTrak software from Ultima Control Systems' in Leicester.

Ultima is also an approved system integrator for InteractX and is working closely with AJM on the project.

The design is based on the standard PX15 PowerStation workstation, but is presented with a stainless steel front bezel to meet hygiene standards for food, pharmaceutical, petrochem and other demanding environments.

The fingerprint recognition system is built into the front for ease of access and use.

There is scope for dual authentication procedures, eg fingerprint and PIN or password.

"To use the workstation an operator must place his finger on the identification pad, where a digital code is instantly created which represents the complete and unique fingerprint".

"This is compared with codes in the electronic memory and if a match is found access is provided to the control system", explains Andy Markgraf of AJM.

"If no match is found, access is denied and an alarm protocol can also be enacted".

Accepted fingerprints need not give everybody full access.

Because prints are unique, people can easily be classified in to one of several levels of access, from local monitoring, through some capacity to make changes, to full control.

PowerStations are high performance yet easy to use touch screen HMIs (human machine interface).

The product family offers a range of workstations from a small simple display to a full capability PC with 18in touch screen.

They come bundled with Interact or InteractX software, the former being for simpler duties, the latter offering advanced features and functions normally associated with high-cost Scada and similar programs.

Their modular construction allows specification to precisely match exact application needs and minimise system overhead, while a removable Flash memory simplifies data storage, information transfer and programme updates.

Interact and InteractX provide advanced HMI graphics, but their modular architecture removes all the systems redundancy normally associated with Windows based-systems so that speed and reliability are secure while system integration costs are contained.

The biometric system is based on Ultima Control Systems' DataTrak software, which provides 21 CFR Part 11 compliant interface.

The latest Win32 version of DataTrak is designed around Authentec's USB fingerprint sensor, and uses their recognition engine.

DataTrak can now operate in three distinct modes.

In "standard" mode the system simply requires username and password.

In "biometric identify" mode an operator needs to place their registered finger on the sensor and DataTrak will identify them and allow them access to the operation they requested.

In "biometric confirmation" mode the operator places their finger on the sensor; DataTrak identifies them and then prompts them for their password.

DataTrak can be used under Visual C++, Visual Basic or VBA.

It takes care of all the basic functionality requirements of 21CFR11 including operator logon, local security policies, audit trails, batch reports and event logs.

Users can be allocated up to four security levels (operator, supervisor, engineer and administrator) and local security policies include password length, password expiration, logon expiration, user lockout etc.

For validation, audit trails, event logs, alarm logs, test logs, batch reports etc can be stored in local or networked files and/or in a SQL2000 or Oracle database.

Report printing, archive and restore functionality, screen configuration etc are all built in features.

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