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Taking Another Look At Automated vs. Manual Compliance

Time to take another look at automating FDA compliance?

“Gosh”, you say, “need we or any pharmaceutical manufacturer look any further than the mountains of forms we fill out hourly in order to get an order out the door?”

YES, it’s time to take another look at compliance because the FDA’s swelling ranks give you new reason to do so. This means even more FDA inspectors fully schooled in regulations of 21 CFR Part 11 that pharmaceutical firms must live or die by. In our post 9/11 reality, you would be in your rights to suspect that these ranks will swell even more in years to come because, like it or not, public security demands that this be so. However, the BIGGER reason why you should revisit this now is that there are a growing number of systems out there that will allow FDA compliance for fast-growing firms, and finding right-sized solutions can be THE KEY to profitability.

FDA regulations do not require you to automate your business systems, and you will never find an FDA regulator who will tell you to do so. But if you make a frank comparison of man vs. machine, you can see why any FDA regulator worth their pay breathes a sigh of relief when they monitor pharmaceutical manufacturers that use widely recognized and standardized integrated business systems known to be adapted for FDA 21 CFR Part 11 compliance. Pharmaceutical manufacturers that use such integrated business systems can be expected to be a long way down the road of compliance. An otherwise comparable pharmaceutical manufacturer that uses entirely manual processes and handwritten records is quite a bit more suspect.

Unlike you or me, an automated system will do a programmed task exactly the same way every time. Humans have moods; machines do not. Humans are subject to sleep deprivation, attention lapses, bad attitudes and bad days. Good ‘ol automated systems just plug away the same way each and every time. While a very human production supervisor working in the context of a paper-based system might forget to consult the proper logs of quarantined materials, a properly programmed computer will never make that mistake and never prompt an operator to skip required steps for quality control and authorized signatures. No system that involves human action is bullet-proof, but automated systems can reduce risks of sloppy practices considerably. On the other hand, machines might fail miserably at finding creative solutions to new situations, and to the extent that compliance hinges on skills to handle exceptional situations, human hands and minds come to play a part.

It’s the FDA’s job to keep an eye on how much of a risk your business poses to the public. In turn, it’s your job (along with all members of your company’s executive team) to determine the limits of regulatory risk your company can handle. Regulatory risk is the risk of being found out of compliance. The financial risk of non-compliance includes costs of additional inspections, lost production time, unsellable product, recalls, plant shut downs, company fines, jail time for executives, and/or public relations fiascoes that put you out of business.

On the other side of the equation are the costs for compliance. In a totally manual system those costs usually involve added head count, along with all the salary and benefits such staffing requires. Automated systems not only have upfront costs for software (and sometimes hardware) but also for training, and validation of the systems. Sometimes automated systems themselves bring on added costs for IT expertise, and ongoing costs to ensure that the systems are updated and in synch with evolving Standard Operating Procedures.

Because information systems can lower people costs but generate their own costs, there has to be a balance to create the right level of automation at an appropriate cost. The type of products that your company manufactures and the processes that it takes to do so have a right-sized mix of manual and automated systems that will rely on computers for repetitive operations and humans for handling exceptions. Moreover, the size of your company is one of the best indicators of the degree of automated compliance that will pay off for your firm.

The largest pharmaceutical manufacturers that have numerous plants spanning several continents and many product lines, are the only types of companies likely to benefit from full (or nearly 100%) automation for compliance. Such large companies need centralized control and standard procedures to leverage their size advantage and lower the overall compliance costs (and risk!) on a per plant basis.

The smallest start-up pharmaceutical manufacturers that still have one foot in the research lab from which they spawned, are right to have sticker shock when they consider the integrated business systems the behemoth-sized pharmaceutical firms employ. But where many of these companies get into trouble is in not re-visiting the equation as their company grows.

