Validation 4.0: An industry transformation

The life sciences industry is on the precipice of a new frontier—a future that is digital-first and technology-led.

Bryan Ennis

October 19, 2022

3 Min Read
Validation 4.0: An industry transformation

The life sciences industry is on the precipice of a new frontier — a future that is digital-first and technology-led.

With the mass acceleration and adoption of software-as-a-service (SaaS) cloud systems—from discovery through to point of care—widespread digital transformation is a key business driver, saving companies critical time, resources, and spending. Despite this ongoing industry-wide shift, one business-critical aspect common to regulated companies lags: validation.

Historically, compliance has followed the industry practice of Computer System Validation (CSV), which is paper-driven, largely manual, and resource intensive. To advance the industry and deliver on the new and emerging technologies of Pharma 4.0™, the healthcare and life sciences industries must embrace validation automation – an automated, workflow-driven, data-centric solution. The industry must embrace Validation 4.0.


Moving beyond paper-based validation

Surprisingly, many life sciences companies are relying on paper-based validation – a painstaking and labor-intensive approach – despite innovative and emerging technologies. Even within the last year, the life sciences industry has been slow to adopt innovative digital solutions.

A recent report found that 62% of biopharma companies don’t use AI in day-to-day operations, and more than half (%) are not yet using the cloud.[1] Lagging outdated processes and legacy approaches causes a cascade of “tech debt” in regulated life sciences companies: Regulated companies often delay or avoid upgrading critical applications due to the time and effort required to validate new systems or test upgrades. The end result? Companies limp along on outdated or heavily patched systems.

The push to Industry 4.0 and Pharma 4.0™ compounds this problem as life sciences companies rush to keep pace with broader technology innovation trends. Trying to solve a technology problem with a paper system isn’t going to cut it. To resolve tech debt and speed up the availability of up-to-date systems which support the business, life sciences companies need to pivot from a reactive, paper process to a proactive, integrated process with technology at its core.

Validation 4.0 is a holistic and integrated approach to validation and the future of compliance across regulated industries – instilling trust and quality in the new technologies of Pharma 4.0™. Validation 4.0 prioritizes advanced technology and automation to ensure consistency in compliance and keep healthcare, life sciences, and SaMD companies in a state of inspection readiness.

Technology solutions to technology problems

Change across the life sciences industry, especially as it pertains to validation, is inevitable. As software development accelerates, teams, and systems need to keep pace. Organizations that can effectively move beyond paperless to data-centric methodologies and processes will have clear advantages.

Modernizing validation is an emerging quality imperative. With a changing work environment, technology is required to keep pace and remain compliant. Among new regulations, an increase in vendor releases, and the FDA resuming audits, it is more critical than ever to have the right partners, processes, and SOPs in place.

Organizations need a purpose-built validation system that can enable true process automation with built-in risk assessments. Fortunately, modern tools exist to ease the pain points and reduce delays. As investments in life sciences accelerate, organizations with digitized and automated processes possess distinct advantages.

Driving end-to-end validation across regulated industries, Sware enables painless adoption of emerging technologies for healthcare, life sciences, and SaMD companies – keeping companies in a state of inspection readiness. Learn more by visiting or requesting a demo of Res_Q™.

* Pharma 4.0 is a trademark and brand of International Society for Pharmaceutical Engineering, Inc. (ISPE)

[1] “Biopharma digital transformation: Gain an edge with leapfrog digital innovation” (Deloitte, 2021)

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