One of the biggest challenges faced by pharmaceutical organizations related to regulatory publishing and submissions is the sheer volume of data that must be gathered and analyzed and the short turnaround time to finalize submission ready documents.
Below are the major challenges faced in the industry in Publishing and submission:
- Timeline challenges: Manual creation of BM, HL and document properties page by page is a tedious process which requires huge amount of time. Also, the review of the documents/submissions and rework which may lead to submission delay.
- Compliance to evolving Regulatory Agency guidelines: Another challenge faced by pharmaceutical organizations is the need to comply with multiple regulatory agencies and guidelines. Each agency may have its own unique requirements for submitting data and documentation, and it can be difficult for organizations to keep track of these requirements and ensure compliance.
- Training and licenses for the tools and technologies for resources: Resources should have proper training and knowledge to identify the right version of the document and about the eCTD structure to build the submission. The recurring cost involved in the related tools.
- Manual errors: Manual execution of the work is highly time-consuming and can introduce errors while publishing.
This can include everything from clinical trial data and results to safety and efficacy information. Collecting, organizing, and submitting this data can be a time-consuming and labour-intensive process, and it’s essential that it be done accurately and in a timely manner.
Robotic Process Automation (RPA) can help to address these challenges by automating many of the data-gathering and submission tasks. For example, software robots can be programmed to collect data from multiple sources, such as electronic medical records and clinical trial management systems, and to organize it in a standardized format that is suitable for submission. This can greatly reduce the time and effort required to prepare regulatory submissions, while also ensuring that the data is accurate and complete.
RPA can also help by allowing organizations to standardize and automate their regulatory submission processes. Including eCTD, NeeS and paper formats Software robots can be programmed to avoid manual -intensive, repetitive tasks such as PDF document properties, PDF page properties, bookmarks, and hyperlink creation/properties, document assignment to eCTD folder sections, and to check submissions for compliance within various guidelines and requirements and alert users to errors or discrepancies. This can help organizations to submit accurate and complete documentation and to avoid costly delays or penalties.
Despite its benefits in the life science industry, RPA implementation could pose its own challenges. One of the main concerns is the lack of knowledge and expertise in the field. Many organizations may not have the resources or expertise to design, implement, and maintain RPA systems, which can be complex and require considerable IT support. RPA is not a silver bullet solution and if not implemented properly, a system may fail to meet the desired results.
Moving away from traditional manual publishing activities to automation can bring significant benefits to pharmaceutical organizations in terms of efficiency, cost savings, and compliance.
The main advantage of automation is the ability to automate repetitive, manual tasks such as data entry and formatting. Using Robotic Process Automation software, organizations can automate the process of gathering data from various sources and organizing it in a standardized format for submission. This can greatly reduce the time and effort required to prepare regulatory submissions, while also ensuring that the data is accurate and complete. Other benefits of RPA include:
- RPA help reduce the costs associated with resources required to manage regulatory compliance.
- RPA significantly reduces the risk of human error, improving the accuracy of regulatory compliance data and reporting.
- Regulatory automation offers opportunities to work with cutting-edge technology.
- RPA help ensures that regulatory data is accurate, up-to-date, and easily accessible, improving the quality of regulatory documents/submission.
Finding the accurate technology for regulatory publishing and submissions is crucial for pharmaceutical organizations looking to streamline their processes, lower costs, and achieve ongoing compliance.
The first step in finding the right technology is to conduct a thorough analysis of the organization’s current publishing and submission processes. This can include identifying key tasks that are time-consuming or prone to errors, as well as the specific regulatory requirements that the organization must comply with. This information can help to inform the selection of a technology solution that is tailored to the organization’s specific needs.
One approach to finding the right technology is to evaluate different Robotic Process Automation (RPA) solutions. Many RPA solutions also have built-in compliance and validation capabilities that can help organizations to meet their regulatory requirements.
Another approach is to consider using electronic submission solutions, that are specialized in submitting data and documentation to regulatory agencies and publications. These solutions can offer features such as document management, version control, and submission tracking which can help organizations to keep track of their submissions and ensure compliance.
It’s important to consider the integration of the solution with existing systems, data, and workflows. Therefore, it’s recommended to evaluate the vendor’s experience in integrating their solution with similar systems in the organization, their customer support and maintenance services, and their track record of successful implementation.
When evaluating potential solutions, it’s also important to consider the vendor’s experience and expertise in the life science industry. Organizations should look for vendors that have a deep understanding of the unique challenges and requirements of regulatory publishing and submissions, and that have a track record of successful implementations in the industry.
Finding the accurate technology for regulatory publishing and submissions is crucial for pharmaceutical organizations, and requires a thorough analysis of the organization’s current processes and requirements. Organizations can consider evaluating RPA solutions, or specialized electronic submission solutions, while keeping in mind their integration with existing systems, data and workflows, vendor’s experience and expertise in the industry, and its customer support and maintenance services. It is important to work with vendor that have a deep understanding of the unique challenges and requirements of regulatory publishing and submissions, and that have a track record of successful implementations in the industry.
RPA can assist in standardizing submission processes across different regulatory agencies and guidelines, ensuring compliance and avoiding costly delays or penalties.
The use of software robots eliminates the need for manual data entry, which can be both time-consuming and prone to errors. Additionally, RPA can be programmed to check submissions for compliance with various guidelines and requirements, which can help organizations avoid penalties and fines that may result from non-compliance
Some of the areas where automation can help are
- Word document formatting
- PDF conversion and support creating navigational aids
- End to end processing of 1572 submissions
- End to end processing of AdPromo submissions
- End to end processing of Adverse Events submissions
- Quality review process
- Translation of the regulatory documents
- Dossier import and archival of the dossier and acknowledgment receipts.
It’s important to note that achieving these benefits by using RPA, requires proper planning and execution of implementation. Organizations should consult with experts and conduct a thorough analysis of their current processes and requirements before implementation. Additionally, it is important to have a dedicated and highly skilled resources in charge of maintaining and updating the robust RPA system to ensure that it continues to meet the organization’s needs and remain in compliance.
Below are the some of the important points for implementing Regulatory Automation
- Resources and Skills: The implementation of automation requires specialized skills and resources; Organizations must ensure they have the right resources and skills in place to support the RPA.
- Technology Requirements: For successful implementation of automation implementation the organizations need to carefully evaluate their technology requirements, including hardware, software, and networking infrastructure, Considering the evaluation of potential vendor solutions and the selection of the most appropriate technology also an added advantage.
- Data Management: A robust data management system in place to ensure the accuracy and security of the data being used for automation is very highly recommended. This may include data validation, data quality checks and data security measures.
- Change Management: Organizations need to have a well-defined change management plan in place to ensure a smooth transition and minimize disruption to ongoing operations. This may include communication and training plans, as well as the development of clear policies and procedures.