Pfizer is one of the largest pharmaceutical firms in the world, most recently recognized for the development of the COVID-19 vaccine that gained FDA authorization for emergency use.
When creating a drug, there are three main objectives: is it safe, is it effective, and is it of good quality. For the quality aspect, there are numerous iterations and documents required for validation by the FDA. Reports are created for analysis on all clinical data, test results, safety reports, compliance documents and more. Handling such copious amounts of data and documentation is time consuming and poses a potential threat to data inaccuracies or inconsistent reporting.
The current drug review process spent a considerable amount of time collecting and extracting data as well as maintaining report hygiene. These regulatory reports require manually aggregated data from disparate systems, causing a delay in the validation process. Now, more than ever, Pfizer needed to eliminate time-squandering manual efforts and ensure zero data entry errors to submit correct and accurate reports for approval.
Pfizer’s drug testing and review processes relied on data from databases spreadsheets and various other applications such as LIMS (Laboratory Information Management System) to collect clinical data and test results. The current process resulted in long validation timelines involving multiple people and multiple reviews to verify the reports are correct and more importantly accurate.
PSC Group helped Pfizer maintain the integrity of clinical data reports by creating Winward templates to automate the process of creating, generating, and maintaining scientific quality-centric reports.
A master template needed to be built out to dynamically import the data and use conditional logic to properly display and format the information for business specific needs.
This was a true team effort where we worked closely with Pfizer and resources to start from a prototype of a concept and take it all the way through to a production solution.
Pfizer brought in PSC Group to implement an automated document generation solution that sped up the time to produce reports and reduced the overall footprint of report maintenance. The best possible solution would address the following issues:
By creating Winward templates, PSC Group helped Pfizer improve efficiencies and reporting processes. Automating the process of generating reports and documents reduced the risk of human error while establishing a system that enabled Pfizer to free up resources and speed up approval processes. Together, we reviewed the templates and reporting platform to deliver a solution that enabled Pfizer to better serve the public in times of need.
PSC Group took a streamlined approach to these reporting requirements and worked closely with Pfizer to build out an automation strategy using Winward templates.
PSC Group’s automation efforts proved to be successful across many different validation, qualification, and stability control reports…and this is only the start. More and more divisions within Pfizer will be using the centralized reporting platform and inevitably move to automate the numerous mandated regulatory reports required for approval and improve the overall time to market compared to today.