Common Technical Documents or registration dossiers and the associated modules must be created and maintained by every pharmaceutical company. The main focus or concern is to ensure that the dossier, which can be up to several 10,000 pages long, is prepared with the highest quality standards but also with the appropriate efficiency. With increasingly difficult requirements for new registrations and monitoring, combined with the ongoing shortage of skilled personnel, it is often difficult to produce the necessary documents for a large product portfolio in a timely manner.
Similar challenges and problems are faced by our client – a global healthcare & life science company with a broad product portfolio in diverse sectors. The company researches and develops life-changing products in various fields and areas and therefore has the ambition to fulfill regulatory obligations in the best possible way.
The question is: How can this challenge and the workload caused by regulatory dossiers be managed and optimized in the future?
CTDs are used in a wide variety of areas in the pharmaceutical industry. These documents define the functionality, features and benefits of the product or device being developed. In addition, the pharmaceutical quality, safety and efficacy of a drug are determined to be documented in the CTD for drug approval. The fact that the Common Technical Document is recognized worldwide and that it represents agreement on a set format for review and approval in a regulatory sense gives the Common Technical Document a special status. In addition to this, registrants no longer have to modify the information collected to submit it to different authorities. However, since the CTD with its 5 modules is still very time consuming, pharmaceutical companies still struggle with some challenges.
Difficulties for pharmaceutical companies – especially in CTD – are as follows:
lexoro has focused on helping companies & departments accelerate and optimize workflows & work steps in the wake of increasing requirements and challenges in regulatory affairs in regulated industries.
Our lexoro approach: we look for processes or tasks that are currently inefficient and would benefit from simplification or improvement. By restructuring them into automatable parts, we can develop a powerful and user-friendly solution that helps experts with tedious tasks, thus increasing efficiency.
This Intelligent Automation approach, in combination with our focus areas, was successfully deployed & implemented in the project and delivered results that largely resolved the pain points of the employees.
After the initial discussions at the start of the collaboration, it quickly became apparent that automation for the Common Technical Documents in the department would make sense in the form of modular automation sprints.
From lexoro’s focus areas 1 and 3 – „Information & Data Collection“ and „Document Generation & Populating“ – it was possible to develop an optimal concept for the customer in 2 components. The Document Generation Suite for CTD modules.
In the current concept, topics such as preparation, classification and analyses are still handled by employees. With the help of Artificial Intelligence, however, it is also possible to develop and accelerate this in a partially automated way.
lexoro’s approach to automating these processes is based on Robotic Process Automation (RPA) for the first phase. Here, manual & tedious activities are learned and automated by so-called software robots. In this way, all previously manual work steps were automated. Especially the „gathering“ of information from different databases & operating systems and the populating & creation of CTDs. As mentioned before, especially these two workflows are very important and also very time consuming. This realization was the impetus for our customer to become active in these areas and to optimize and accelerate the process through Intelligent Automation.
The solution implementation: Classic automation with Robotic Process Automation – made possible by lexoro’s technology. The solution was developed in the form of a web application that handles the creation of CTD documents completely automatically.
The starting point is the manual selection of the necessary template and its parameters. Here, relevant information and key data are determined, such as the document type to be created and its areas, chapters & sections. Once these basic requirements have been determined, automation can begin. Software robot searches & copies data & information from internal company systems. Subsequently, the data – if necessary – is further processed (e.g. supplementation & trend analysis) and inserted into the template or necessary tables are populated. The focus is always on placing the correct and necessary content in the appropriate section.
But which sources can the technology access in order to use them for generating & populating?
The answer: to pretty much all common available data sources. Whether internal or external databases, other documents in WORD format, operating systems such as SAP, ELN, LIMS, or similar, or tables and EXCEL sheets. Our technology examines, according to previously defined patterns, the sources for relevant information – completely automated. Finally, the document is exported in the desired format and made available for further processing (possibly in a database).
In summary, the lexoro document generation tool exactly meets the customer’s challenges for modules of the CTD. Fast and trouble-free integration of text passages & continuous texts from a previously created database and this automatically into the correct chapters & modules of the CTD. Due to the high flexibility and universal applicability of the CTD tool, more chapters and functions will probably be added to the tool in the future. Here, up to 70% time savings or degree of automation can be achieved. A real gamechanger.
An automation solution was implemented for the customer, which supports & accelerates the time-consuming and tedious CTD process of creation and populating. From the initial information collection & basis of data, to the further provision, to the creation & populating of chapters of the CTD with the relevant text passages.
The complete scope & explanation of the solution with all the supplementary small features would exceed the length of this paper. However, this is exactly what convinced the customer in the initial project phase: the individual lexoro approach, which allowed to integrate almost all wishes and special requirements of the customer in the system.
The first step is a free brainstorming session (teams, zoom, or similar) to discuss the problems, goals and how to proceed. Helpful information in advance: a precise process explanation and possible input & output files or information that will be processed during the process to understand the steps exactly. In the further course, the use case and the application scenario are precisely specified – i.e. which processes and work steps can be automated and which benefits and effects can be generated. This includes use case analysis & customization, an initial effort and cost estimate, and possibly a feasibility study if technical feasibility needs to be demonstrated. The third step is to develop a pilot project. The pilot is the entry into the world of automation and offers first important functionalities that can be fully used in daily operations. Due to a reduced set of features, a pilot can be introduced quickly and thus be used directly by the team for productive work steps.
This stage is also used as a test phase of the pilot with subsequent feedback for further development of the system with any changes for an overall solution.
A so-called Minimum Viable Product (MVP) is characterized by further fine-tuning of features, expansion of requirements and functions, and as preparation for deployment or launch of the solution. The „advanced pilot“ is launched after the initial pilot project.
In step 5, extensive planning for the implementation of an overall solution – the so-called product or solution development – takes place according to the agile „sprint model“. As a general rule, an RPA pilot takes about 4-6 weeks – depending on the scope and complexity. For an extensive solution, as described in this example, about 3-4 months are estimated. Your advantage here: our agile sprint model. We divide our projects into sprints of 2 weeks.
This way you can determine the budget yourself and decide which elements should be automated. Thus, you can implement adjustments and enhancements at any time. You have full control and one thing is certain: within a very short period of time, considerable successes are achieved for both your company and your employees.
Through this flexible and individual approach, we offer our customers the possibility to develop their own product with the exact requirements tailored to them. This is at the same time the decisive factor in today’s regulated landscape. By integrating flexible automation solutions, some challenges in pharmaceutical industry can be addressed. Conventional, out-of-the-box software often doesn’t cover all the requirements you need for complete and compliant data collection or CTD creation. In addition, requirements are constantly changing or becoming more stringent. External expertise is usually only possible in the short term and is often connected with the loss of know-how. Know-how that your employees urgently need when these „outsiders“ or even colleagues leave. These challenges are compounded by the increasing number of manual tasks and the general difficulty of the expert labor market. With lexoro solutions and the combined power of industry experience and automation know-how, you can tackle these challenges and prepare for the future.
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