Intelligent Quality Maturity: Driving Business Success

Intelligent Quality Maturity: Driving Business Success

Quality is central to life sciences. Achieving intelligent quality maturity can position your company for success in a dynamic, challenging marketplace.

2© Copyright 2019 ZenQMS. All rights reserved.


Ed Morris has seen firsthand the life-or-death importance of quality data in life sciences.

As an independent auditor specializing in IT quality, his first audit was a “for-cause” audit of a Phase II trial. The veracity of the clinical data had been called into question because of a bug in the randomization sys-tem. Dozens of patients received an active ingredient, when they should have received a placebo. During that period, there were several serious adverse events and one death.

Because it was a double-blind trial, Morris didn’t have insight into whether there was a causal relationship between the error and the events. “But I did find the contract research organization’s software documentation and testing practices were severely lacking, and there was no traceability,” he says.

As a result, the trial was halted, the in-vestigation began, “and there were serious financial consequences for the CRO and the software company alike,” he concludes.

Mature Quality Management and Competitive Advantage

Life sciences companies are aware that quality is a safety and business prerequisite, and that effective quality management goes beyond software and systems. It requires an overall quality culture driven from the high-est levels of the organization – from biophar-maceuticals and medical device companies to their manufacturers and partners.

“A deeply embedded quality culture is a crucial success factor for life sciences com-panies,” believes Kip Wolf, quality leader for Tunnell Consulting. Wolf reports that in at least one case, the FDA specifically warned a life sciences company on both “quality prac-tices” and “quality culture.”

It’s this combination of digitized quality solutions and a leadership-sponsored qual-ity culture that results in intelligent quality maturity. Intelligent quality maturity takes QMS to the next level. It eliminates manu-al efforts, holds employees accountable for compliance and training requirements, and provides quality leaders a real-time view of the overall compliance health of the busi-ness.

A mature QMS drives quality across three dimensions: people, process and technology. It enables confident compliance (people), op-erational excellence (process) and intelligent accountability (technology).

The last item is a critical element in ‘con-necting the dots’ of these core items. How easy it is to document your defined quality imperatives and process? To share it with in-ternal and external constituents and assess your overall compliance status and orienta-tion? Many companies with advanced, ma-ture states for it’s people/culture and process struggle with this last part.

Companies have traditionally implement-ed in a variety of ways, from binders of paper documents to Microsoft Excel spreadsheets to enterprise systems. A decade ago, only established, commercial businesses had the resources for an enterprise quality manage-ment system (eQMS). Today, affordable and accessible solutions are available to regulated businesses of all sizes, which can reap the same benefits of a mature – and intelligent – quality system.

Technology now offers software and apps that can learn, adapt and autonomously take action on data faster than any human could. Think of Uber’s ability to optimize your trip or Amazon’s recommendations or even gmail’s suggested replies.



The Integrity Imperative

Quality maturity begins with embracing the business-critical nature of quality man-agement. Quality assurance leaders recog-nize that life sciences operations are built on quality management. But all executive lead-ership must share this view.

“Maintaining a quality culture is ultimate-ly the responsibility of the c-suite, as is mak-ing sure the resources and systems to support that culture are in place,” says Judy Carmody, founder and principal consultant of Carmody Quality Solutions. “Instilling a quality cul-ture early on can prevent noncompliance and poor performance in the long term – protect-ing patients, the bottom line and the overall financial health of your company.”

The FDA concurs. “It is the role of manage-ment with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employ-ees are encour-aged to identify and promptly re-port data integ-rity issues,” says the FDA’s recom-mendation for drug current good manufacturing practices (CGMP). The directive goes on: “In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.”1

And FDA compliance is really where qual-ity management starts. For instance, quality data should conform to the FDA-established ALCOA+ framework for data that is attrib-utable, legible, contemporaneous, original,

accurate and more. Other important stan-dards include ISO 9001 and GxP guidelines for Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manu-facturing Practices (GMP).

Intelligent Quality Maturity for Faster Time to Market

But implementing a QMS isn’t the end of the quality road. It’s the beginning of a jour-ney that should lead to quality-first processes and practices that underly a company’s busi-ness and culture.

