Merit Matters Blog

Today’s social connectedness, mobile devices, and growing opportunities for interaction “any time any place” have changed the way many live and work. People are increasingly dependent on connections across the global network—interlocked in this connected reality.

In order to gain the insight needed to make better decisions, organizations need an end-to-end business solution that integrates all areas of their business and provides managers - as well as individual team members and contributors - with the information they need to make the right decisions at the right time!

Modern business solutions like Microsoft Dynamics AX not only connect people inside and outside the organization, they also give them context and insight which drives better decisions and boosts productivity. An important focus of Microsoft Dynamics AX is to drive connections with people, with customers and with business partners across processes, data and the ecosystem in which organizations operate. This focus on connected organizations includes the vision of anywhere, in-context collaboration services that links people and companies to the right people in the right place, in the right context, at the right time, across multiple avenues of communications.

By implementing a fully integrated ERP system like Microsoft Dynamics AX - encompassing everything from sales and marketing to production and accounting - organizations can improve the accuracy of the information upon which decisions are based because each module of the software is tied together and information flows freely among them. Everyone from the top floor to the shop floor can have access to the business intelligence information they need to drive business success across the organization:

• Keep current on changing business conditions - Accurately monitor current business activity, and compare it to historical activity and future plans to give people the contextual information they need to keep performance on track. Microsoft Dynamics AX delivers many integrated monitoring tools to help your people access the most relevant, accurate, and timely information about your business.
• Gain insight into your business - It's not enough to gather accurate and timely data—people need powerful and easy-to-use analysis tools to help them understand context and trends. Microsoft Dynamics AX business intelligence functions provide people with the insight they need to take quick action and pursue opportunities.
• Budget, forecast, and plan effectively - Microsoft Dynamics AX offers flexible planning tools to help you compare budgets, forecasts, and plans to actual performance. It also gives you the ability to update budgets and plans on the basis of new data and analyses to help your business stay competitive.

Microsoft Dynamics AX removes the impediments that generate friction within the organization and provides people with a broader array of insights and actions across internal and external connections. With greater transparency, agility, and insight, your people can make better, more informed decisions - enabling you to transform into a Dynamic Business.

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.

In a couple of recent posts, we've discussed how companies can transform compliance into business benefits and reduce the cost of compliance. Now let's talk about how system controls in Microsoft Dynamics AX helps with data integrity, data security - enabling organizations to put the controls in place to monitor changes in critical data and policy violations.

First, any data that is posted into Microsoft Dynamics AX is updated automatically throughout the application modules via the setup of posting profiles. So when data in one module is changed, the change is automatically updated in another, providing real time and up-to-date information throughout the system.

Second, with Microsoft Dynamics AX you can prove that your data is trustworthy and has not been tampered with. For example, you can control access to data throughout Microsoft Dynamics AX by managing security restrictions on forms, records and data fields for specific user groups and domains, and define and assign rights according to how you want security restrictions managed.

Third, the Record Center in Microsoft Office helps make sure that vital company records, including critical documents (for example, financial reports, supplier contracts, and customer correspondence), are properly retained for legal, compliance, and business purposes and then properly disposed of when no longer needed. The Record Center in Microsoft SharePoint helps control that records are never automatically modified by the system and helps prevent direct tampering of records by versioning any changes made to document contents and by auditing specific types of changes.

It’s also possible to control data integrity through user-defined and centrally managed controls to eliminate manual processes and the possibility of human error. The audit trail system in Microsoft Dynamics AX enables you to identify the origin of an entry; the user who created the entry and the entry date and time. In addition, the Microsoft Dynamics AX Expense Management feature helps managers define and enforce company expense policies to which employees will be held accountable when entering expense reports. Expense policies can be defined to either:

• Warn an employee that they have violated a policy but allow them to submit their expense report, or
• Prevent an employee from submitting the expense report until they have made the necessary changes to adhere to the policy.

Microsoft Dynamics AX delivers an integrated and automated solution designed to help you manage the risks and costs associated with meeting compliance requirements. Furthermore, it extends your investment in Microsoft products and technologies, and gives you deeper visibility into and control of business practices that you can use to generate a competitive advantage.