“Digital transformation” corresponds with the missions of medical technology companies, but the “when and where” of implementation depend heavily on the expected efficiency gains of available options. To compete with industry leaders, you must understand the relative values of your options and act on that knowledge. That’s why leading medtech companies have either committed to digitalizing validation or have already done it.
Digital validation is a no-brainer for medtech companies:
- Leadership sees heightened productivity across the product lifecycle and a streamlined path to market
- Employees spend less time on tedious, stressful, and repetitive daily tasks
- Patients benefit from next-generation technology even sooner
Paper-based validation slows product lifecycles. Re-creating protocols in Word, printing evidence, waiting for wet-ink signatures, managing Excel-based traceability matrices, storing in obtuse document management systems, and giving quality teams unstandardized outputs are archaic activities. If the products created by medtech companies are at the technological forefront of the life sciences, why do some continue using decades-old solutions? After all, digital validation can be leveraged across all aspects of GMP: CSV, facilities, equipment, and packaging.
Pharma 4.0 is underway. Soon, it will be impossible to compete without future-proof validation. The best strategy for those still using paper-based validation is to form an implementation plan now. The alternative is to be left behind.
Here’s a deeper dive into why medtech leaders are implementing dedicated digital validation tools.
You Won’t Be Successful in 5 Years Without a Digital Validation Strategy
Medtech devices rely heavily on validation; it is essential to satisfy regulatory bodies and ensure patient safety. This is not a compartmentalized need.
An increasing percentage of medical devices utilize custom software and IoT technologies that require validation. Meeting your development milestones is crucial, and the old-school model of paper-based validation poses a major competitive disadvantage.
It’s not enough to digitize with Excel, Word, and document management systems. They don’t enable modern opportunities for automation, workflow, distributed collaboration, electronic signatures, and reporting capability. They are non-transforming stopgaps, proxies for paper-based methodologies.
Modern solutions for digitizing validation are purpose-built. They expedite every phase of validation: authoring, execution, archiving, and everything in between. They enable a risk-based approach that applies critical thinking to avoid over-validation. When the correct technology enables the correct process, the process is what the team focuses on.
This is the technology and approach that’s necessary not just for rock-solid operations, but long-term agility.
Every Year of Waiting Costs Them Irretrievable Resources
Digitizing validation processes improves efficiency by 50%, freeing companies to expend efforts more productively. The human capacity for dealing with uncertainty is best suited for high-level problem-solving and innovation — defining characteristics of medtech leaders. Needless manual processes waste one of your most valuable resources: your subject matter experts’ brain power.
Digital validation also facilitates collaboration. This is critical if you want a high-performing organization. With instant, simultaneous remote access, working in a room together is unnecessary, as are search-and-retrieval efforts. This is significant, with workforces distributed across the globe.
Finally, younger talent will resist tools and technology that don’t harness modern capabilities. No one wants to print anything, ever. No one wants to train on a DMS that’s 20 years old. Modern technology makes you a far more attractive employer to next-generation workers.
CSA Is Part of Their Game Plan, and Digital Validation Makes It Easy
Risk-based critical thinking outweighs documentation in the new CSA methodology. Assessing risk at the beginning allows manufacturers to focus their efforts where they are truly needed.
Risk-assessment software tools like decision trees, templates, and real-time dynamic traceability matrices not only increase speed and efficiency, they help ensure ALCOA+ standards of data integrity, product quality, and patient safety. Automated enforcement of ISO 13485, ISO 14791, 21 CFR 820, and 21 CFR Part 11 through streamlined digital validation avoids potentially disastrous program delays.
An Audit Is Inevitable — Be Prepared
Before a device can be approved, it must be validated to ensure it meets end-user needs. In the FDA’s words, this means “confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” This includes packaging, instructions, and anything else that impacts usage, effectiveness, and safety.
In the event of an inspection or audit, purpose-built digital validation tools guarantee preparedness. A clear, instantly accessible audit trail cuts preparation time up to 90% while ensuring consistent documentation and compliance. Imagine: an inspection-ready report at the click of a button.
This posture of inspection-readiness has another benefit: data preparation during due diligence. In the event of an investment or acquisition opportunity, providing detailed, accurate, immutable reports on your validation history streamlines these critical transactions.
Summing It Up
Every advantage in speed to market is mission critical, and digital validation is a guaranteed method for streamlining that path. Pharma 4.0 is happening; there is no way around it. The decision that medtech companies must make is whether to reap its full benefits or delay and fall behind the competition.
