The Evolution of EH&S Compliance and Operational Risk Management Software

Compliance Management and Operational Risk SoftwareBioPharma EH&S Podcast Episode #11

In Today’s Episode:

  • Review of Episode 10
  • Discuss: The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software
  • Upcoming Events and Happenings of Importance to EHS professionals in the BioPharma industry.

Hello everybody and welcome back to the Biopharma EH&S Podcast, Episode #11, it’s Saturday, February 26th, 2011.  And this is the podcast helping you take your environmental, health and safety program to the next level.

I hope everyone is doing well today, and first off I would like to say that I realize that we’re doing today’s podcast a little early this week, but that’s because I have an extremely busy schedule this upcoming week. This next week, on Tuesday, I will be heading to San Antonio, Texas for the National Association for Environmental Management (NAEM) Management Information Systems conference which will be happening on Wednesday and Thursday, and then on Thursday of the following week I will be heading to Austin, Texas for South by Southwest.  I will talk more about both of those events towards the end of today’s podcast.

But, as always, the first thing I’d like to go over is to let you know what is on the agenda for today. So the first thing, the first thing that we always go over is to review what we talked about in the last episode, then we will cover our main topic for today, which is “The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software“.  I thought with the NAEM-MIS Conference coming up next week that this would be appropriate.  Then after that we will discuss important events and happenings of importance to EH&S professionals in the biotechnology, pharmaceutical, and medical device industry.

As a podcaster, having listener questions and feedback is extremely important and it would me a lot to me. So, please call our listener voicemail feedback line at 206-337-4769 with your questions regarding environmental health and safety software, potent compound safety, industrial hygiene, and anything else related to EH&S in the Biopharma Industry.

O.k. with that out of the way, what did we discuss last time.  In Episode #10 we discussed “Industrial Hygiene in the Pharmaceutical Industry.” In that discussion we talked about the strategies for managing a potent compound safety program in the pharmaceutical industry is actually similar to managing a traditional industrial hygiene program, however, the big difference is that many of the compounds have occupational exposure limits that are significantly lower than those of traditional industrial chemicals, and that you will have to place an emphasis on engineering controls in order to achieve acceptable airborne concentrations.  If any of that sounds interesting to you, please go back to Episode 10 and listen to the whole thing.  If you still have questions, please contact us at Affygility Solutions.

So, let’s go ahead and move into our main topic for today, which is:

The Evolution of EH&S Compliance and Operational Risk Management Software

So what exactly is EH&S Compliance and Operational Risk Management Software?  Well that can mean many things to many different people and companies.  For some companies that are somewhat in the reactive mode – it may mean just tracking occupational injuries, accidents, and claims.  For others, for those companies that are slightly more proactice – it may mean audit finding tracking, corrective action tracking, and leading indicator tracking.  And for the more advance companies it can mean tracking sustainability efforts, and greenhouse gas reduction efforts.  It also can mean authoring and managing material safety data sheets, air emissions reporting, hazardous wastes management generation tracking, industrial hygiene data management, and many, many other environmental, health and safety program elements.  Part of the challenge that I see today, is that there are a lot of systems that are out there that are trying to do EVERYTHING – thus making it difficult for companies to get their arms around such a system.

So, let’s step back for a moment and talk a little about the history of environmental, health and safety compliance software, and operational risk management software.  Back in the mid-1980’s when I started in the field I was working for Waste Management of North America as an Environmental Coordinator.  Back in those days I remember that the majority of EH&S tasks were done by paper, and completion of paper-based forms. I also recall that EH&S professionals were largely the people with the big binders on their bookshelves containing all the company EH&S rules and programs.  At that time, at least at the entry level, personal computers in the workplace were rare.  Then as we approached the 1990’s a few computers starting appearing around the office, but were pretty much exclusively limited to divisional presidents, directors, and an administrative assistant or two.  I still recall, looking out my office door, and seeing our library of federal and local regulations that covered the entire wall in one of our common areas.  Then in the late 1980’s, our first safety management software system appear.  It was a DOS based system used for reporting occupational injuries, accidents, and other claims. It was basically, a workers’ compensation and liability claims management system.  So, it was really an operational risk management software tool.  Still at that point, data entry into the system was primarily done by the admins, and the EH&S management would receive a printed report once per month.  As more and more people in the office begin to have dedicated computers, everyone started  to get creative in using them to manage various issues, including EH&S.  I believe the first EH&S software tool that I every developed was a Lotus 1-2-3 spreadsheet used to track employee training.

