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Patricia Santos-Serrao

FDA Compliance

How Pharma Quality Leaders Navigate Shifts and Instigate Change

Four pharma quality trends

Published: Monday, August 1, 2022 - 12:02

The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.

They are also being driven by extensive shifts in emergent digital technologies, a need for deep predictive data insights, and a cultural demand for personal and system connectivity. Add to this list a shifting regulatory environment with an increased focus on personal responsibility for auditing and risk management. New opportunities and responsibilities can seem overwhelming.

However, the bright side of assuming personal responsibility is the self-determination it allows. Businesses that make innovative changes amidst upheavals and downturns actually gain momentum and outperform competitors upon recovery. What sets apart thriving pharma businesses is their willingness to spot the market shifts as they begin to crest, pivot to align with them, and then swim through deep waters to ultimately catch and ride the wave. Their adaptive autonomy allows them to absorb disruptions and modify in company-specific ways to move through them. 

There are four industry trends worth exploring that demonstrate the flexibility of pharma quality leaders. Included here are some practical tips for companies to align with and capitalize on these trends.

1. Risk management expectations continue to evolve

Recently, even well-established companies, such as General Mills, Daily Harvest, and Abbot, have proven vulnerable when risk-management strategies are inadequate or unable to answer to public concerns. The complexity of pharmaceutical companies seems to make them particularly sensitive to social and economic turbulence, which can directly affect operations along the product life cycle as well as all of the people and partnerships involved. The U.S. Food and Drug Administration (FDA) itself is highly sensitive to these dependencies and is placing greater emphasis on high-risk approaches to quality, tasking companies with greater responsibility to mitigate risk. This makes it imperative for companies to have ways of identifying areas of highest risk and prioritizing mitigation tasks.

The trend
The ways that quality leaders are answering the imperative is to implement data-driven solutions that allow them to manage more frequent and more severe risks. In doing so, they are also preparing for the greater degree of self-regulation that the FDA is fostering.

The tips
• Engage in collaborative dialogue with regulators about proposed changes. Because risk management varies greatly from one organization to another, it’s important to analyze the risks that are unique to your organization and the ways you plan to mitigate them. Discussing your plans with regulators can alleviate concerns about your proposed changes or help you to refine them.
• Update legacy systems to automate and streamline risk management across your enterprise. Outdated paper-based processes are not dynamic enough to match current trends. Digitized and connected quality systems can provide real-time visibility and tracking that alert you to higher risks, facilitate compliance, get you to market sooner, and reduce costs. 
• Deepen data analytics that foster predictive insights. Risk management is a futures game of anticipating problems and trying to prevent them before they materialize. You need tools with timely access to aggregated data to catch a problem in the making before it gets out of hand. 

2. Quality compliance success hinges on access to good data 

Quality systems, processes, and personnel are directly affected by the data they have to work with. Tapping into your data and making sure they are accurate and available along the line forms the basis of intelligent quality and compliance. Deloitte reports that “data-sharing platforms should facilitate trust among those who are collaborating—so that data are available, accurate, secure, easy to use, and are used appropriately,” and further that “data are the lifeblood of digital transformation.”

The trend
Inspectors look for good data. According to the FDA’s 2021 list of 483 observations, inspectors are looking closely to find complete, accurate, and verified quality and production records. However, they are citing a number of deficient records, processes, and reviews as well as difficulties locating and controlling these records. These discrepancies suggest a warranted prioritization of digital records and systems. Digitized records can provide and contextualize the data necessary to achieve and show compliance measures. They can also reveal room for improvement. Accenture refers to this as establishing a data-centric culture.

The tips
• Unify your data within a common platform. Single-system integrity reduces data silos and allows each area of your organization to connect with one another and align with a common foundation. Technological integrity supports cultural integrity, and both amplify productivity.
• Identify error-prone and redundant processes. Once you have ongoing access to useful data, you can use them to optimize your quality processes. Identify areas where you can automate repetitive processes.
• Leverage a purpose-built tool. Modern quality management systems are designed to structure, analyze, and validate pertinent data. They can also automate many processes. Continued reliance on manual systems reduces accuracy by 9 percent, according to McKinsey.

