Digitizing CMC Knowledge Management
By Irwin Hirsh, Q-Specialists AB
Going digital to achieve its promise is a worthwhile effort but is certainly not without its risks.
The larger and more comprehensive the digital system, say ERP or MES, the greater the risk of wasting the resources1 required for implementation as well as the fees for the software and/or hardware.
A Glance Back Before We Proceed
The first article of this series presented the business case for knowledge management (KM). The second article presented mapping methodology for identifying and organizing critical process knowledge.
This article, the third in the series, presents a strategy for the digitization of that knowledge. As with all articles in this four-part series, examples from quality risk management (QRM) and biologics process development (CMC development) are presented. Regardless of the context, I maintain that the approach to KM presented is directly applicable to any process or system of processes.
Start Small
For the purposes of KM within CMC development, we can enjoy significant returns with specific SaaS solutions designed specifically to manage the knowledge of our processes.
With my clients, I use three SaaS tools:
- ValGenesis iRISK to manage the knowledge of quality risks, which we’ll talk about later,
- PRESTO to manage the processes and projects of the business, which I demo in a video below, and
- DOT Compliance, a QMS software with an in-built electronic batch record (EBR).
In the spirit of transparency, I’ll note that I receive a fee when my clients buy licenses for these programs; however, I receive nothing if you simply feel inspired after reading this article and go buy them for your own operation. There are, of course, alternatives, and I will mention some here.
Manage Change
Digitization of process knowledge requires that your company culture demonstrably values process knowledge and that senior leadership is actively engaged in the process orientation efforts. Digitizing and automating process knowledge is not just about streamlining operations, it's about empowering teams with readily accessible knowledge and enhancing know-how retention. Those who continue to challenge this often do so out of ignorance about the true value-add of having intellectual property readily available to their team. Alternatively, it can be driven by fear that changes will not be accepted by management and the rank and file.
To make a specific business case for a digital tool, one needs to prove to those holding the budget that the tools are desirable and compliant with the business demands technically and a good fit culturally.
The business case for KM in CMC development was made in the first article.
Leveraging Existing Tools To Overcome Resistance
Many enterprise software programs come with workflow management tools and one can likely leverage an existing platform to create the proof of concept for submission along with the business plan.
The Microsoft environment seems ubiquitous in the enterprise space. If your company runs Microsoft 365, there is a fine collection of workflow automation tools available. Many of these can be cobbled together into a bespoke tool that adds value. Creation of these workflows and their interfaces require skills that, if not present, can be learned through YouTube videos and online manuals. Alternatively, custom Microsoft 365 builds can be contracted.
Other large enterprise software systems often come with workflows specific to their use case. For example, Veeva Systems is commonly used for running company QMS and, as such, is well-situated to handle document workflows.
Nevertheless, the end goal is knowledge management, not just workflow management. However, the small wins with existing software will require many of the same process mapping tools used in KM to be successful. This introduction to knowledge collection and then deployment for improved productivity can be an excellent start.
Pre-Digitization Preparations
Once you have gained traction and the mandate to purchase a focused piece of software for supporting your area’s critical processes, a significant effort must be made to capture critical process knowledge. A poorly understood or functioning process will simply fail faster in a digital realm. The following video provides an example of the pre-digitization work required for success in managing the knowledge around quality risk in CMC development.
Sourcing your software for your specific purposes always helps in controlling your most critical processes. However, as you can see from your swim lanes mappings, the more important a process, the more it is connected to other processes and other areas of your business.
Within CMC development, QRM is fundamental to productivity. However, QRM processes are fundamental to science- and risk-based decision-making across the pharma value chain. Therefore, setting up a QRM tool for development, in principle, should later become a value-adding knowledge management tool for the entire company.
Once the entity leaves development and the QRM tool enters the manufacturing facility, ideally by facilitating a flawless technical transfer, the engineering group can utilize it for their needs by building on the process knowledge. This could be, for example, determining mean time to failure risks (to the business and the patient) and thus developing a patient safety-centric preventative maintenance schedule.
Digitizing The Business Of Development
Above, we discussed how tranversal QRM is in the business. A digital tool like iRISK can be used systematically across the value chain for sharing critical knowledge related to risks so that it is available for use when needed. The knowledge bank grows as new knowledge enters the organization and/or knowledge gaps are identified. The same is true about some other facets of CMC development. Let us look at one more.
Electronic batch records
Electronic batch records (EBR) for development batches add value not only to development but to future GMP batches for clinical or on-market. Imagine the relative ease at which the goldmine of process knowledge can be mined from such records compared to the painstakingly slow and inaccurate method of transferring paper records to Excel! Suddenly there is a straightforward path for using batch records to find cause-and-effect relationships between equipment changes, methodology, and raw materials on product attributes. Analyses are now possible at a higher level of resolution. This, together with good design of experiments (DOE), will reduce the number of subsequent experiments and accelerate time to market.
EBR data in a database would enable not only a clearer picture of the current run data but could potentially enable the creation of platform knowledge for document management as well as unit operations. Additionally, the development system need not necessarily be a GxP system as it is common practice to use Microsoft Excel to visualize and analyze development data.
Figure 1 Functionality of DOT EBR
If your company lacks an EBR system, trying it out in CMC development could be a cost-effective pilot to run before going through validation and rollout in the GxP manufacturing environment. Having the same EBR in both environments would enable a common understanding and accelerate tech transfers.
They’re Processes, Not Just Projects
Monday.com, Asana, or the To Do of Microsoft 365 are excellent productivity tools for projects and workflow management. However, as indicated above, projects and workflows are not the fundamental units of a business. By operating and managing on the process level we can ensure that the people deployed to projects are appropriate, informed as required, and aware of their responsibilities and how to perform them. When our processes are under control they can be managed together as a system to achieve common goals.
If we take care of the processes of the business (proactively working “on the business”), projects will run smoother and more predictably. Failures and issue management (reactively working “in the business”) will kill productivity, growth, and staff engagement.
The following video provides an overview of how a process knowledge management system can, when populated with process details, connect the business from goals to roles.
Be Sensitive Of Company Culture
Digitization efforts will fail to bring positive benefits to the company without a culture that encourages its implementation, use, and continuous improvement.
Try to mitigate any of the potentially negative impacts of the change, real or imagined. Sometimes this can be as simple as waiting for the events to transpire before launching significant changes to the culture.
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About the Author:
Irwin Hirsh has nearly 30 years of pharma experience with a background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. In 2008, Irwin joined Novo Nordisk, focusing on quality roles and spearheading initiatives related to QRM and life cycle approaches to validation. Subsequently, he transitioned to the Merck (DE) Healthcare division, where he held director roles within the biosimilars and biopharma business units. In 2018, he became a consultant concentrating on enhancing business efficiency and effectiveness. His primary focus involves building process-oriented systems within CMC and quality departments along with implementing digital tools for knowledge management and sharing.