A long list of data integrity warnings received by pharma companies has made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitization and building a data repository to make it easily available to analyze issues and predict challenges.
However, the current challenge is that digital transformation is going slower than expected, resulting in the engagement of quality resources for a longer time. Implementation of pre-validated software like LIMS, DMS, QMS, LMS are taking longer than 12 months and electronic batch manufacturing records (eBMR) are taking more than three years. Most implementations are going beyond the scheduled time due to rework and mid-way requirement changes.
The traditional V Model software implementation methodology follows a linear path from User Requirement Specification through Functional Requirement Specification, Design Specification, and then into IQ/OQ/PQ testing. While proven, this model has long cycle times and requirements may change midway — making modifications extremely expensive, especially when gaps are realized at the OQ stage.
The solution is to introduce a Configuration and Experimentation phase between the User Requirement Specification and Functional Requirement Specification stages. This allows business users to understand the pre-validated software and relate it to their problem statement before finalizing requirements. This approach helps realize requirements early, addresses regulatory audit observations related to revalidation and deviations, and can reduce implementation times by up to 70 percent.
This Configuration and Experimentation approach is best achieved through No Code/Low Code Development Platforms that support visual modeling — allowing users to see the application being built in real-time. When pre-validated GMP software like QMS, DMS, LMS, and eBMR are built on these platforms, addressing requirement gaps or changes becomes faster with minimal effort and fewer resources.
The way forward for pharma organizations is to select pre-validated software with visual modeling capabilities that deliver appealing digital experiences with human-readable application models while keeping costs constant. Software suppliers must focus on increasing speed with visual modeling instead of prolonged documentation cycles.