“Pharma is a high-stakes game,” Morris points out. “Emerging companies focus all their financial, human and infrastructure resources on developing the product and getting it to market. But they soon become aware of the need for quality measures and documentation of those measures – usually after they have to deliver a quality report to

regulators.“They want to

get to commer-cialization, be-cause that’s when the revenue starts flowing,” he con-tinues. “But with that milestone comes responsi-bility and risk.”

That’s why companies should pursue intelligent qual-ity maturity. (See Figure 1.) Intelligent qual-ity maturity helps organizations assess their current state of quality and create a road map for achieving a quality-driven business. It equips them to automate core tasks, elimi-nate mistakes, and get to market faster and more cost-effectively.

“If everyone in the company, including senior management, has a clear view of quality, then your entire company becomes more intelligent.”

—Mike Butler, Founder and CEO, Unit Life



Intelligent accountability

“The biggest advantage of a digital quality management solution is that it makes qual-ity transparent,” says Mike Butler, founder and CEO of Unit Life Sciences. “When you have quality transparency, you can reach in-telligent quality maturity. If everyone in the company, including senior management, has a clear view of quality, then your entire com-pany becomes more intelligent.”

The Paper Problem

Trouble is, any companies – especially startups and smaller biopharmas and their partners – still manage quality by using pa-per documents and spreadsheets. “Manual

approaches are prone to error, they’re diffi-cult to track and they don’t scale well,” says Morris, who is now managing partner of The Morris Group.

And while spreadsheets are electronic, they require manual input. As a conse-quence, they’re time-consuming, at risk for mistakes and apt to become unwieldy as needs grow. That’s especially true when spreadsheets are used to comply with FDA training requirements. For five employees, spreadsheets might be effective. For 100 em-ployees and thousands of training records, they’re untenable.

“I’ve worked with companies that spent an enormous amount of time building manual

Figure 1: Intelligent Quality Maturity Model

Manual Proactive IntelligentPeople ●● Low accountability

●● Reactive mindset●● Disconnected KPIs

●● Quality team●● Shared quality

responsibility●● Compliance

preparedness

●● Real-time KPIs●● Executive

champions●● Compliant culture●● Staff knowledge of

SOPs

●✓ Confident compliance

Process ●● Failed audits●● Time-consuming

inquiries●● Poorly defined SOPs

●● Defined SOPs and workflows

●● Advance audit preparation

●● Clear document lifecycle

●● Managed training

●● Defined and engaged processes

●● Automated document lifecycle

●● Global standardization

●● Continuous improvement

●✓ Operational excellence

Technology ●● Paper or spreadsheets

●● Local access only●● Manual workflows

and signatures

●● Compliant e-signatures

●● Compliant training system

●● Dashboards●● Automated

workflows●● Business

intelligence and reporting

●● Simple administration

●✓ Intelligent accountability



tracking systems,” says Tim Reinhardt, senior consultant and site manager for RMC Phar-maceutical Solutions. “By definition, they can’t be updated in real time. And you have no visibility into where documents are, who’s reviewing them and what their status is.”

Even worse, a manual approach can have significant negative business impacts. The life sciences industry faces tremendous pres-sures – from evolving regulations, an un-certain insurance landscape and heightened customer expectations for everything from low prices to societal accountability. Quality issues extend to the end customer. And they can stop a business in its tracks.

The Digital Divide

The solution is digitized quality manage-ment. “With a digital solution, all stakehold-ers can easily see where documents are, who has reviewed them and what their status is,” Reinhardt says. “You have a single repository for any data you need to access in the future. And quality management moves from reac-tive to proactive.”

Companies increasingly recognize the digitized quality imperative. By the end of

2018, 14% of manufacturers had started a journey to Quality 4.0, which combines tra-ditional quality methods with digital tech-nologies to improve operational excellence. Pharmaceuticals in particular are among the early adopters, deploying Quality 4.0 across product development, clinical trials, labora-tories and more.2

Life sciences companies also recognize that digital technologies can transform not only operations but also ecosystems. For in-stance, 85% see tech companies as the driv-ers of digitization, and 63% view them as co-operative partners.3

But such acknowledgement hasn’t led to action. Only 23% of manufacturers had ad-opted an eQMS by 2017.4 And many com-panies still rely on disparate quality systems and data sources – a primary barrier to achieving quality. (See Figure 2.)

