The Pharmaceutical sector has been working to control rising costs in an environment of increasing regulatory control and testing. Today, many pharmaceutical processes are still people- intensive and require high volumes of staff to toggle between multiple systems and screens to achieve “last-mile” integration, but what if there was a better way?
Since pharmaceutical manufacturers, researchers and consultants typically apply standard and consistent rules to nearly every process, these repeatable and consistent processes are prime candidates for RPA.
RPA is a very simple form of automation that can take processes which are:
- Rules based
- Involve very simple if/then logic
- High in volume but low in value
By automating these very basic tasks, pharmaceutical organisations can release high value staff from the mundane tasks.
Proservartner can help not only by implementing new technology but using our change management methodology to ensure a smooth transition for your team.
Processes ripe for automation
It’s estimated that large pharmaceutical companies process between 500-700,000 adverse event cases each year and that the processing of these cases equates to around half of output from Pharmacovigilance teams. These cases often come from a variety of different systems and the data varies in quality, structure and format. The adoption of RPA can reduce human error, ensure a standardisation of process and significantly reduce processing time. A bot can collate information into a central ERP, and through use of parameters analyse key words and related health factors such as age and underlying conditions to prioritise which cases are more likely to be classed as AE. By automating manual steps a pharmaceutical company significantly lowers their compliance risk with the potential for significant savings.
Regulatory submissions are both time and labour-intensive, requiring organisations to carry out activities that include tracking the status of documents and compiling records to create a dossier. Automation technologies such as Optical Character Recognition (OCR) can be easily implemented with RPA to increase efficiency. This would allow for PDF documents to be read, the relevant information extracted and then used to complete various reports and submissions. This can significantly reduce process time enabling a faster route to market.
Many pharmaceutical organisations are dependant on quick access to the right technical knowledge in order to resolve issues faster and collaborate better. Without timely access to the right knowledge, schedule delays and resource costs can quickly escalate into significant losses. Correctly collecting and tagging this information would be a huge manual task, but RPA can search through multiple SharePoint sites and file shares, sitting on different systems. It can then associate content that belonged with a particular development product, classify it against a predefined set of taxonomy and business rules and ultimately process it onto a knowledge platform, where it could be easily found by staff.
Proservartner worked alongside a busy law firm who had thousands of Property lOT records they needed to manually copy from their Microsoft Access Database to a Cloud based Environment.Read our case study
“There are two key factors that will drive automation for pharma. The first is that regulatory pressure is only increasing with a clear emphasis on the speed of reaction. The second is that the sheer amount of data has grown tenfold in a short amount of time and is simply unmanageable by humans if it is to be used effectively.
Regulation is both a prime motivator and prime obstacle in the automation of pharmaceutical processes. On the one hand using automation to fulfil regulatory compliances can save a firm significant amount of time and reduce costs, but on the other hand in a regulated environment, any system that performs a decision-making function requires validation and solid change control.
Specifically, any change requires re-validation to show that the system either interprets the input correctly and correctly executes the expected resulting action, or flags the transaction for human intervention. To date, we’ve not observed a pharmaceutical firm or a contract resource apply RPA to manage validation, and firms continue to rely on people to perform this function.
However, because RPA systems are precisely configured and audit-able and are specifically designed to not “colour outside the lines,” they have the potential to effectively address the validation challenge, and in fact could do so in a more reliable and accurate manner than humans.”