Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

Matthew M. Lowe

FDA Compliance

Eliminating the Digital Divide in Life Sciences, Part 1: Compliance Concerns

The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry

Published: Wednesday, April 24, 2019 - 12:03

It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset. The proof: Life science organizations (LSOs) lag far behind counterparts in other sectors in implementing digital technologies that are designed to streamline business and manufacturing processes.

In fact, while the rest of the world continually vies for digital differentiators, only 21 percent of LSOs even view digital disruption as a potential threat, according to PwC’s most recent Digital IQ survey. The causes of LSOs’ digitization reluctance are abundant and legitimate—security, cost, data integrity and validation concerns are just a few—but fears about regulatory compliance are usually at the top of that list.

Despite the main advantages of digitization, it’s understandable for LSOs to worry that rapidly evolving technology will lead to a loss of control and possibly pose a risk to compliance. Many LSOs have attempted to pursue digitization initiatives only to discover their ventures were overly ambitious, poorly defined, or years away from having any meaningful impact. Plus, the velocity at which digital transformation is reshaping consumer expectations, business models, and workforce dynamics seems utterly chaotic in a compliance-based industry.

The many reasons why LSOs are hesitant to rock the compliance boat by digitizing can be categorized into three general mentalities. The outline below lists these areas of concern and proposes digital remedies for each.

Fear No. 1: Disrupting the status quo

Compliance is a tricky business, and once an LSO finds a compliance methodology that works, it’s unlikely to shift its paradigm—even if current processes are inefficient, and the extensive benefits of evolution are indisputable. From the beginning, the industry’s guiding principle has practically been to go with what works, regardless of efficiency. In reality, what every LSO should be asking is, “Are my legacy systems and aging technology actually creating more risk than they eliminate?”

Manual systems and outdated technology inevitably lead to information silos and disconnected data, documents, and processes. As Amy Abernethy, chief medical officer of Roche subsidiary Flatiron Health, told The New York Times, “About 50 percent, if not more, of the critical details we need for research are trapped in unstructured documents.”

Digital antidote
For change to occur, it sometimes requires prodding from a higher authority. And nowadays, the very agencies that regulate LSOs are increasingly steering companies toward digitization. Regulators are focusing more each year on risk-based and data-driven approaches to compliance, as demonstrated by current initiatives like the FDA’s latest guidance on the monitoring of clinical investigations, the recent revision to the ISO 13485 quality management standard, and the FDA’s continuing efforts to send and receive more regulatory information via secure electronic portals like the Electronic Submissions Gateway. If regulatory bodies themselves want the speed and convenience afforded by digital solutions, what will happen to the companies that stick with their tried-and-true manual and paper-based processes? Like it or not, digital is the new status quo.

The modern regulatory environment confirms that automating compliance-related processes actually streamlines and accelerates compliance efforts. And, although most LSOs are still in the early stages of digital development, change is underway: 58 percent of LSOs report that digitization is a top management priority, and 79 percent expect to realize the value of digital initiatives within the next five years, according to a recent Deloitte Insights survey. LSOs that don’t make the digital leap risk incurring “digital debt” because the insights they need to develop innovations are obscured by inaccessible data and the fact they are unable to effectively adopt next-generation technologies like the internet of things (IoT) or artificial intelligence (AI).

More companies are recognizing that digitization is not only critical to optimizing compliance and quality processes, but that it also makes it easier for regulatory reviewers and auditors to find the documentation they need, precisely when they demand it. “You have to have a robust system in place so that when an auditor asks for a document and wants to see a history, you have the ability to quickly pull those records up,” says biotech veteran Tom Golden, senior manager of document control and training. “To an auditor, that’s huge.”

Fear No. 2: Compounding the complexity of compliance

Compliance is inherently difficult, and many LSOs assume that implementing an electronic system will make it even more convoluted and burdensome. Some fear that the more extensive an electronic system’s functionalities are, the steeper the learning curve will be. Or worse, what happens if the organization implements a robust digital system, and users reject it in favor of their familiar routines?

