A long list of data integrity warnings received by pharma companies has made them 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 the digital transformation is going slower than expected, resulting in the engagement of quality resources for a longer time. Implementation of pre-validated software’s 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 updating with the latest changes. These complications should be addressed with smooth and flexible methods. In general, the OQ (operational qualification) duration is 60 percent of the total effort of a project. It is questionable whether such an effort is constructive for configurable software packages (GAMP category 4 & 5). Despite investing a significant amount of money and resources, they are unable to achieve the expected outcomes.
Key challenges
On the pharma industry front
- Business user requirements are not documented properly
- Unstable senior management.
- Lack of detailed functional requirements with traceability to user needs.
- High cost associated with change requests.
- Absence of a maintained or updated traceability matrix.
On the supplier front
V Model: Verification and Validation Model
Most software implementations in the pharma industry follow this model. The success of the V Model depends on having well-defined, unambiguous requirements and clearly defined acceptance criteria
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 modeling 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 with requirement documents, have to be updated. The cost of major change/gap requirements realized in the OQ stage might turn out to be very expensive and delay the validation process.
For the past 10 years, regulatory inspections have focused more on software and computer system validation. Deviations have been cited across all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting, and change control.
The traditional V Model: It must be revisited based on our real-time experiences
One important aspect is the Configuration and Experimentation phase. The introduction of this phase in between the User Requirement Specification and Functional Requirement Specification of the V model will help the business users understand the pre-validated software and relate the software with their problem statement.
This approach helps in realizing the requirements before the finalization of functional requirement specifications. The business user is clear on the software outcome.
Adding the Configuration and Experimentation phase in the implementation cycle will address regulatory audit observations related to revalidation, deviations and multiple release management.
The Configuration and Experimentation approach cannot be achieved through traditional configurable software. The configurable Software must have visual modeling capabilities which are commonly known as No code/Low Code Development Platforms. These platforms support Visual Modelling (The user can see the making of the application)
The organizations must ensure that the software service provider agrees to offer configuration and experimentation as part of the V Model. If the pre-validated software or configured software follows this model, implementation time can be reduced significantly.
This approach allows gaps to be easily identified during the Configuration and Experimentation phase. By reducing implementation time, it enables the completion of Operational Qualification (OQ) in a shorter duration, thus decreasing the overall project time.
No code/ Low code Platform
These platforms allow business and IT to collaborate in real-time, using visual models to capture business requirements as well as quickly iterate and scale apps while ensuring nothing gets lost in translation. The platform allows users to quickly turn their ideas into build-up applications and transform their manual processes into digital ones within days.
Low Code/No-code development platform provides drag-and-drop tools that allow business process engineering (BPE) teams to develop software quickly without coding. The platform provides drag-and-drop components to quickly assemble and design applications at reduced timelines and efforts. They also help increase business productivity and efficiency at the work level. Both developers and non-developers can use these tools to practice rapid application development with customized workflows and functionality.
Global enterprises are looking for No Code Platforms to build actionable digital strategies for every part of their business.
When pre-validated GMP software like QMS, DMS, LMS, eBMR, and Batch Issuance software are built using No Code/Low Code platforms, addressing requirement gaps or changes becomes faster and involves fewer people. Change management is simplified, allowing processes to be updated frequently. While traditional approaches may take months to implement even small changes, No Code platforms enable these changes to be made in a matter of days.
The platforms offer
The way forward for pharma organizations
Pharma organizations should now consider selecting pre-validated software with visual modeling capabilities (Low Code/No Code platforms). These platforms enable business users to create appealing digital experiences with human-readable application models while keeping costs consistent.
Way forward for IT organizations
Software suppliers should prioritize increasing development speed through visual modeling rather than focusing heavily on documentation during requirement finalization. Pharma IT departments and IT organizations should invest in No/Low Code development platforms to enhance productivity with fewer resources. Adopting these platforms empowers IT professionals to accelerate the delivery of architecturally complex applications.
