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Easing Regulatory Compliance

How Informatics Standardization can Help Labs Achieve Quality and Ease Compliance Burdens.

by Mark Harnois
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Depending on your perspective, you may view regulatory compliance as a necessary but unwelcome expense, a hurdle in the race to market, a vital measure to protect public health and safety, or perhaps all three.

Whatever your views, you probably don’t see regulatory compliance as a significant factor in profitability—but it can be. Think, for example, about the impact on profitability if an organization spends an inordinate amount of time and effort achieving and maintaining compliance. If staff members are investing more hours meeting compliance requirements than performing tasks that build their business, productivity, and profitability will be negatively affected. Likewise, too little focus or an ineffective use of resources may result in the issuance of a consent decree that could dramatically impact profitability.

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For many companies, maintaining compliance is not a small problem—and it’s getting bigger as the regulatory burden grows. This can be attributed in part to the considerable challenge of harmonizing operations that arise as the result of mergers, acquisitions, and globalization in biopharmaceutical, food, and other regulated industries.

One effective way to ease the compliance burden is by standardizing the laboratory informatics software. This can streamline processes, improve workflow, increase productivity, and, thus, boost profitability. At the same time, it can deliver other welcome benefits, including improved product quality, reduced waste and variability, and simplified training and support.

The heterogeneous laboratory

To appreciate the impact of laboratory informatics standardization, you first have to look at the apparent disorganization that exists in today’s laboratory environments. Most companies use an assortment of diverse analytical instruments from a variety of vendors. The data generated by those instruments is often collected and managed by multiple software products, few of which are integrated with one another. There are even laboratories that still keep records using paper and pen or simple spreadsheets. For companies with multiple laboratories around the globe, the problem is compounded; often, each lab does its own custom workflows with no common processes or sharing of best practices.

Laboratories that have not standardized their software are thus more likely to have inefficient workflow, productivity issues, and a greater risk of human error in their compliance reporting. But perhaps most significantly for their long-term prospects, companies with nonstandardized laboratories lack an effective means to achieve significant process improvements.

How big a burden is regulatory compliance?

Laboratory-related regulatory requirements vary by industry, with some of the most stringent rules governing the pharmaceutical and biotech industries. In the U.S., those requirements are primarily driven by the U.S. Food and Drug Administration’s (FDA’s) GxP regulations, which provide mandatory rules or Good Manufacturing Practice for Finished Pharmaceuticals. The regulations are intended to ensure that a manufactured drug is safe for users and meets its intended use. These regulations are captured in Title 21 of the Code of Federal Regulations, or 21 CFR, as it is commonly known, of which parts 211 and 11 are most important to life sciences in general. 21 CFR Part 211 spans a wide range of components, from equipment and facilities to personnel and processes. 21 CFR Part 11 is focused exclusively on electronic records and electronic signatures, with the intent of ensuring that the records generated on a computer are as trustworthy and reliable as paper records and manual signatures.

Like most government regulations, 21 CFR only defines the rules; it does not dictate how to achieve compliance with the requirements. Typically, companies enforce compliance by implementing their own controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems.

Documentation is key. In a paper-based world, that means creating, managing, and storing volumes of paper records. In the realm of electronic records, documentation is software-based. FDA passed 21 CFR 11 in order to support the use of electronic records and signatures.

Companies have an added incentive for implementing electronic records; the traceability of records essential to compliance is also key to making processes more efficient by eliminating waste and reducing variability. Finding information in electronic documents is as easy as Ctrl + F (much more efficient than paging through 25 users’ notebooks).

What laboratory standardization can accomplish

Laboratory standardization supports electronic record keeping and regulatory compliance efforts through the use of a minimum number of common software products across all of an organization’s laboratories. By standardizing on a single chromatography data system (CDS), for example, to manage all its liquid and gas chromatography instruments, a company gains the benefits of easier data sharing, easier training, improved skills management, streamlined validation effort, simpler support, and easier information exchange among different systems. With a single data format across all instruments, record keeping for compliance purposes is simplified.

Laboratory standardization works—as proven by the experience of a top 10 global pharmaceutical company that recently standardized its laboratory informatics environment. Over a number of years and several mergers and acquisitions, this company found itself with more than 15 manufacturing sites located around the world. The company found it challenging to produce the same product with the same specifications at several of its sites while successfully passing regulatory audits, sharing information, integrating with laboratory information management system (LIMS) and enterprise resource planning products, and keeping training costs down.