3. AI is a critical quality optimization tool 

There is a temptation to talk about artificial intelligence (AI) as if it isn’t here yet. However, Deloitte’s 2022 Life Sciences Digital Innovation Survey found that one-third of “survey respondents reported using AI in day-to-day operations, and 31 percent have been part of a project that leveraged this technology.”  According to Columbia University, “machine learning is a pathway to artificial intelligence.... By incorporating AI and machine learning into their systems and strategic plans, leaders can understand and act on data-driven insights with greater speed and efficiency.”

The trend
If we’re learning anything, it’s that this one’s here to stay. Expect to see more companies not only automating processes by building logic into them but embedding AI wherever possible to reduce human errors and extend predictive insights. Using intelligent technologies, systems can interpret data and learn from existing processes to improve and modify them, and prevent problems before they occur. This allows companies to maximize huge data sets that they haven’t been able to use and integrate them with third-party, real-world data (RWD) sources. AI will play an essential part in automated risk resolution, as well as provide a defense against increasingly sophisticated cyber threats. 

The tips
• Approach AI as an enterprise solution. Coordinating between different operational functions, implementing a governance structure, and prioritizing business needs will allow you to standardize your processes and eliminate old data silos, which can undermine the power of any intelligent technology.
• Make sure your data are solid. Not only does the FDA expect your data to be reliable, accurate, and secure according to their data-integrity guidance, but they also form the basis of any intelligent technology. AI taps into previously unused deep data and often exposes poor-quality data. A digital solution can help you “clean” your error-prone data with automation and preconfigured thresholds.
• Unlock the power of predictive analytics to meet business objectives. Choose an AI capability that can provide instant access to data that can be used to drive your current and future business priorities. Align AI capabilities with objectives and implement them judiciously across your organization.

4. Streamlined quality event management drives efficiency

Putting all the trends together points to the necessity of efficient, modern, and comprehensive quality event management (QEM). Quality managers face the everyday overwhelm of tracking events across an entire organization in real-time, assessing how events overlap with other operations, as well as evaluating and mitigating risk when necessary. The cumulative demand makes it tempting to rely on corrective and preventive actions (CAPA). However, this leads to the greater risk of CAPA overwhelm and a stagnant system.

The trend
Trends, traditions, and turbulence are all pushing quality leaders to find automated and intelligent solutions to manage as many quality events as possible, as efficiently as possible. Their method is to use efficient digital tools that can integrate quality directly into manufacturing processes and other areas. In this way, quality no longer acts as the brakes of an organization. Instead, it’s becoming a business accelerator that keeps quality events in motion toward resolution rather than referral. The value of leveraging good data here can’t be overemphasized. According to Sue Marchant, a senior vice president who oversees analytics and data initiatives at MasterControl, “When connected to accurate and up-to-date data sources, such solutions can handle the lion’s share of decision-making.”

The tips
• Standardize and share CAPA protocols. Keep relevant personnel on track by making CAPA-related information increasingly available. Share information on a common platform, preferably a cloud-based system. This allows quality to connect with typically independent functions, such as training and manufacturing, and to make risk resolution a priority across the board. 
• Follow a “step-and-scale” model to make QEM improvements. Build on continuous real-time data to inform your digital transformation priorities and determine which steps you can take first to improve your system. With each improvement, reassess and continue to scale your efforts to achieve your required business outcomes. An enterprise solution that allows for modular implementation can assist you here.
• Adopt a purpose-built QEM solution. A configurable solution with compliance measures built-in will allow you to match attention and resources to the severity of each event. The QEM solution can respond according to predefined thresholds. A cloud-based platform is imperative for remote collaboration and timely reviews with electronic signatures.

The benefits of flexible quality management are measurable

The FDA’s stance on quality flexibility opens the door to a variety of approaches to quality that can support your unique processes, products, and customers. The trends show that the most advantageous angle of flexibility lies in a company’s ability to innovate with digital technology. Futurist Anders Sormann-Nilsson writes it this way, “Adapt or fade into irrelevance.”

McKinsey research reveals that companies with advanced digital capabilities across assets, operations, and workforces grow market shares and revenue faster than competitors. One global pharma company freed 30 percent of quality resources by integrating analytics with core risk-management processes. Others have been able to reduce investigation cycle times for deviations and nonconformances by 90 percent. These types of efficiencies are made possible only by mindfully implementing enterprise and emergent digital solutions. 

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About The Author

Patricia Santos-Serrao’s picture

Patricia Santos-Serrao

Patricia Santos-Serrao is the director of product management at MasterControl.