CMC: Authoring & Publishing Automation – Challenges/Solutions

September 9, 2021 Regulatory Automation

At the high-impact R&D end of life sciences, investment in technology is consciously linked to commercial priorities including innovation, efficiency and speed to market. Here, smart use of technology to accelerate what would otherwise be labor intensive manual processes ensures that CMC/Quality data representation (in form of documents/reports) is robust, bears close scrutiny, and doesn’t tie up more skilled resources than is absolutely necessary.

CMC Authoring is an art of science. Here comes the conflict of automation which is seen as “inhuman”. But as requirements are multiplying every day, how can companies manage the load without increasing resources or resorting to outsourcing or offshoring?

All CMC teams want to spend time on “science” or “innovative projects” and not seen as a ‘cost center’. With these objectives and workload increasing, a case for technology enablement and automation is strong. So, what is holding companies back from investing in Authoring, Publishing & QC automation?

Below are three of the most common perceived barriers to technology-enabled CMC automation, and how and why they should be addressed at the earliest.

1. A lack of “Writing” friendly enterprise solutions

Look at most other industries, especially those that are highly regulated, and use of IT systems tends to be highly evolved. That’s because organizations have long realized the inefficiency (in cost, time and resources) of using people to manually input data into core business systems, and then physically re-enter the information into documents and repeat the duplication in life-cycle or other country specific documents.

In pharma, by contrast, “EDMS” and “Word” are the only and dominant tools provided to Authors. EDMS (whether on premise or cloud) may provide some help like versions, tracking, collaboration, but doesn’t address the bulk of manual heavy lifting that needs in Authoring. Same with WORD in spite of adding some macros.

In some cases, the issue is that CMC departments lack access to relevant technology expertise and knowledge, so they don’t have a picture of what’s available or what’s possible – including the scope for sourcing solutions and optimized business processes via cloud-based platforms and relationships with technology vendors. Meanwhile, larger companies which do have sufficient internal resources often believe that they need to build any tools themselves, something they may never get round to – especially if they haven’t tied down a proper business case & ROI.

Given that some very intuitive and easy-to-integrate Authoring (either Structured or Automated) tools do exist out in the external market, with the precise purpose of assisting in improving writing efficiency, it seems surprising that sponsors do not make more use of them – especially as the time and cost savings associated with digital solutions are shown to exceed 60 per cent when compared with processes that rely on manual writing alone.

2. Cost

For reasons mentioned earlier, Authoring does not tend to attract big budgets. This means that any investment in Writing management IT needs to be tightly targeted, and seen to deliver improved results with greater efficiency. If companies choose not to invest in transforming Writing activity, they risk spending more than they need to, and consuming too much time of busy people who have other more critical tasks to be getting on with.

While large companies, may question the cost/benefit trade-off of creating new automation aids, their internal development is not the only option. Taking advantage of a pre- existing pre-tested tool that’s ready to go today and accessible on demand via a software-as-a-service delivery model, changes the economics considerably – especially if there is no associated support burden, because the vendor takes care of everything.

3. How about Non-core Authoring tasks?

Several research articles and surveys point that the non-core activities like QC, Publishing, Submission-readiness costs companies 25 to 50% of their authoring time of the total time based on the type of documents. You can do the math based on how many CMC documents you are authoring/modifying per month to see the budget spent (and unfortunately in most companies this is not tracked well to see the gravity of this challenge). You can stop or minimize this $$ drain and free up time for your resources.
Technology and tools available that can help CMC Authors minimize this non-core time and automate publishing, validation and QC. In addition to all these, add tracking and other workflow based options on top of these to keep CMC teams more organized and focused.

Why wait?
Looking for discrete tools which are very easy to adopt and use, and which alleviate a substantial manual administrative burden– are a good way for companies to test the potential of CMC automation and amass some experience.

Embracing greater automation is going to be essential as writing/reporting/publishing requirements continue to multiply and grow, placing an ever greater strain on resources. Automation offers a way to cope with rising demand, and to simplify demanding routine tasks, as companies expand their product mix and market coverage, while maintaining regulatory compliance.

Yet, to take full advantage of the opportunities, companies need to overcome their historical barriers to technology adoption – and there is no time like the present with several lessons learned by in this pre and post Covid era.