The concept of Pharma 4.0 - leveraging advanced technology to make the drug development process faster, more efficient, and patient-centric - was introduced nearly 15 years ago, yet companies have been slow to adopt fully digital workstreams. Computer system validation (CSV) is a fitting example: today, most companies still rely on pen-and-paper – or a hybrid, “half-digital” approach – to manage system validation, even as an influx of new app releases drives up validation requirements dramatically.
Life sciences organizations executing computer system validation (CSV) are inundated with accelerating validation requirements, contributing to mounting validation debt. The integration of new SaaS systems has increased the number of releases and updates that must be validated per year; each system and app can require as many as 12 updates annually. This number is expected to grow as digitization expands to include nearly every aspect of the pharmaceutical technology chain, including manufacturing systems.
IT and Quality leaders need a way to rightsize their validation workflows. Companies can (and should) deploy a risk assessment strategy to ensure they are staying current with system releases as they adopt more technology. Strategic risk assessment involves more than staying current with system releases. It’s an approach to quality and compliance that prioritizes focusing on high versus low-risk tasks. This helps a company stay proactive and pay down its validation debt, lowering overall time and costs associated with validation while managing crucial risk factors.
But what is risk assurance management, exactly? Let’s explore how you can improve CSV quality and risk management practices to get ahead of potential compliance risks that life science companies often face. This comprehensive guide will help address regulatory compliance questions for risk strategies in the life sciences industry.
The key to rightsizing validation for your organization and enabling a proactive risk assurance management approach is building a policy based on systematic risk assessments (SRA). SRA involves the identification, analysis, and evaluation of potential risks that could affect an organization's objectives.
With SRA, compliance stewards set up a series of “gates” that add or remove a validation package’s risk score and business impact based on a set of pre-defined parameters, including standard operating procedures (SOPs) and best practices. Setting up manageable gates is crucial. Gating that is too complex can create workflow bottlenecks or recursive loops that keep assets to be validated stuck in limbo.
An effective SRA strategy also offers comprehensive technology risk assurance. Questions as simple as: “if I move this button, how will this affect my state of compliance?” are defined and ranked, allowing IT and Quality teams to understand and act on the action’s risk impact. Larger questions, such as “how do GxP practices impact this prospective change?” are also used for addressing risks.
Although the implementation of strategic risk assessment for computer validation systems is crucial, it is difficult to execute manually. Validation processes that rely on paper signatures, markup, scanning, or other physical tasks won’t be able to manage the risk that comes with validating tens, or eventually hundreds, of annual software releases and updates.
Digital workflows that automatically incorporate SRA allow IT & Quality professionals to deliver superior risk assurance through intelligent automation. Risk factors can be addressed for remediation before a human ever touches CSV documentation. This greatly reduces the time, effort, and cognitive fatigue associated with manual CSV, minimizing by orders of magnitude the number of packages that will eventually need to be validated. This also enables a shift from blanket testing towards more focused, risk-oriented testing; an imperative the FDA is also encouraging to streamline clinical development and approval.
Today, most companies rely on their cloud app vendors to provide CSV risk assessment and validation packages. But relying on external elements creates risk in and of itself; when respective companies’ timelines and priorities mismatch, additional time and labor are needed to reconcile perspectives and deliverables. Many life sciences organizations have experienced the difficulty of mitigating risks when there are multiple stakeholders involved in ensuring comprehensive coverage.
A better solution for risk assessment in computer system validation is to adopt an end-to-end paperless validation solution built on a modern, cloud-native architecture. An effective automated workflow engine allows companies to integrate automated risk assurance directly into their validation workflow, maintain change management and transparency at all points, and prepare audit-ready validation packages with minimal human effort. Seamless management of risk assurance in life sciences is all about resolving issues quickly, and that’s best done with a unified and fully integrated risk assessment validation solution that enables the implementation of effective risk management practices. This will remain especially important as regulatory changes are constantly evolving.
Life sciences companies that want to trade reactive for proactive CSV must make the leap away from paper-based systems to truly automated paperless solutions. Organizations that are slow to adapt add unnecessary time and costs, deepen their validation debt, and reduce risk assurance, exposing themselves to regulatory and financial consequences. Building SRA directly into the validation workflow is the most effective way to provide superior risk assurance in a heavily regulated, fast-moving environment. Manually reaching this state is extremely difficult, if not outright impossible.
Fortunately, the Res_Q Platform can help get you there. Res_Q is a modern, cloud-native paperless validation platform that automates, unifies, and accelerates validation in the life sciences. Res_Q’s workflow engine and intelligent risk assessment features build risk assurance directly into a company’s validation workflow, helping IT and Quality teams bolster their state of compliance in real time. Res_Q enables control over validation for over 30 industry-standard applications, such as Veeva Vault, DocuSign, and Box, from a single, app-based dashboard. With Res_Q, compliance stewards trade complexity for confidence, achieving peace of mind through the power of intelligent technology.
Learn more about the Res_Q Platform.