Among the many regulations overseen by the Food and Drug Administration, there is the 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.

Written by Dan Marcus

It’s difficult to define a single number that each company can use to calculate the impact a management system will have on their bottom line. With that being said, there is transferable logic that every company can apply to calculate their return on investment by establishing better data management.
 
Managers are hired because of the unique knowledge they possess in their area of expertise (human resources, safety, environment, or quality management). A manager’s main objective is to implement changes that promote continual improvement. Investing in a data management system has a direct effect on an organization’s bottom line because it enables the organization to better utilize their key employees. A direct return is inevitable when the amount of time key staff spend managing data is reduced. This is especially true when preparing for audits.

Audit reporting involves thousands of records and can take managers and support staff weeks to prepare, in addition to their daily data management routines. Utilizing a direct-entry database significantly reduces the time and intellectual resources required to collect and format company data.

Once the necessary information is collected and formatted, reports need to be generated. The Intelex Management System simplifies the reporting process through configurable reporting functionality that enables users to create and store reports based on their specific corporate or auditing criteria.

With information being collected in real-time and reports being preconfigured for single click access, employees save countless hours that can be more effectively devoted to their primary objective; observing behaviors, analyzing data, and developing changes that further impact the bottom line ― reducing costs and increasing productivity.
 
Data management systems also generate secondary return-on-investments such as new opportunities for corporate marketing efforts and corporate recognition through industry awards and media acknowledgements, both generate increased business opportunities.
 
An organization’s bottom line is therefore improved by reducing the amount of time key employees spend managing data while providing a tool to aide in continual improvement. In an environment where transparency can make the difference, data management provides a basis to prove what you preach, which can make the difference between market share or the big contract.


Welcome to the new Intelex corporate website. Since 2000, Intelex has experienced tremendous growth in terms of product development, client base, and the number of Intelexians who have joined our team. To compliment these achievements, Intelex has updated its corporate image with a new stylized company logo and a sleeker more contemporary corporate website.

When we began the process of rebranding the Intelex image, there were two main objectives that we wanted the new corporate website to fulfill:

• Firstly, the new website needed to reflect Intelex’s growing corporate presence in the environmental, quality, health & safety and business performance management industries, and

• Secondly, we wanted the new site to represent the complete breadth and depth of the Intelex product line.

We believe that we’ve succeeded in meeting both of these objectives and welcome comments and suggestions from our clients, partners, and prospective clients.

On behalf of the entire Intelex Team, thank you for your support and we look forward to continuing to provide our clients with best-in-class performance management software and support.

A recent independent study conducted by the Aberdeen Group indicates that businesses using real-time performance reporting (like the reporting functionality included in the Intelex EQH&S Management Systems) realize greater success in relation to equipment effectiveness, production yield, and profit margins.

According to Matthew Littlefield, a senior researcher at Aberdeen Group, “best-in-class manufacturers are more than twice as likely as laggard manufacturers to monitor exceptions on the plan floor in real time, use real-time data in production optimization processes, and in using real-time data for the production release and control.” (Quality Digest, July 2008)

All of Intelex’s Modules come with real-time reporting functionality. The data in the Intelex System is viewable through graphical scorecards that are displayed on corporate dashboards for an instant 360 degree view of your business.  

Visit the  Aberdeen Group's website for the full report.

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

1. There is now an option to convert uploaded Microsoft Word and Excel documents to PDF. This new feature is backwards compatible so you can convert both .doc and.docx file formats.


2. The ability to assign reviewer and approver privileges to specific employees and workgroups.


3. Configurable security so administrators can assign access levels to system users.

4. Related documents are now displayed and hyperlinked.


Six new reports for clients using the Intelex Standard Nonconformances Module have been posted on the Intelex-Exchange (to be downloaded for free).

These reports have been designed to provide an instant, real-time snapshot of your organizations standard nonconformance and corrective/preventative actions performance.

Corrective/Preventative Actions by Report ID
Standard Nonconformances by Type
Standard Nonconformances by Classification
Corrective/Preventative Actions – Last 90 Days
Corrective/Preventative Actions – This Year vs. Last Year
Report ID – Stages by Date


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.


New reports and scorecards for the Intelex Audits Management Module are available to be downloaded for free from the Intelex-Exchange.

Once you’ve used the reports post a comment to let us know how they've made your job easier. Or post a comment with suggestions of reports or scorecards that you’d like to see built.


REPORTS

Audits Scheduled in Next 90 days

Lists all the audits that are scheduled for next 90 days.

Completed Audit Results

This report lists all the audits that have been completed in the last 3 months.

Upcoming Audits by Type
Grouped report listing all the audits upcoming for the current year.