“The right quality management solution is fit for purpose,” Morris says. “Quality man-agement systems are no longer all-or-noth-ing, manual or enterprise-class. Look for a solution that’s cost-effective to implement with the functionality you need now, but that can scale up as your needs become more

Figure 2: Top 5 Impediments to Quality5

Lack of visibility into suppliers' quality

No formal process to manage risk

Quality is a department, not a responsibility

Quality metrics not measured e�ectively

Disparate quality systems and datas sources 37%

37%

36%

24%

23%



complex. In fact, make that solution part of your launch timeline.”

Such a solution transformed quality man-agement at Xerimis, a provider of custom-ized clinical packaging services, based in Moorestown, N.J. The company serves phar-mas, biotechs and clinical research organi-zations around the world.

Each year, Xerimis faced dozens on on-site audits by its clients. It needed a quality management solution that met not only its own needs but also those of the companies it serves.

Xerimis recognized that a digitized solu-tion would be more efficient and effective than its existing manual approach. But it discovered that an enterprise solution would require at least $1 million in upfront invest-ment, plus ongoing costs for hardware, soft-ware licenses, maintenance and support.

The solution was an eQMS, provided us-

ing a software-as-a-service (SaaS) model, that delivered almost immediate return on investment (ROI). Xerimis can now demon-strate that standard operating procedures (SOPs) are in a state of control. It has also reduced onsite audit time by more than 50%, and auditor feedback has been overwhelm-ingly positive.

The Downsides of Delay

Despite the clear advantages of an eQMS, many companies delay implementation. For instance, startups may believe they’re too small to need one.

Butler disagrees. “To manage quality manually, you need more people, and most small companies can’t afford that,” he notes. “If you think manual is cheaper, you’re not considering the full learning and scalability expense of manual processes.”

“The right quality management solution is fit for purpose. Look for a solution that’s cost-effective to implement

with the functionality you need now, but that can scale up as your needs become more complex.”

—Ed Morris, Managing Partner, The Morris Group

“We’ve been able to reduce onsite audit time by more than 50%, because we’re able to provide

auditors access to review documents.”

—Jason Bissey, Director of Quality Assurance, Xerimis



Butler recommends a careful cost-benefits analysis of installing, maintaining and using a digital solution. “It’s difficult to see how a properly priced and configured solution won’t pay for itself in a very short period of time,” he says.

Of course, emerging pharmas often deal with competing budgetary priorities. But if quality issues don’t hit the budget in one place, they’ll show up in another.

“Smaller firms rely on consultants,” Re-inhardt points out. “If you compare the cost of paying a consultant to waste time with a manual system against the cost of an eQMS, right there you’ll drive ROI. And if you’re better prepared for an FDA visit, you’ll get your money back very quickly.”

Finally, some companies think they can wait till they achieve commercializa-tion to invest in an eQMS. How-ever, “by the time you’re ready for commercialization, it’s too late to think about quality management,” Morris insists.

“I’ve gone through many product launch-es with my clients,” he recalls. “During that launch process, there are preapproval in-spections, readiness inspections and audits. You need to have your quality documenta-tion in order before that. After you’ve fallen overboard, it’s too late to learn how to swim.”

Quality Documentation and Measurement

Document management is an important aspect of quality – and an area where an

eQMS is a must. “Most small pharmas are a collection of people in various locations,” Reinhardt observes. “So documents are gen-erated in one place and then shared with remotely located employees, contractors and consultants.” If quality management is paper-based, document sharing and routing can become a logistical nightmare.

Companies need FDA-validated docu-ment management that automates work-flows, supports e-signatures, tracks approv-als, enables real-time updates, provides visibility across stakeholders and offers com-plete traceability.

Document management was a major chal-lenge for Avara Pharmaceutical Services, a

provider of con-tract manufactur-ing and technical services, based in Norwalk, Conn. The company is regularly au-dited by the FDA and by its clients, which include global pharma-

ceutical brands.In the past, Avara relied on legacy soft-

ware and manual processes. The result was frequent delays and missing documents.

But after implementing an eQMS, the company eliminated all its lost-document is-sues. And it can now pull an accurate list of SOPs and related documents during audits.

Measurement and analytics are also key. Businesses should measure progress toward quality goals based on industry require-ments. For example, trainings must be per-formed within specified time periods, and corrective and preventive actions (CAPAs)

“If you compare the cost of paying a consultant to waste time with a

manual system against the cost of an eQMS, right there you’ll drive ROI.”

