Pharmaceutical companies are required to submit a comprehensive Annual Product Review (APR in the U.S.) or Product Quality Review (PQR in Europe) to government health authorities annually, detailing key aspects of the manufacturing process for each drug they produce. This is a long-drawn, laborious and manual process, prone to errors. In other words, an area practically begging for automation of the process.
This is not an easy task. But though the journey can be complex, I think the following steps will lead to a successful APR-PQR automation:
- Design the Core Business Process: All the reporting processes in all the plants in every geography must be synthesized and harmonized to establish a single, standard process that has acceptance from all future users of the automated solution. It will be useful to map business designations to application roles at each site to help site representatives understand their roles in the automated solution and give them a chance to air their concerns for day-to-day usage, if they have any, before the solution goes live.
- Define a Global Template: It is important to create a standard, global report template that aligns with the technology used to draw the data. The template should include standard reporting tables in each report chapter, along with any critical information to be captured.
- Identify Data Requirements: The source system of data fields for the reports should be defined, the data fields identified and documented in understandable language. Subject matter experts should confer and decide which data field in the ERP should be used for reports.
- Finalize Data Transformation Logic: Arrive at a single "logic" based on best-in-class data transformation practices to guarantee successful implementation that isn't subject to individual interpretations.
- Conceptualize the Solution: This is one of the most important and complex steps to an automated solution. The solution must be conceptualized based on the business and technology architecture. This can be broken down into three primary GxP-relevant components: business process automation, data transformation module, and integration with different source systems and a statistical analysis tool.
- Plan for Phased Implementation: Depending on the organization's priorities and budget, it can be done as a single, complete implementation or in phases through pilot projects. I recommend that given the scope of the change at multiple sites, going step by step is the best approach as a way to control each phase and manage user expectations.
I agree that this is a complex transformation that appears challenging to implement. But, addressing it one piece at a time with proper planning and established priorities will gradually turn a once onerous, inconsistent reporting process into just another annual task that the reporting team can accomplish accurately and with confidence.