Digital antidote
Persisting with a familiar but inefficient manual system because you’re worried about the complexity or training demands of a new automated system is akin to resolving to walk to work rather than learning how to drive a car or ride public transportation. Automation doesn’t compound compliance burdens—it simplifies them.  

There was a time when new software system implementations automatically precipitated additional workloads for IT departments. But commercially available compliance and quality solutions are perpetually getting better at decreasing IT burdens, especially those that outsource IT via the cloud. As long as it doesn’t jeopardize validation or other compliance efforts, the push toward the cloud is fully supported by regulators and is therefore gaining traction in the life sciences. Reliable cloud-based solutions are increasingly proving that advanced technology should have the ultimate aim of simplifying—not overcomplicating—users’ lives.  

Anne Howell, director of training and development at the Community Blood Center of the Carolinas, worried that not having IT expertise would prevent her from overseeing the validation of a new electronic enterprise quality management system solution. “I do not have a computer background and am not computer savvy, so I feel like if I was able to do the validation and set the system up for our business, anyone would find the system to be very user friendly,” she says. “You don’t have to be a computer guru.”

Validation is a critical compliance issue anytime electronic systems are deployed, and it is becoming a key differentiator for software vendors that can deliver on promises of faster validation times. Using the unique MasterControl VxT (Validation Excellence Tool) solution, for instance, the provider’s customers have reported dramatic time and effort savings, slashing 336 hours in overall validation project preparation and reducing the actual project execution from 104 hours of labor-intensive activities to 20 hours of seamless experience.

In addition to validation, digital solutions are becoming more sophisticated in their ability to facilitate other vital compliance activities. For instance, software providers are continually developing dynamic solutions that optimize the management of batch records, postmarket surveillance, product registrations and submissions, and many more essential compliance functions.

Fear No. 3: The rift between the how and the why of compliance

Every compliance process should be a means of improving product quality and streamlining operations, not a drain on resources. But for all too many life science professionals, performing compliance activities is nothing more than checking off items on a to-do list. The incongruity between the way company personnel go about conducting their compliance-related tasks and the fundamental purposes compliance serves is very real, although often imperceptible. It’s easy to lose sight of the quality forest for the compliance trees. Consequently, many LSOs are oblivious to the reasoning behind regulatory requirements—or they may be afraid to discover problems that closer examination might expose.

Digital antidote
Maintaining compliance merely for compliance’s sake doesn’t make sense—especially if it doesn’t improve access to the data you need. To ensure that all compliance information and processes remain connected and quality-focused, LSOs need centralized systems.

By seamlessly linking data collection and management activities with their respective databases, digital enterprise solutions are proving to be the ideal means of ensuring data connectivity. And with the continual refinement of the technology in recent years, digital solutions have become the most reliable path to conformity with regulatory expectations for data integrity. An effective solution can enable an LSO to continually adhere to good documentation practices and meet the required levels of quality and risk management. Plus, reliable solutions will enhance visibility into compliance activities—not conceal potential problems—so digitally sophisticated companies are more likely to be aware of issues that could endanger compliance before they become emergencies.

The benefits of crossing the digital divide

There are many benefits to crossing the digital divide. These include:

Enhanced awareness across the enterprise of issues that affect compliance
A centralized digital system strengthens connections between data and processes, which enhances an LSO’s ability to keep everyone on the same page. An enterprise system’s training functionality is at the core of these efforts. “We soon realized that quality management system software would give us the ability to accumulate everything in one place and fill needed gaps in our training system,” says Wellington Foods president and COO Tony Harnack. “Speed to market is a big driver for us, so if we can cut a day or two out of the documentation control and review processes, that’s a big deal.”

