Among the many regulations overseen by the Food and Drug Administration, there is one pertaining specifically to electronic records and signatures generated by computer systems - 21 CFR Part 11.  The FDA's purpose here is to ensure that electronic records and signatures are trustworthy, reliable and compatible with the FDA's mission of safeguarding public health.  Section 11.10 of the regulation requires procedures and controls to be put in place that "ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records".  Intelex offers a validation pack that is designed to test your system's compliance to these requirements. For more information, please contact an Intelex representative.

There are over 160 new enhancements in the forthcoming Intelex 5. Here are a few of my favourite new features associated with Document Control.

According to the Government Accountability Office (GAO), over half a million holders of U.S commercial driver's licenses also qualify for full federal disability payments due to health issues. Some suffer from ailments ranging from vision and hearing impairments to seizure disorders. The situation underscores recent calls on the Federal Motor Carrier Safety Administration (FMCSA) to bolster regulations governing the operation of commercial vehicles.

The FMCSA's primary mission is to reduce crashes, injuries, and fatalities involving large trucks and buses.  In carrying out this mandate, the FMCSA amongst other things, develops and enforces "data-driven&" regulations that balance motor carrier safety with industry efficiency.

Intelex offers a Department of Transportation (DOT) compliance module that was developed to enable operators of commercial vehicles to easily abide by FMCSA regulations.  The module stores driver information, tracks driver qualifications, generates real-time status reports, and sends automated escalating email reminders, and more.

10. Conservation of natural resources by minimization of paper usage.

9. Reduction of operational costs. Filing cabinets take up precious floor space which can be costly. Also, retrieving and processing paper-based documents is time intensive.

8. Increased productivity.

7. Ensure compliance with laws and regulations which require companies to implement document tracking procedures.

6. Backup of critical files.

5. Security. Prevent unauthorized alteration or destruction of data.

4. Accountability.  Provide audit trails as well as user logs and record activity.

3. Access control.  Control and designate access levels to an organization’s documents.

2. Process consistency. Enforce strict adherence to filing, naming conventions, and workflow processes.

1. Universal accessibility. A web-based document management system enables employees to retrieve documents wherever they are.

According to OSHA, July is the month with the highest occurrence of falls in the United States. This is probably due to the increase in construction activity during the summer months.

Brooks Schuelke of InjuryBoard.com discusses fall-related injuries in a recent post.  He covers various causes and highlights best practices to reduce incidences.

As of July 8, close to a thousand cases of salmonella poisoning have been reported in the United States and more than 130 people hospitalized throughout the country.  Safety officials are uncertain as to the cause of the outbreak. The initial focus was on tomatoes but jalapeno peppers, cilantro, and even some brands of salsa have also been cited as potential culprits.

The outbreak has brought attention to the role of the Food and Drug Administration in monitoring the nation's food supply. The FDA Commissioner is being called upon to use his emergency powers to put in place a detailed tracking system to follow produce from the farm to the dinner table. Meanwhile, the FDA's safety chief has urged corporate responsibility while lamenting that safety reports are still created using pen and paper.

The time has come for the agricultural sector to adopt widespread software tracking protocols in order to improve traceability. Some food producers already track their products. Most food producers place stickers on their fruits and vegetables. It might just be a question of adding additional information on the stickers to pinpoint where the produce originated and how it got to its ultimate destination. Every activity at every point in the supply chain needs to be captured electronically and stored in databases. This would make it a lot easier to create a clearer picture when safety issues arise.

An ideal situation would be similar to that of tracking parcels sent by couriers such as DHL or FedEx.  You enter a tracking number on a website and can immediately see the history of a product from its origin to its final destination.  This information should be made available not just to businesses and investigators but to the consumer as well.

Continuing the same theme as Lori's previous post, here is the list of the most frequently cited standards by the Occupational Safety & Health Administration for the last fiscal year.

1. Scaffolding (construction)

2. Fall protection (construction)

3. Hazard communication

4. Control of hazardous energy

5. Respiratory protection

6. Powered industrial trucks

7. Electrical, wiring methods, components and equipment

8. Ladders (construction)

9. Machines (general requirements)

10. Electrical systems design

During my first visit to Dallas I recall noticing a bumper sticker with the slogan "Don't Mess with Texas". I remember being amused and wondering what that was all about. It happens to be the name of the anti-highway litter campaign organized by the Texas Department of Transportation.  Over the years, the lone star state has championed several similar initiatives and is recognized as a national leader in environmental sustainability.

This week, the City of Dallas further boosted the state's reputation by achieving ISO 14001:2004 certification for its Environmental Management System.  EPA administrator Stephen Johnson commended the city for its commitment to reducing the impact of its activities on the environment. The city's EMS covers all 11 municipal departments and 13,000 employees. It is the widest implementation of an EMS in the country.  The city of Dallas was one of the first cities to purchase Intelex Environmental Management System software back in 2004 and is among a growing number of Intelex municipal clients.

The City of Kitchener's fleet operations which run its vehicles and related equipment recently garnered an ISO 14001 certification. An organization is deemed to be certified after an audit performed by an independent body confirms that its EMS is up to snuff. This is a way to let the world know that it fully conforms to the requirements specified in the ISO standards.

The City of Kitchener is the largest municipality in the Region of Waterloo. The Region of Waterloo has had a lasting relationship with Intelex dating back to 1998 when they chose ISOsoft for their first Environmental Management System.

Let's face it, the term environmental management system is not quite a household name - at least not yet. I've been interested in finding out whether more people have been consulting Google for anything related to "environmental management" ever since saving the planet became really fashionable so I did some research and have compiled the results in a chart. They reveal that while there has been an increase in queries for terms such as "green business" and "carbon footprint" the volume of searches for "environmental management" has not increased at all. In fact, it has declined steadily. Closer inspection of the chart shows that "carbon footprint" became a really hot search in late 2006. My guess for why this happened is media exposure. People tend to search for what they see or hear from the media. According to IMDB.com, the documentary, An Inconvenient Truth was released in August 2006. I'm pretty sure it's partly responsible for why people started inundating Google with searches for "carbon footprint". This begs the question: How does one get Al Gore to film a documentary about Environmental Management Systems?