Can Our Current Operational Processes Survive In 2025 And Beyond?

By Tobias Hitziger, MAIN5

If life sciences organizations are to maximize their market opportunity and remain commercially viable amid intensifying cost pressures, the squeeze on pricing and margins, stiff global competition, and increased product sophistication/complexity, they must step up their efforts to make their operational processes as efficient as possible. That could be the way regulatory submissions or safety reports are created, verified, and quality controlled internally, for instance.

Yet, today, across pharma regulatory affairs, quality, and pharmacovigilance/drug safety functions, process rigor is wedded tightly to standard operating procedures (SOPs) — exhaustively documented step-by-step descriptions of how things are done — to ensure a standardized way of working. Those SOPs are in most cases PDF versions of Word files, managed in an electronic document management system to ensure compliance. These snapshot definitions of the way things are done do not, of themselves, foster efficiency or effectiveness, however.

Looking Up A Level

Even where essential, routine processes are improved and optimized over time, and as long as these improvements are confined to a single function or sub-area, the benefits will be limited to that context. Problems commonly arise at points of handover, e.g., between teams working in the same department or as workloads pass between different functions (or out to a service provider and then back again). If the interfaces inhibit seamless continuity or clear visibility, momentum may be lost.

Where companies take a more holistic view that places the focus on the output of processes and the goals they are designed to serve, multiple gains can be achieved. These range from true improvements to overall efficiency, as well as new clarity about roles and requirements within each process. These developments, in turn, can inform new IT systems implementation (e.g., more sophisticated regulatory information management systems or AI-enabled content creation aids), as well as outsourcing arrangements — ensuring that these deliver maximum value. It makes good business sense, then, to review and optimize processes on a broader scale.

Fuller process transformation requires a more extensive review of what is going on, on an end-to-end basis. Without that, the potential benefits will always be compromised.

Barriers To Bigger Ambitions

So why hasn’t more progress been made, given the scope for holistic process improvement? What is holding back pharma R&D organizations from being bolder and more innovative in their process transformation?

Culturally, some reservations are linked to an instinctive fear of extended transparency, especially during inspections. Where processes are viewed, treated, and managed more holistically and continuously across the traditional boundaries or departmental divides in a process management suite, there may be concern that inspectors might extend their curiosity and raise their gaze when reviewing current procedures. This concern is heightened where companies use business process management (BPM) suites to represent their entire process landscape within a single system (with the risk that inspectors can freely roam from one process to another). Yet, if processes have been well-defined and are running smoothly, in a closely tracked way, the ability to see all of this at a glance is a positive development.

More practically, it is the lack of clear process definition (beyond the scope of individual SOPs) that is the greater sticking point. It is only when process owners and process “customers” (those on the receiving end of the output) agree on what a good process looks like that this knowledge can be applied effectively to streamline it. This is because, in many cases, there has been a loss of sight of the deliverables of processes and who and what they are designed to serve — beyond inspectors’ satisfaction that no corners are being cut and that procedure repeatability is ensuring the highest standards of quality, safety, and regulatory compliance of a created output. If the output is ultimately wrong, for instance, any gains in “throwing it over the wall” more swiftly will be lost. If the output is a document (e.g., part of a regulatory dossier) that fails to meet the requirements, it will be sent back to the author, creating a costly and timely rework cycle.

Another common fear of investing in real process change is linked to concerns about the likely resources this will consume (both financial and in terms of people’s time), potentially detracting from business as usual. As long as process reviews and transformation plans are designed for and adapted to the particular needs of the organization, the justification for the improvements become clear and these barriers to change are soon brought down.

Going Deeper

True process improvement, especially end-to-end transformation across an extended environment, needs to start with clear, ideally in-person communication between the main parties involved: the process owner (the person who leads and is responsible for the process), process participants (anyone involved in delivery), and the process customer (who needs the output for their own next purposes). The goal of this should be to identify the most efficient process to create the output as expected by the customer leveraging experiences where repeated issues emerged in the past (e.g., repeated pushback if something is wrong or incomplete and the ensuing rework cycles).

Alongside, or to help provide a focus for, discussions about scope for process improvements, process stakeholders can harness intelligent “process mining” tools to analyze where productivity issues more commonly occur and identify common bottlenecks and repeat loops.

The greater the scope of the process elaboration (where processes are broken down and articulated in detail, for the purposes of review and improvement) and the broader the range of stakeholders, the greater the timescale needed to evaluate, redesign, and optimize the new agreed scenario.

Again, staying focused on the common goals will be important, such as improved and more effortless compliance; greater clarity for all parties about what is needed, when and why; and the scope to alleviate resource pressures through the targeted automation of labor-intensive tasks using appropriate technology (e.g., modern RIM capabilities).

Streamlined, Aligned Processes Yield Multiple Benefits

Once good, streamlined, and aligned processes are in place, teams can pull this content and create SOPs. Clear definition of process roles (“swim lanes”), meanwhile, can help identify the specific activities linked to them. This in turn could be used to inform role-based training for the individuals fulfilling the processes.

Ultimately, good process elaboration, oriented toward the process customer, enables greater operational efficiency. It also makes it much easier to introduce new technology systems and features, since well-described processes inherently force robust descriptions of user requirements. No business ever suffered from having a better understanding of its end-to-end processes, after all. On the other hand, where a lack of clarity persists on how process output and any efficiencies gained will be harnessed by adjacent teams or functions, the scope for real transformation will continue to be compromised.

About The Author:

Tobias Hitziger is a management consultant at MAIN5, with over 15 years of experience in the pharmaceutical industry, and he heads the firm’s process team. As an expert in business process management within pharma R&D, he specializes in organizational change, lean business transformations, and senior management coaching, with a focus on optimizing operations and driving efficiency in global regulatory affairs. He can be reached at tobias.hitziger@main5.de.