Audits by Person Responsible

This report displays a list of Audits that are scheduled for the current year and grouped by Person Responsible.

Follow-Up Actions by Audits

Grouped report showing the Follow-Up Actions that are required after conducting the audits.

Scheduled Audits This Year by Month
Grouped report showing scheduled audits for the present year.

Upcoming Audits by Location
Groped report showing the upcoming audits grouped by location for the current year.

Audits Causing Standard Non-Conformances
Grouped report showing audits resulting in Standard Non-conformances.

Audit Scheduled This year by Type
Matrix report showing the number of audits scheduled this year by Audit Type.

Audits Completed This year by Type
Matrix report showing the number of completed Audits in current year by Audit Type.

Audits Scheduled vs Completed by Month and by Audit Types
Audits as well as Completed Audits for the current year by Audit Type.

SCORECARD
Number of Audits vs. Number of Follow-Up Actions
Graphical representation of the number of audits for the given year vs. number of follow -ups happening during the same year, grouped on a monthly basis.


It’s official, Intelex 5 is almost here! Intelex is excited to announce that our ASP clients will receive the release of Intelex 5 on Sunday August 17th with enterprise clients to follow shortly after.

With over 160 new features, enhancements and improvements, Intelex's Version 5 is a breakthrough in EQH&S and business performance management.    

SNEAK PEEK OF NEW FEATURES

-Message Centre - discussion & collaboration tools

-Automatic document to PDF conversions

-New dashboard layouts & design tools

-Printer-friendly dashboards

-Custom email templates

-"Email this page" functionality

-Automated document update notifications

-Enhanced control of dashboard security

-Enhanced merge fields in email templates

-Intelex web services & API

-New configurable Intelex homepage & module homepages

-Custom calendars with filters, highlights and multi-day events

-Centralized system setup and configuration

-Over 20 new and improved scorecard types

-21 CFR compliance and dual signatures

-Click-through capability on configurable reports

-Unlimited icons on toolbar with scrolling ability

-Notifications on training courses and document changes

-Custom formulas, calculation and script editor

-Click to view larger image.

 

Stay tuned for more updates about the release of Intelex 5.


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

2. 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.

3. Increased productivity.

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

5. Backup of critical files.

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

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

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

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

10. 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.

food safety trackingAs 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.

Attention Intelex document control users, five new document control reports are available to be downloaded for free from Intelex-Exchange.com. Remember that all of these reports can be added to your dashboard to give you instant, real-time document control data. Enjoy!



Ready for Release List

Lists all the documents that are finished being edited or being approved and are ready to be released. 

 

Rejected Document List

Lists the documents that have been rejected for the current year.

 

Change Request Overdue This year

Lists the documents whose change requests are overdue for the current year.

 

Rejected Change Request

Lists the documents whose change requests have been rejected and the reason for the rejection.

 

Pending Actions

Lists documents with pending actions, grouped by the status of the document for the current year.


The Lahore Development Authority (Pakistan) has announced that they will be implementing quality control laboratories to assess the quality of road materials and construction procedures being used across their developments.  To kick off this new quality management initiative, the LDA “has issued orders to all contractors enlisted with LDA … [the contractors] have also been instructed to ensure submission of road materials to such 'Quality Control Laboratories' so that material could be screened in accordance with international standards” (Nation.com 2008).

I’ve blogged about the value of a quality management system before but I thought this story exemplified the point that quality control really can be applied to any industry, product, and service.

To read the complete story about LDA’s quality control program visit www.Nation.com.

 


The past several months at Intelex have been nothing short of exciting.  As our client base continues to grow, milestones are quickly being reached.  The month of June saw Intelex reach its 300th client!

As a result of this positive growth, our staff at Intelex has also been expanding to help meet the positive trends we’re ecstatically experiencing.  Recent additions to our Marketing, Development, and Client Services teams are helping put Intelex in great position to meet (and hopefully surpass) every single one of our clients’ needs. 


To help add to this excitement, Client Relations would like to take the opportunity to invite our Intelex users to actively participate on our blog!  Along with providing useful and informative information to our clients about our industry, we feel that the blog is a great medium for clients to tell us about their particular successes using Intelex.  You can simply respond to a particular blog posting having caught your interest or attention, or you can email Client Relations at client.relations@intelex.com with specific details of what you wish to convey.  We would be more than happy to submit a post on your behalf and would be thrilled if you took an interest in helping us grow Intelex’s online community! 

At the end of the day, the Intelex blog is not only for our users, but about our users.  So whether you were client # 1 or client # 300, we would love to hear from you! 

