Change doesn’t come easily to pharma; it’s an industry that takes pride in the high degree of scientific rigor applied to both medical research and the practice of medicine. As a result, it may take some effort to convince key internal stakeholders to transition to digital validation workflows. The conversations outlined here will help you make a compelling case for a transition away from paper.
#1. How to Obtain a Commitment From Leadership
Getting executive buy-in is essential for any IT investment. Focusing on these three points will help you make the case that digital validation is worth allocating time and resources.
Better decision-making. Automating validation through digitization empowers business leaders to identify and remove bottlenecks in real time. Immediate access to data and insight enables more informed decision-making through the product development lifecycle.
Fast ROI. Companies can expect efficiency gains of 50% or more throughout the validation lifecycle. As validation makes up 20% of product development, digital validation cuts the timeline and cost of product development by 10%. The ROI will compound, project after project.
Support the move to Pharma 4.0. If pharma companies aim to transition to Pharma 4.0 – and gain a significant competitive advantage – they can’t do it with a paper-based validation process.
#2. How to Articulate Benefits to Business Lines
While executives want to know how digital validation affects the company as a whole, business unit leaders will benefit from knowing how their workflows will improve for the teams they manage. Use the following discussion points to lead conversations with department heads.
Validation teams gain access to a traceability matrix that’s generated and maintained in real time. This allows validation to happen in a much more agile manner throughout the product development lifecycle. It also enables teams to identify and mitigate issues before they pose a substantial risk to the product.
Quality assurance benefits from a standardized process. QA teams also can spend less time on the minutia and more time reviewing the technical controls that impact product quality and compliance.
Manufacturing and IT dramatically improve efficiency. Electronic workflows for creating and approving validation plans, generating traceability matrices, executing validation protocols, conducting risk assessments, maintaining revalidation schedules, and other tasks can lead to efficiency gains of 50% or more.
#3. How to Emphasize the Existing Precedent for Automation
One of the most common causes of pushback for digital validation is the notion that it represents a significant change. While this is true, it’s also true that many other business units within pharma companies have embraced automation. Highlight how these departments have benefited to show that the learning curve doesn’t need to be so steep.
DevOps leverages autonomous maintenance and monitoring to enable continuous delivery and incremental improvement of software products. Manual processes for maintenance and monitoring negatively impact productivity, making agile software development nearly impossible.
Security takes advantage of continuous threat monitoring and automated remediation to identify and respond to far more cybersecurity threats than individual security analysts could find using manual workflows.
Quality assurance automates the software testing process so it can be routinely done throughout the development lifecycle. This allows bugs and other flaws to be fixed before they impact additional features downstream.
#4. How to Demonstrate the Potential for Proactive Decision-making
One of the biggest benefits of digitization is that it enables validation to shift from a retrospective process to one that’s more proactive and prescriptive. Highlight:
Continuous validation. With traditional validation, much effort is spent on the initial project. Revalidation is resisted because the initial validation required too much time and effort. Automation allows validation to occur continuously throughout the development lifecycle – in minutes instead of months.
Up-to-date traceability. Likewise, automation lets companies build traceability matrices throughout software development and validation. Along with allowing companies to update matrices in real time, instead of creating them at the end of the manual validation workflow, automation helps companies ensure that matrices are readily available during an audit.
Issue resolution. Real-time validation identifies and prioritizes issues with a software product. One obvious benefit is fixing bugs as they arise. Another, more impactful, benefit is the ability to flag issues likely to cause trouble downstream. This lets engineers address these problems immediately, before they require significant and time-consuming rewrites to the application.
Process transformation. One of the biggest dangers of digitizing a manual process is bringing along the inefficiencies of working with paper, whether it’s data entry, version control, or communication with reviewers. Automating these aspects of validation transforms them into highly streamlined processes that occur in the background so reviewers can focus on tasks that require their full attention.
New standard operating procedures. Paper-based validation workflows have remained in place for so long because they’ve been the de facto standard operating procedure. The efficiencies and savings associated with digitized validation, from planning and tracking to execution and maintenance, allow pharma companies to rewrite the SOPs for validation once and for all.
Change is never easy. However, the sooner you start a conversation about the benefits of digitizing your validation process with a proven, purpose-built validation lifecycle management system (VLMS), the sooner your company will begin reaping the rewards. How have you communicated the benefits of digitizing to your stakeholders? Let us know in the comments.
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