“I just spent the last three days building a report for the boss on the accept / reject rates at each inspection point. I got an order list from sales. I found paper reports on the inspections. I put it all together in a spreadsheet with beautiful colors and formatting. It was a lot of work and I am proud of the report.”
“That sounds great. Why the glum look?”
“The boss wants even more details. In addition, this report needs to be ready at the end of every month. I cannot spend that much time. I need a better way to publish this report.”
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Microsoft named Leader for 9th year.
Read the full details on why Microsoft was named a Leader for the 9th consecutive year in the Gartner Magic Quadrant for Business Intelligence and Analytics Platforms.
These days, there are many companies offering Business Intelligence (BI) solutions. While some companies may be offering a cheaper solution, one must consider the benefits of working with a preferred Independent Software Vendor (ISV) before making a selection on package price alone. Though the ISVs that are closest to an ERP software company may be more expensive, that close relationship can pay dividends.
These days, more and more companies are investing in Business Intelligence (BI) and it is driving today’s business decisions. Mounds of data can be collected across multiple data sources, but it takes BI to make sense of it all and present a unified story of how a business is doing and what it might encounter in the future. BI solutions have matured and many products do a great job of sifting through the data to present insightful analytics and powerful predictive models. So what’s next?
Just the term big data is enough to turn some medium sized businesses away. After all, aren’t business intelligence solutions used to collect and analyze large amounts of data reserved for large organizations? Not really, in fact, any business that has been around for a year or more likely has “a ton of big data” ready to help you make better decisions.
So it isn’t the lack of data that holds many medium sized businesses back. Often times, it is the lack of how big stat can help and how to go about leveraging all of that information.
Business Intelligence includes collecting and organizing data from your ERP system to make insightful business decisions. These days, every ERP solution collects and stores a massive amount of data, but if that data cannot be accessed by people in intelligent ways, then the power of the information is limited. So how do the decision makers get the information they need? Reports generated from the ERP database present information in a manner that makes the most sense to the business user.
When a small manufacturing business first gets started, the employees are usually tight-knit enough to exchange information informally by asking the appropriate knowledge expert. In fact, this type of direct request may be the only method of collecting the information if it is stored differently than your own domain-specific information. For example, accounts receivable may keep information in a set of Excel files, while Sales keeps theirs in a proprietary software program. As an organization grows, the need to be able to view data throughout the business in real-time becomes crucial.
In todays technology obsessed world, even the delivery of healthcare is dependent on software driven devices. Some are standalone, others are networked together. With the ever growing web of connectivity and the movement towards personal medical care, security issues predictably arise. Hacking has become so common place, we are no longer surprised when it happens. Losing your credit card information is bad enough but what if a wearable device was compromised by an anonymous cyber criminal? Remember, the motivation for someone to control another individuals pacemaker or insulin pump is irrelevant, the point is that if something can be hacked, someone will find away to do it. Hackers may use these devices as another means to troll for personal information.
Todays 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 intelligenceÂ information they need to drive business success across the organization:
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) -Â 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.