First of all, integrated business systems vary widely in cost, with the ones geared for the largest companies in need of near total automation cost as much as 5 times what a comparable system geared for a mid-sized company would need. Secondly, the costs of compliance and costs of non-compliance are only a fraction of value created by integrated business systems. Within or without the pharmaceutical industry integrated business systems pay for themselves by helping cut the costs of production and doing business, e.g. by speeding product cycle time, cutting inventory costs, and more. Third, the disorganization potential of paper-based business systems is far more dangerous to a rapidly growing company. If you feel that you are already awash in paper, you may well be one of those companies that is so consumed in managing paper trails that you cease to see how crippled your operation is. And finally, a host of 3rd parties that can be critical to a mid-sized pharmaceutical firm’s continued success - from FDA inspectors, to Venture Capital sources, to banking institutions, etc.-will look positively on pharmaceutical firms with business systems on par with their scientific expertise.

Lots More Than Lot Tracking! - What FDA 21 CFR Part 11 Is and Is NOT

Since we're up in Toronto this week attending Microsoft's Worldwide Partner Conference, we thought we'd repost an article from our archives. This article was originally written by Merit Solutions' President Bill Burke, and was published by Pharmaceutical Processing in March of 2004. It's an oldie (but goodie) - Enjoy!

"Think that because you have strong controls for lot tracking and traceability you are fully compliant with FDA CFR 21 Part 11?

Think again! The truth is, lot tracking is more tangential to what FDA CFR Part 11 is all about, and far from being the pith of the matter. Yes, you must address lot tracking to be FDA-compliant, because lot tracking with integrity is an essential part of FDA-mandated GMPs (Good Manufacturing Practices). But lot tracking and other ingredients of product accountability are NOT what FDA CFR Part 11 is about. Rather, Part 11 addresses the closely related but separate matter of your data accountability.

"Data accountability--- huh????" you ask. "What's that?" Okay, let's consider the nightmare scenario that someone over at the FDA is probably already thinking about for another industry, and how 21 CFR Part 11 would look for them. Imagine a day when incidences of so-called mad cow disease become widely prevalent such that tight controls along the lines of FDA CFR 21 Part 11 are seen as necessary.

If that horrid day arrives and you, the farmer, unwittingly think that FDA CFR 21 Part 11 is just about lot tracking, you would dutifully put tracking numbers on every cow (just as they do in Canada) and mistakenly feel comfortable that your operation is fully compliant with FDA CFR 21 Part 11. This would be a very important step-i.e. numbering all cows in the herd. However, data accountability would mean that you not only can trace herd numbers, but also you have a complete historic record of where each animal ate, what it ate, where this food came from, when the animal ate it, who fed the cow, what the cow weighed before and after it was fed, where it slept, any exposures to cows in other lots, etc. You, the farmer, would not only need to keep this data, but you would probably need the equivalent of a dual password on a computer screen to get access to cows in a particular pen, and certainly would need such password protection before you were able to gain access to move cows out of a pen. Each and every time you or any and every farmhand did something with the cow, you would need to record it or track it, such that there is a complete data record of every cow's lifetime for every cow in the herd.

If you think that sounds potentially complicated, you couldn't be more right. And that is probably one reason why the FDA has NOT run to demand FDA CFR 21 Part 11 compliance to minimize the already miniscule incidence of Bovine Spongiform Encephalopathy. However, the FDA DOES demand that this type of life cycle data be recorded in great detail for pharmaceuticals. In fact, if you haven't invested in electronic systems that are known to be fully compliant with FDA CFR 21 Part 11, you might need to spend as much as $500,000 to write custom tracking automation software that brings you in reach of compliance on top of whatever pretty penny you have already spent to put in non-FDA compliant systems. Luckily, there are workable systems that are fully-FDA CFR 21 Part 11 compliant that do not come with that kind of price tag, especially if you are a mid-sized firm.

What FDA CFR 21 Part 11 is about, is the reliability and auditability of your electronic systems en toto. Even before the post-9/11 consciousness of how terrorists might try to wreak havoc, the FDA's regulations had the wherewithal to demand that data integrity be airtight. Let's take a look at some of the specific requirements and what this means for you and every pharmaceutical manufacturer.