Rebecca Thompson, vice president of quality at Cell Culture, echoes that sentiment. She reports that the company’s manual document review and approval processes that used to take weeks have accelerated considerably since going digital. “Now, if an important document is needed and it has time restraints for an upcoming project, it’s something that we can turn around in a couple of days,” she says.

Dramatic improvements in the efficiency and effectiveness of compliance processes
Digital solutions have introduced novel—and now indispensable—tools for administering the inspection and audit processes, as well as the risk assessment and risk management activities, that are integral to compliance management. Of the many beneficial features that Cell Culture’s digital solution provides, Thompson finds the ability to give auditors instant access to documentation the most valuable. “The auditors really like the visibility and that it isn’t a manual paper process that you need to go back and check by going through somebody’s binder,” she says. “It’s just pulling up a website on a screen and showing it to them.”

A systematized and consistent approach to compliance
LSOs are discovering that their learning curve and user adoption concerns are quickly offset by digital systems’ capacity to measurably decrease compliance complexities and establish reproducible processes. “We are able to formalize things we’ve done in the past through a more documented and selective process that is transparent and repeatable,” Michael Saiphoo, vice president and general manager of the original equipment manufacturer OMNI Flow, says of the company’s digital advancements. “When we introduce an aspect of documentation, we now have a formal way of tracking it from inception all the way through conclusion. We’re able to demonstrate through performance what we’re about as a quality company.”

Greater control over the compliance of vendors and service providers
The quality of a product is only as strong as its weakest point along the supply chain. To that end, digital systems enhance collaboration and communication between LSOs and their vendors, suppliers, contract research organizations, and contract manufacturing organizations. Donna Kelley, OMNI Flow’s quality manager, attests that the web-accessible portal to the company’s supplier management solution has empowered its suppliers to play a greater role in engineering and approval processes. “It gives them an opportunity to be an extension of us and the design and production of our product,” she says. “It also keeps us in direct contact with our suppliers in terms of their scorecard. They know where they stand with OMNI at all times. If they have quality problems, they can’t say they didn’t know.” Kelley finds it especially useful to have the ability to trend data in order to determine whether particular supplier relationships are worth maintaining. “I can see how many NCMRs [nonconforming material reports] that a contractor had this year, and I can make strategic, critical decisions on that supplier’s status,” she says.

Making digital dreams real

Digital technology is driving unprecedented efficiencies and innovations in life sciences, but it is not a magic wand. If your regulatory processes are broken to begin with, a digital solution will not miraculously make your compliance problems go away. But crossing the digital divide will propel an astute, improvement-centered LSO to the next level of product quality and streamlined operations. Powered by the numerous compliance and product quality enhancements it delivers, digitization also promises to significantly boost revenues industrywide. In fact, a recent PwC report estimates that the improved access to data and advanced analytics that digitization provides has the potential to unlock a $60 billion opportunity in the biopharma industry alone.

With a powerful digital system that unites compliance processes and product and quality data across the enterprise in its arsenal, an LSO can focus on enriching core competencies, recruiting top talent, and catalyzing innovations. Companies that successfully leverage digital solutions to devise advanced approaches to data compiling, sharing, and analysis will have the edge over stagnating competitors.


About The Author

Matthew M. Lowe’s picture

Matthew M. Lowe

Matthew M. Lowe, MasterControl executive vice president, is a mechanical engineer with more than a dozen years’ experience in medical device product development, product management, and regulatory compliance. He has launched more than a dozen medical devices and has five patents issued. His regulatory compliance experience includes writing a 510(k) that was cleared by the FDA and managing a multisite, multiyear postmarket clinical study for orthopedic devices. Lowe is the author of Convergence of Compliance and Technology: How Technology Has Changed Regulatory Compliance in the Past Decade (MasterControl, 2016). He holds a bachelor’s degree in mechanical engineering and an MBA.



Very insightful! Sadly,

Very insightful! Sadly, what's holding most LSO's back from automation, is analysis by paralysis... and they will lose to their competition who breaks through that.