Client Relations

Intelex Technologies


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





They say that one man’s success is another man’s failure.  While I personally find this kind of worldly insight a little cliché, this particular adage, if nothing else speaks volumes about how we define success.  I think we can all agree that although success can be measured in a multitude of acceptable albeit subjective ways, it doesn’t necessarily have a definitively right one.  Recently, I sat down with Senior Project Manager Kulbir Bal in hopes of hearing about a compelling client story I would be able share with our blog readers.  A modest Kulbir, refusing to play favorites, instead treated me to his unique and insightful perspective on what he believes accounts for a client’s success with Intelex. 

 

It was clear from our discussion that there were two fundamental elements that would lead any client to a successful implementation of the Intelex system:  relationships and planning.  While perhaps not an epiphany to anyone reading this, Kulbir believes that these elements can be easily overlooked.  I would tend to agree.  While learning the nuts and bolts of a new system is important, Kulbir suggested that participating in training for a number of days is only, “one stop during the implementation road.”  Getting full value out of the Intelex system or any other new software for that matter can only happen once concrete relationships have been formed between Project Managers/Consultants and the clients they work with.  Only once levels of trust are achieved from “getting to know clients at a personable level and putting their minds at ease,” can appropriate planning and objective setting ensue.


Perhaps the most important point Kulbir drove home was the need for new clients to identify one or several individuals within their company or organization who would champion the Intelex system, assuming ownership of the software, creating excitement about it while acting as an internal coordinator.  He suggested that, “most clients are as successful as their preparation goes.  If they’re ready and have all necessary processes in place and caution off some time to work with the system, success will quickly follow.”  If you haven’t done so already however, fear not! An Intelex Project Manager or Consultant can help you identify who these individuals could potentially be and would be more than happy to help set appropriate planning in motion. 

 

So there you have it!  Your success with Intelex really isn’t a big secret.  As Kulbir pointed out, it really boils down to intelligent planning and strong relationships.  It’s a simple recipe, but one with a proven track record. 


An increase in workplace fatalities, like the untimely deaths of a crane operator and construction worker in New York’s lower-east side (May 2008), reinforces the desperate need for workplace safety programs.

With thousands of people needlessly dying on the job every year, one can’t help but wonder what’s going wrong.  According to Michael Belzer, associate research scientist with the Institute of Labor and Industrial Relations at the University of Michigan, one factor may be that “… in an economic downturn there’s more pressure on people to get more done for less time and less money.”  (MSNBC 2008)

Following that logic, for a corporation to implement a Safety Management System it will cost money, but the price tag is miniscule when compared with benefits of having a healthy workforce. Ultimately, the money an organization saves as a result of fewer production days lost to sick leave, significantly reduced liability expenses, and an increase in employee satisfaction far outweighs the cost of the initial Safety Management Program.

So as I see it, the necessary steps to increase employee health and safety are three-fold. First, corporations need to take a proactive approach to protecting the welfare of their employees by investing in a Health and Safety Management Program. Secondly, the government needs to effectively enforce healthy and safety regulations. And lastly, employees need to demand safe working environments.


Alexander Gordon makes a great point in his article [The] Importance of Document Management in Compliance Strategies when he says “Compliance strategies help decrease regulatory as well as litigation risks that the enterprise faces. They help to reduce mismanagement of data, ensuring that the companies secure their information and utilize it wisely.”

Gordon’s full article is really useful in explaining the value of a document control system, but this particular quote stands out because it speaks to one of the core values of a well-designed document management system ― the ability to help ensure internal and external regulatory compliance.

Industry executives understand that having document control procedures in place improves workflow efficiency, which in turn saves money by eliminating the duplication of employee efforts. But what they often overlook is the value that a simple document management system can offer from a risk prevention perspective.

In 2008, there isn’t an industry out there that doesn’t have to meet some sort of regulations or risk being penalized. By implementing a document management system corporations can ensure compliance through corporate-wide workflow procedures and real-time status reports.


Another successful Webinar!  I just finished conducting the Take a Tour of the Back Roads Webinar and it was well received.  This webinar was free and designed to give clients insight to the many consulting tips I’ve gathered over the years.  Whether new or veteran clients – they learned great ways to make the Intelex system in their organization, a success!  We covered the following topics:

Configuration:

-         Configurable Security

-         Toolbars

-         Effective Email Notifications

Efficiency Tools:

-         Data Copy Function

-         Importing Tools Available…and are you using all fields?

Beneficial Features:

-         Benefits of the Reporting Suite

-         How iForms can help

-         Configuration Services Available

Module Specific:

-         Making Accessing Documents Even Easier

-         Making the best use of Training Work Groups and Grace Period

Followed by an open Question and Answer period where many good questions came up.