Manne V Chowdhary, CEO & MD, AmpleLogic, elaborates on how to leverage digital technology to address regulatory challenges and to upgrade the verification and validation model in pharma companies
A long list of data integrity warnings received by pharma companies have made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitisation and building a data repository to make it easily available to analyse issues and predict challenges.
However, the current challenge is that the digital transformation is going slower than expected, resulting in engagement of quality resources for a longer time. Implementation of prevalidated softwares 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. This impacts all the documents and hence requires repeated updations with the latest changes. These complications should be addressed with smooth and flexible methods. In general, OQ duration is 60 per cent of the total effort of a project. It is questionable whether such an effort is constructive for configurable software packages (GAMP 5 category 4). Even after investing a good amount of money and resources, they are not able to realise the expected outcomes.
On the pharma industry front
- Business user requirements are not documented properly
- Unstable senior management.
- Functional requirements are not detailed enough and do not have traceability to user requirements
- Very expensive change request. (Cost of change)
- Inefficient cycle times
- Traceability matrix is not maintained or updated
On the supplier front
- Rigid systems (Need to write code for every major change)
- Lack of domain knowledge and unskilled programmers
- Traditional software implementation methodologies
V Model: Verification and Validation model
Most of the software implementations in the pharma industry will follow this model. The success of V Model is when requirements are well defined with no ambiguity and acceptance criteria well defined.
In the V Model there are long cycle times from user requirement specification to user acceptance test and requirements may change in the meantime. The modelling of user requirements without seeing a running piece of software is abstract and usually requirements for modification arise when the final user deals with the running software for the first time.
The traditional V model software implementation methodologies will not create an interest among the business teams as it takes longer to address a change. If any changes happen midway, then the test documents, along wit