Then in 1990, the next environmental, health and safety management software tool that I recall using was a system called CMS, which stood for Compliance Management System, and as the name refers to, it was primarily a PC-based system to manage EH&S compliance tasks and requirements.  It was ugly, but it actually worked quite well.  The one challenge however, was in those days, implementation was a pain.  A team of people would come out for a week or more, review every permit, every requirement and input them by hand into the environmental, health and safety software system.

Then around 1993, I recall my first experience with the world wide web – I clearly remember that I was in the office of the IT manager who’s office was next to mine, and using Mosaic we pulled up the Center for Disease Controls’ website.  I remember thinking to myself – this is cool – this is really cool.  At that time, little did we know, what were where about to experience over the next decade.

After that event, I remember that information technology the environmental, health and safety field just exploded, and in March of 1993, I attended the Global Environmental Management Initiative meeting in Pentagon City, near the Washington, D.C. area.  During that meeting, there was a presentation about integrating right-to-know information at Dupont.  It was basically centered around managing material safety data sheets.  During that same time frame, I recall seeing a presentation by Bill Sugar on Anheuser-Busch’s Environmental Management System, which was originally written in Lotus Notes.  It had it’s shortcomings, but with the leadership of Bill Sugar and his team of environmental, health and safety professionals they took EH&S management to a whole new level.  We then began to see environmental, health and safety software move from compliance-focused, and regulatory reporting focused to more of a total quality management approach.  With the emergence of ISO14001 and OHSAS 18001 managing data began more important.  In addition, with increase demand for corporate transparency, the need for rapid access to environmental, health and safety data became even more important.

So, that’s some of the early history of environmental, health and safety software.  And were do we stand today?  Well, that vast majority of environmental, health and safety management systems are web-based.  Everyone has an email, everyone has access to a computer. Our cell phone’s have more computing power than my first computer.  Most major corporations collect and report all kinds of environmental, health and safety data.  The majority of this data is readily available to anyone with a computer.

So what challenges do we face today?  First off, reducing complexity.  As a provider of environmental health and safety software, we have to realize that not every company is going to have a full-time administrator to run these complicated systems.  More features, doesn’t necessarily mean better.  Forget “kitchen sinkness” or “feature creep” which is where software developers think they have to add every single possible feature to the system.  In most cases it only increases the complexity of the program without adding additional benefit.  If you think about it, the one reason text messaging and twitter is so popular is that if you can’t say it in 140 characters then you’re saying too much.  Second, there’s too many companies offering EHS software solutions out there, there has to be, and will be some industry consolidation.

So, what’s in store for the future of environmental, health and safety software?  Well, EH&S mobile apps, like Affytrac mobile will become more important.  I also have addditional thoughts, but prefer to keep those to myself for now.  But I promise you, the next 10 years will be an exciting time for everyone.

Oh By the Way, does anyone have a AOL floppy disk I can borrow?

Alright, so that does it for our discussion on “The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software”

So here’s events and happening for environmental, health and safety professionals.

Next week, as previously mentioned, in San Antonio, Texas – the National Association for Environmental Management will be having its Management Information System conference.  I’ll be there and would love to meet you.  Please call me at 303-884-3028 or email me at

Next on March 6-10, it’s the Society of Toxicology‘s annual conference in Washington, DC.  I won’t be there, but Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions will.  If you would like to talk to Joe, please give me a call and I can arrange it.

Then in April, Affygility Solutions has a whole bunch of environmental, health and safety webinars starting.  These include, our every popular Advanced Topics in Potent Compound Safety, our Dermal Exposure and Absorption of Active Pharmaceutical Ingredients, Isoflurane Safety, and much more.  Go to and check out our schedule

Well, there are other conferences coming up, but we’re out of time.  Remember you can follow us on twitter at, stalk us on Facebook by searching for Affygility Solutions and giving us a “Like”, on LinkedIn you can search for Affygility Solutions and give us a follow, and finally you can subscribe to our free Biopharma EHS podcast on iTunes by simply searching for it.

That does it for this week’s show, have a great week and I hope to report back next week on how the conference in San Antonio went.


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

Affygility Solutions - provider of potent compound safety, webinars, and compliance management software