—Tim Reinhardt, Senior Consultant, RMC Pharmaceutical Solutions



have time limits. SOPs also have built-in metrics. An effective eQMS supports such measurement – and should also provide in-sights into quality efficiency.

“Measure on a regular basis,” Reinhardt advises. “If you measured your budget once a year, you’d be too late to respond to prob-lems. The same is true of quality. You need real-time insights.”

That visibility can drive a shift from reac-tive to proactive quality management. For example, knowing that several SOPs will be-come due at a given time can dictate an ap-propriate reallocation of resources.

Real-time visibility and control also en-able companies to safely and ef-fectively manage change. With an eQMS, all pro-cesses follow a defined protocol. Any deviation from the con-trolled state – a change to a ma-chine or a supplier, say – is documented with a risk assessment and verified change man-agement.

The Transformative Power of Quality Culture

Ultimately, to achieve intelligent qual-ity maturity, organizations need to embed a quality mindset throughout the culture. “You can put in the right software, but if you don’t have the right values in the company, if your people don’t take it seriously and don’t use it, it won’t work,” Butler warns. “Qual-ity needs to be ingrained in everyone, every minute.”

But an effective eQMS can help. “One problem with a manual process is that it’s cumbersome,” Reinhardt points out. “So people start to go around it. And that drives poor quality management.”

In contrast, he says, “you can leverage a digital solution to drive a quality mindset throughout your company’s culture.”

For example, if supervisors can electroni-cally track who has gone through training, they will. If production managers have access to quality metrics, they’ll use them. Quality then becomes part of every employee’s daily activities and approach to work. In this way, quality management can drive business suc-

cess.“Many compa-

nies think they need to comply with regulations on the one hand but grow the busi-ness on the other hand,” Reinhardt says. “They be-lieve that the

more they think about compliance, the less they can think about the business. But it’s not either-or. Compliance enables your busi-ness. Quality is your business.”

In the past it was a business truism that companies could attain only two of three at-tributes: quality, speed and cost. A company could be high-quality and fast, but expen-sive. Or it could be high-quality and cheap, but slow. Or it could be fast and cheap, but low-quality.

“Today we have the tools to achieve all three at once,” Butler believes. “If you focus on quality, you’ll be both fast and cost-effec-tive. Because you’ll do it right the first time.

“You can leverage a digital solution to drive a quality mindset

throughout your company’s culture.”

—Tim Reinhardt, Senior Consultant, RMC Pharmaceutical Solutions



And it takes a lot of time and expense to fix a quality problem after it occurs.”

“Quality assurance isn’t there to make your life difficult,” Morris concludes. “It’s there to protect your business. And investing in digitized quality management” – along with intelligent quality maturity – “is an im-portant step toward business success.”

References: 1. “Data Integrity and Compliance With Drug CGMP,” FDA, December 2018

2. “Quality 4.0 in Pharmaceutical: Learn From the Innovators,” LNS Re-

search, 2018

3. “Digitization in Life Sciences,” KPMG, 2018

4. “How to Select a Quality 4.0 Solution,” LNS Research, 2018

5. “How to Select a Quality 4.0 Solution,” LNS Research, 2018

“If you focus on quality, you’ll be both fast and cost-effective. Because you’ll do it right the first time.”

—Mike Butler, Founder and CEO, Unit Life Sciences

The Journey to Intelligent Quailty

Box-checking mindset Quality and compliance embedded in the culture

Under-resourced Shared quality responsibility across the business

Manual documents Automated processes for document management, CAPAs, training and change control

Mismatched, poorly designed processes

Automated, accurate processes and workflows

Painful inquiries and audits Faster and easier inquiries and audits

At-risk patients Patients benefitting from higher-quality products and services

An at-risk business Business growth enabled by risk mitigation, efficiency and confidence

© Copyright 2019 ZenQMS. All rights reserved.

www.zenqms.com

About ZenQMS

ZenQMS enhances the quality compliance profiles of life sciences companies via a cloud-based platform, purpose-built to manage document collaboration and control, training, issues, change management, and audits with ease. The ZenQMS team is comprised of both technology and quality leaders with the shared mission of elevating quality management to be a business imperative.

http://www.zenqms.com

Intelligent Quality Maturity: Driving Business Success

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