Section 11.10 c, for instance, mandates "Protection of records to enable their accurate and ready retrieval throughout the records retention period." That means that your business systems need to capture all transactions, including updates and changes, and archive them in an accessible database that can be viewed, printed, exported and/or downloaded throughout the records retention period. "Ready retrieval" doesn't mean you can let your IT staff come up with some sort of procedure if and when the FDA requests data-it means you need to have this information accessible in keystrokes right away if and when it is required AND that this data is not changeable by happenstance.

Section 11.30 c, for example, stipulates that "loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls." This means that your manufacturing systems need to automatically disable a user account in the event of password loss or theft to protect data security.

Thus, in these as with all other details, FDA CFR 21 Part 11 is about data accountability. You either have it or you don't.

Sad to say, far too many pharmaceutical manufacturers seem to not only not be FDA CFR 21 Part 11 compliant, but to fail to even grasp what having it would require. Consider the firm that invests in ERP systems widely used in other industries, without considering if FDA compliance has been either built-in to the system or available as add-ons. And consider the potential that those with malevolent intent have to ravage the integrity of data essential to the profitable operations of your business. However carefully you consider this problem, know that the FDA already has, and the sum of their concerns is called FDA CFR 21 Part 11."

Learn more about MAXLife, Merit Solutions' pharmaceutical software for 21 CFR Part 11 compliance.

Renewal by Design: Building Your Business for the Emerging Economic Environment

One great joy of our business is being able to observe many successful teams of people across our clients, and to see how they react to market situations. As a manager, I feel like I am watching many sports games simultaneously, with our own players able to extend our client’s teams for important positions, but always within the strategy of those business leaders. This is true across industry, company size and geography in our client base. The past twenty four months have proven a huge contest, and we have seen some amazing examples of good management and innovation. But what interests me most now, as signs of an emerging economic environment appear, are the ways our clients are building themselves back up. In many cases, because of the experiences of this economic reset, our clients will be more successful than if the reset had not occurred.

I call it the Lance Armstrong syndrome. Most people know that Lance Armstrong won seven Tour De France victories, and most know that he battled serious cancer, but most do not know that he did not win the Tour De France until after he fought for his life against the cancer. He was certainly a professional cyclist prior to the illness, but unremarkable by most accounts. It is easy to see that the experience created mental toughness and drive. But what most do not know is that the experience actually physically changed his body, and that he essentially recreated himself into a different body type on purpose. The diseased ravaged his muscles to the bone. By his own accounts, he was so weak when he got back on a training routine he actually had to walk his bike up certain hills in the Austin, Texas area. Prior to the cancer, Lance Armstrong had a wider and stronger upper body that came from his earlier life experience as a swimmer and triathlete. This added weight and wind resistance. After the cancer, his body was purpose-built to very narrow upper body, incredibly powerful legs, base and core, and a substantially lower body fat ratio than he ever was able to achieve before.

I can draw a similar view of many of our clients. Some fought for their lives as a going concern. Some were early movers on hard decisions and gave themselves airspace, while some came dangerously close to the ground. But there is a sense of mental business toughness now among leaders and teams that could only be born out of necessity over the last several years. In a physical sense, clients are combining new ways of operating, and new ways of leveraging information, to essentially build their own organizations in a leaner, faster, more aero mode. They are using collaboration spaces, discussion threads and self service web portals for knowledge sharing to do more, faster, with less people. They have put in new processes and relationship management systems and customer feedback mechanisms to get closer to their customers. They have had to surface information in real-time modes, accessible by web and with devices, in order to make survival decisions. Now those web based information environments will enable them to beat competition and take market share. They have shortened their cash cycle through billing process improvements and customer management improvements. Now they have the discipline and systems to better manage their cash and reduce their risk exposure. Where there were gaps in efficiency, and loose processes that may have been just accepted in the past, they have had to be challenged and tightened during the last two years. Our clients are leaner, smarter, and ready to compete in ways that, frankly, they would not have trimmed to if this economic reset had not occurred before. Now, as businesses cope with tight credit markets and the need to grow through organic success, these newfound capabilities will become ever more important.

The years ahead will be promising for our clients that have gained discipline and fitness during this economic reset. We look forward to being players in the game with them.