By Gregg Klein
The ability to access and analyze quality management and compliance data is important to all companies, but it’s crucial for those operating in life sciences, medical device manufacturing, consumer products, and other highly-regulated industries. Quality management systems (QMS) complete part of the job by tracking compliance as products travel down the supply chain. However, they commonly lack the analytics and reporting capabilities that quality, manufacturing, and regulatory affairs professionals need to transform raw data into actionable information.
Many companies use Microsoft Excel spreadsheets for this purpose, but struggle to harness high volumes of data for business intelligence (BI) and ad hoc analysis. Others have to rely on their IT departments to develop complex SQL scripts to locate, extract and reassemble data.
These workarounds are speed bumps that slow analysis and decision making—and ultimately, product time to market. Not to mention, they make it more challenging for companies to follow and manage the strict procedures required for product manufacturing and safety testing.
To solve this problem, software vendors have the option to embed BI and analytics software, equipping customers with self-service reporting, data visualization, and ad hoc analysis capabilities to glean needed insights from business data without impacting the company’s transactional database or waiting on IT for custom reports.
This article discusses how embedded analytics can help companies ensure product efficacy and safety across their enterprises and supply chains.
Stay Compliant with Strict Regulations
Highly-regulated industries often face spontaneous spot-checks from regulatory agencies, so detailed reports may be requested with little notice. While these random checks prioritize safety, it’s difficult to prepare for them without embedded analytics.
For example, in the pharmaceutical industry, an agent from the U.S. Food and Drug Administration (FDA) may visit a manufacturing facility for a random inspection. If the facility does not comply with all regulations, the inspector will post a notice saying that proper quality management procedures are not in place. The situation gets even more complicated as the “extended enterprise” increasingly includes partners and contract manufacturers, making it progressively difficult to enforce quality across a global supply chain that includes external companies and offshore entities.
Not only are companies accountable, they also must hold third parties to high safety standards. It’s vital for companies to extend control and oversight on how information is shared and quality processes are structured. Embedded advanced reporting capabilities make it easier than ever for companies to collect the vast amount of information required for QA, deviation tracking, and non-conformance management all-in-one platform.
Access Necessary Tools Anywhere
With globally located managing partners and manufacturers, organizations need unhindered 24/7 access to quality management and BI tools anytime, anywhere.
Going back to the FDA spot-check example, if a facility manager realizes they need to quickly pull a report while off-site, that’s no problem when using a mobile-friendly quality management solution with embedded analytics. Instead of scrambling to find a compatible desktop computer, they can use their smartphone or tablet to retrieve the most up-to-date information. Accessing product safety, quality, and compliance data anywhere expedites reporting, and most importantly informed decision making.
Keep Data in the Right Hands
As mentioned, organizations in highly-regulated industries must meet stringent security requirements, so it’s integral that their quality management system and reporting capabilities accommodate multi-layered security procedures. All restrictions that apply within the QMS must carry over into reporting displays. A flexible, forward-looking architecture with embedded analytics enables organizations to maintain tight control over proprietary and sensitive data at varying levels based on user roles and authorizations.
For example, a senior-level employee may be able to see sensitive information that a temporary employee shouldn’t access. Having an embedded BI solution ensures that a complex security model remains in place with no disruption in hierarchy. These safeguards make compliance reporting easy and give companies peace of mind.
Create Visually-Compelling Data
The powerful combination of a quality management system with embedded analytics seamlessly delivers charts and other visuals that help quality, manufacturing, and regulatory affairs professionals make sense of large amounts of data. Interactive dashboards that compile incident, recall, and quality information through graphics allow companies to capture imperative information with engaging reports by dragging and dropping data with the click of a button.
However, interesting imagery can’t come at the sacrifice of advanced analytics, so it’s important that these visuals capture all the sophisticated information organizations must track. With analytics embedded right into a QMS, users can quickly spot trends, outliers, and compliance issues. This way, manufacturers can address problems before they erupt into a recall, ultimately saving millions in revenue and preserving brand equity.
Save Time and Frustration
Using Excel spreadsheets to sort and analyze data according to industry-specific protocols is overwhelming, error prone, and time-consuming at best, especially in a time-crunch. Even if an organization has an independent BI solution, quality, manufacturing, and regulatory affairs professionals may not be trained on it, forcing them to rely on the IT department to locate and extract data for customized reporting.
As the old adage goes, time is money. Organizations need to be able to quickly pull analysis and run reports using existing quality data from one integrated quality management system they’re already familiar with.
This all boils down to putting the right tools in the right hands at the right time. With analytics and advanced reporting embedded right into their quality management system, companies can dramatically expedite and simplify complex processes. Self-service BI and analytics capabilities enable customers to make faster, better decisions that reduce risk and improve safety across their enterprises and supply chains.
Gregg Klein is director of product management for Sparta Systems, where he is responsible for leading the TrackWise and Stratas Quality Management product management group. Klein focuses on the continued advancement of Sparta Systems’ leading quality management platforms, providing robust and efficient solutions to customers in highly-regulated industries.
Sep2017, Software Magazine