The pharmaceutical company made the strategic decision to standardize on a common CDS, LIMS, and scientific data management system (SDMS) across all its laboratories. In short order, the company gained a better handle on regulatory issues, found information exchange easier, was able to integrate with other systems, and, ultimately, gained greater visibility into the operational processes at all sites. The initiative helped the organization achieve its quality and regulatory compliance goals. At the same time, the added visibility to information enabled the company to reduce waste and variability in its processes, ultimately reducing costs and boosting profitability.

How standardization eases the compliance burden

Standardization supports regulatory compliance in several ways; first, by enabling common laboratory workflows, such as chromatographic method validation.

Typically, there is an inherent variability and waste in workflows from one laboratory site to another. The use of a common software platform makes it possible to develop and refine a robust, reliable, validated method that all laboratory staffers can use. The result is less variability in the product quality testing and easier adherence to compliance requirements.

Because leading SDMS products support electronic worksheets, the use of a common SDMS also enables standardized documentation workflows. This improves the quality of record keeping during a product quality test and eliminates the risk of manual transcription errors.

Laboratory informatics standardization makes it easier to capture and exchange data from multiple, heterogeneous instruments at multiple sites. Standardization also makes it possible for an organization to take enterprisewide advantage of helpful tools and services, such as compliance tools and services. Together, all these factors can bring greater automation, efficiency, and accuracy to the ongoing compliance effort.

Standardization is a growing trend

On a larger scale, standardization has become a key component of the drive to accelerate development and maximize productivity in the increasingly competitive pharmaceutical industry. For example, in the discovery phase of drug development, more and more companies are standardizing laboratory procedures such as the purchase of reagents as well as the washing of glassware. From the laboratory informatics perspective, e-notebooks are being used to standardize biology and medicinal chemistry documentation workflows so chemists and biologist can focus more on science and less on documentation.

But standardization is nothing new. Standard operating procedures have been employed in the pharmaceutical industry for many years. LIMS solutions were introduced as early as the 1980s to standardize sample tracking and scheduling. And since the 1990s, companies have used SDMSs to standardize the format of printed records and to capture and catalog all analytical data in a central repository.

More recently, the International Society for Pharmaceutical Engineering formed the Good Automated Manufacturing Practice committee to promote standardized processes based on best practices in pharmaceutical manufacturing.

Laboratory standardization also mirrors the broader standardization occurring in information technology (IT). The advent of server virtualization has made it possible to standardize the IT operating environments that serve analytical laboratories, and desktop virtualization solutions such as Citrix XenDesktop and Windows Remote Desktop Services are standardizing the user experience across devices and environments.

All these developments suggest that laboratory informatics standardization is one of a number of strategies organizations should consider as they seek to streamline their regulatory compliance activities.

Taking the first steps toward standardization

Launching a laboratory standardization initiative may make strategic sense, but the effort requires careful planning and due diligence. The more laboratories and software products an organization has, the more complex the effort, and some laboratory personnel may be resistant to changing their preferred tools and methods.

With those issues in mind, we recommend that companies contemplating laboratory standardization begin by taking the following five steps:

1. Get a handle on your existing environment and software investments. Do an enterprise-wide inventory of instruments and software installations and licenses to better understand the size and scope of the effort. Make sure to take into account the number of integration touch points that are maintained to keep data flowing smoothly and the validation effort required for each upgrade to informatics point solutions. Do software upgrades break existing data integration points and require a significant amount of effort to maintain and revalidate?

2. Investigate software products to standardize on. Even if you already have a particular solution in mind, the standardization initiative provides an opportunity to ensure that you select the product that best aligns with your organization’s requirements and preferences. As you do, look for software products that include compliant-ready support capabilities.

3. T ake advantage of compliance-ready features already built into your laboratory software. Many companies may not realize that their existing software products already include compliance support features. Making use of these features can ease the regulatory compliance burden today while helping the laboratory staff become familiar with new skills needed to implement standardization.

4. C onsult your informatics vendor about services to support the standardization process. Leading informatics vendors offer services that can ease and speed the transition to a standardized laboratory. An investment in these services can deliver major savings in the long run.

5. E xplore how standardization can work hand in hand with Lean Six Sigma and other quality/process improvement efforts. Besides better supporting regulatory compliance efforts, laboratory informatics standardization can create a foundation upon which to build other, equally beneficial programs to streamline processes, improve quality, and foster continuous improvement and innovation.