By Bill Burke, President, Merit Solutions

It’s time to get a copy of 21 CFR Part 820 and see what it says. As you rustle through that 820 regulation, you will likely see that it talks about things far better known in the industry than Part 11 Requirements were before they became the focus of industry media attention. 820 is where the FDA spells out requirements for CAPA (Corrective Action/Preventive Action), NCMR (NonConformance Materials Reporting), and related quality management issues. While Part 11 is about controlling data per se, 820 is about controlling product quality.

21 CFR Part 820 provides standards for a company to set policies, operating procedures, guidelines and objectives that will promote product quality. Some of the key areas addressed by 21 CFR Part 820 include: purchasing controls (820.50); production and process controls (820.70); inspection, measuring, and testing equipment, e.g. ensuring routine and standardized calibration of equipment (820.72); process validation (820.75); receipt and quality inspection of final product (820.80); handling of non-conforming product (820.90); corrective and preventative actions (820.100); product labeling (820.120); storage procedures (820.150); and distribution (820.160).

You are absolutely right if you think that 820 is about nothing more or less than what it takes to make a good quality product. If the FDA wasn’t requiring you to do this type of quality watch, the stakeholders in the financial success of your company probably would. In the long run, quality control of this sort is about profits. Businesses that are in industries far away for the FDA’s reach, nonetheless invest considerable resources putting in precisely these type quality control systems to better manage product life cycles. If you don’t have these types of controls, you are susceptible to product recalls and all the costs associated with such messes. When you are in an FDA-regulated business a product recall is only the beginning of the story. Above and beyond the legal imbroglios that might ensue, there are nearly certain penalties and the ominous threat of the FDA enforcing a shutdown of your business.Even though 21 CFR Part 820 is relatively straightforward to grasp and for most manufacturers in the Life Sciences field comparably straightforward to implement, it can get messy when you get into the nuts and bolts of implementation—indeed, sometimes very messy.

Generally speaking, there are three pitfalls to beware in 21 CFR Part 820 implementation. The first is that same problem we observed vis-à-vis Part 11 implementation in the many companies with one foot still in the laboratory in which they were born, and where manual record keeping is still de rigeur. Manufacturers with manual methods of record keeping are poster children of inefficient companies. Usually, they cannot respond to customer orders in a timely fashion, especially if there are special request or orders. And woe upon the day when the FDA calls for an audit!

A growing number of companies have gotten past this habit of manual record keeping when it comes to 21 CFR Part 820 requirements and use some sort of computerized processes to track quality procedures. But many of those who automate quality control, at this date perhaps the majority, have done so by building separate systems just for these processes that do not integrate with their overall business system architecture. These separate systems for quality control tend to be costly and complex, and from a software engineer’s perspective, clunky and inelegant behemoths. Since these systems need to hoard data in order to be accurate, what happens is that you end up keeping data in two places—one set in the quality control automation and one set in the company’s enterprise-wide business system. This means every time data is updated in your company, you need to update it twice. Once in the overall business system and once in the quality control system. Picture it as two computers sitting there side by side talking to each other constantly, with each being distracted from their job at hand.

But perhaps the real reason why these clunky automated methods for 21 CFR Part 820-related quality control have endured this long is because of the relative time lag when it comes to 21 CFR Part 11 implementation in the industry. This is the third problem. When your company finally gets around to tackling 21 CFR Part 11, a separate system for 21 CFR Part 820 will likely DOUBLE both the complexity and costs of the job. This is because you will have two separate systems that need to be brought into compliance. For example, you would have to build audit trails both in your quality control (Part 820) automation and in your company’s general business system. Similarly, both systems would need to have electronic signature capabilities built in, etc. This can get very messy indeed!

With forward thinking, you will find that there really is a different approach that spares you the quagmire. If you keep your focus on building one company-wide common information infrastructure and avoid separate systems like the plague, you save yourself a lot of headache in both the short and long run. Instead of spending a bundle trying to find systems integrators who attempt to hobble processes together that do not share a common architecture, look for an all encompassing business system with compliance components that work with the underlying architecture of that application. This is the least costly and most manageable route. For example, a typical mid-sized firm using Microsoft Great Plains can get add-on modules for total 21 CFR Part 820 compliance fully implemented for $50,000 or less. Compare the costs of maintaining two separate database systems -one just for 820 compliance and one for overall business functions-and the costs of wrapping Part 11 compliance around these two separate and disparate systems and you can easily see which way to go. If you haven’t gotten around to 21 CFR Part 820 compliance, there really is no reason to delay. You’ll save yourself an enormous headache if you think of Part 11 and Part 820 at the same time, and more to the point, make sure that they share one data infrastructure in your organization.

Bill Burke is President of Merit Solutions (www.meritsolutions.com), that specializes in software for full FDA CFR 21 Part 11 compliance for pharmaceutical manufacturers and other Life Sciences firms using Microsoft Business Systems. Questions can be forwarded to Bill Burke at bburke@meritsolutions.com, 630 – 510 – 3238.