Risk-based approach driving manufacturing improvements: Cognizant

“Digital transformation” is a phrase heard more and more frequently at nearly every level of life-science operations. Kenneth Teo, a director with Cognizant, connected with Outsourcing-Pharma to explain how industry professionals are rethinking their approach to digital information, document handling, and other tasks to yield better results.

OSP: Could you please share an overview of how the way pharma operations’ methods of approaching digital info and document handling have evolved in recent years?​

KT: Over the years, there has been an evolution in the way data is perceived and used in pharmaceutical manufacturing. For most of its history, pharma’s approach to data and information management was geared to safeguarding intellectual property (IP) and keeping it safe within the enterprise’s proprietary data systems.

Pharma’s very traditional business model was centered on developing and capitalizing on their IP and keeping it within the enterprise – but over the years there has been a shift in the industry’s approach to data as well as how it is processed, secured, and leveraged.

Pharmaceutical manufacturers’ view of data and their approaches to handling it are becoming much more holistic. The recent pandemic opened the industry’s eyes. All of a sudden, many of pharma’s traditional commercial practices (which often involve in-person visits and wet signatures on paper) were locked down. Suddenly it was necessary to integrate new digital ways of working into all aspects of business and operations.

Although the pharma industry has been working diligently on digitizing operations for decades, their efforts at adopting and integrating digital technologies across their operations have not been uniformly successful. While other technology-intensive industries like automotive or semiconductors have been leveraging digital technologies effectively for years, the legacy of pharma’s laboratory roots has slowed its uptake and wholesale adoption.

With the advent of the cloud and a broader range of reliable connectable digital technologies and systems, pharma’s eyes are really beginning to open regarding organizing and launching their digital journey. For most of the industry’s remaining skeptics, the pandemic has provided a real catalyst, sparking a new dialogue with technology vendors and data management consultants about two things: How to start and where to start smarter​.

Now the inquiries are: ‘How can we leverage artificial intelligence (AI) and machine learning to improve quality? How can we leverage supply chain data for better product security?’ It’s also becoming a much more strategic conversation involving teams from all across the enterprise.

All data generated operationally has intrinsic value, but if it can’t be collected, analyzed, and shared across the organization and all trading partners efficiently, its value to the enterprise is essentially zero. Siloed information and data in closed paper-based systems can’t be connected and shared and -- for pharma’s emerging global business models -- that paradigm is no longer sustainable.

OSP: What are some of the key considerations in managing such systems (i.e. safety, efficiency, security, etc.)?​

KT: Managing extremely valuable pharma IP, business information, and operating data effectively will always be challenging. What sets contemporary digital system management apart from traditional paper-based approaches is that digital systems can automatically deliver compliance data without human intervention. Under industry current Good Manufacturing Practice (cGMP) guidance, pharma’s data systems all have to be validated to be compliant—when there are no human processes to inject error, regulators have a much easier time accepting digitally generated data.

OSP: In terms of computerization/digitization and automation, where is the industry now—are we mostly changed over to advanced systems, or are some operations yet to jump on board?​

KT: In general pharma’s journey to industry 4.0 has not been linear and for certain organizations, it has been extremely tough to accomplish – even with the best help, buy-in from the top, and ample budgets. Although some of these failed efforts and false starts resulted from entrenched pharma operational and business models (as well as legacy digital systems acquired over years of mergers and acquisitions), the industry’s mixed results so far rest to a certain degree on poorly executed implementations marred by a lack of vision and strategic positioning of the initiative relative to the greater enterprise.

OSP: If pharma operations fail to bring on digitized and automated systems, what benefits are they leaving on the table?​

KT: It’s clear, post-pandemic, that any pharmaceutical enterprise that doesn’t digitize its operations holistically and engage its trading partners more virtually will likely be leaving everything​ on the table, especially business continuity and profitability. In short, they leave themselves exposed to risk and business uncertainty. In the new world we live in, digital ways of working and statistically analyzed and controlled systems will be the only path forward for pharma.

OSP: What kinds of capital investments are involved?​

KT: Fortunately, with advances in digital and analytical technology, as well as the advent of interoperable cloud-based business applications and network capabilities, cost curves are now beginning to bend down – not up. Capital investment is lower and return on investment (ROI) is faster with the technologies now available. Long gone are the days of trying to knit together information and data systems across the enterprise with expensive and custom proprietary solutions.

OSP: Can you talk about computer system validation and compliance, and why this is important?​

KT: Virtually every operational aspect involved in making pharmaceuticals, including each link in the lengthening global supply chain, is regulated for quality and safety. This includes validating computer system capabilities and demonstrating to regulators that system performance and data integrity support cGMP. This means every FDA or EMA-regulated life science and pharmaceutical manufacturing organization must validate all computerized systems that influence the quality of drug products.

Falling under quality systems management (QSM), computer system validation (CSV) has had a place in pharma’s quality and safety compliance portfolio for years. But, because of the pervasiveness of computer systems across the full spectrum of business and operations, CSV compliance has grown cumbersome and costly, leaving cGMP compliant facilities spending more time documenting and less time testing.

OSP: What’s wrong with the traditional ‘test everything’ approach?​

KT” The life sciences industry’s ‘test everything’ approach to CSV has become outdated, leaving cGMP manufacturing facility operators spending more time documenting than testing. Currently, there is too much of a focus on producing documentation and testing for the sake of testing. Instead, QSM managers should focus on their standard operating procedures (SOPs), as well as how they interact with suppliers and how well they are validating their systems for better CSV quality and performance.

In Cognizant’s experience, traditional CSV methodologies can see manufacturers spending as much as 80% of the time documenting processes, and only 20% of time testing the efficacy of the solutions. For many pharma companies, the expense and resources associated with traditional CSV methodologies are becoming increasingly hard to maintain – especially considering the kinds of QSM approaches and higher standards regulators are looking for in support of better cGMP compliance. These are just some of the reasons why a risk-based approach to validation is growing in popularity.

OSP: Could you please explain what a risk-based approach entails?​

KT: Besides the compelling economic arguments, there is growing interest among pharma’s industry leaders and business developers to introduce ‘true’ risk-based validation. And for good reason – it is becoming understood to be a high-value business strategy that can help to improve performance and reduce costs associated with quality compliance and patient safety. Regulatory agencies in the US and Europe are now urging pharmaceutical companies to accelerate the adoption of risk-based CSV approaches in QSM operations.

Historically, risk-based CSV approaches have focused on functional risk assessments. In the past, countless hours and significant resources were leveraged to assess each function the computerized system provided and then test everything. Instead, pharma’s operational managers should focus QSM validations more closely on relative risk and apply the fundamentals of validation to obtain a better compliance stance in the eyes of regulators.

The extent of validation and the level of documentation detail should be based on risk to support product quality and patient safety. The aim should be to have the critical quality attributes (CQAs) satisfied by the design, with the actual or determined risk to quality and patient safety establishing the additional need for validation.

OSP: What benefits/advantages does such an approach offer?​

KT: Adopting a risk-based approach provides companies with continuous QSM improvement and a financially sustainable way to optimize system performance and cost-efficiency. A risk-based CSV strategy allows pharma companies to constantly scale and add new features. However, implementing such an approach does not come without its own challenges. It is important for the industry to note that when integrating risk-based CSV concepts into QSM they fully encompass their existing processes, practices, and services.