If you’ve done your research, you know digital validation tools can improve efficiency for life sciences validation by up to 50%, trimming hours from your workflow and helping you get to market faster without compromising on quality or risking noncompliance. You’re convinced digitization is the right move for your validation processes – now it’s time to find the right software.
But identifying a smart, configurable software that reliably improves your validation activities and minimizes your compliance risks isn’t always straightforward – and making the wrong choice can jeopardize your budget and compliance standing. Before you buy, make sure the software you choose can deliver the features you need to make your purchase productive and profitable.
In this article, we’ll remind you how a quality digital validation system can benefit your business and highlight the key features you should look for in a digital validation platform before you commit.
Advantages of a software validation process
From staying compliant to keeping your competitive edge, there are many benefits a solid digital validation tool can bring to your operations. Here are a few to keep in mind:
Validate with confidence
Whether you’re testing drug interactions or bringing a medical device to market, confidence in your validation process is imperative. Digital validation gives you quality assurance, ensuring every validation stage has been passed and every standard met.
Streamline your workflows
Hit your workflow targets more smoothly. Work more productively and staff more efficiently. Validation software trims cycle times, protocol completion times, and process steps while maintaining your rigorous standards.
Stay competitive
Outdated validation practices threaten to leave your company behind. Paper-based, and even hybrid, processes slow your validation workflows drastically, making them noncompetitive – and potentially limiting your company value as a result.
Essential features in your digital validation platform
It’s tempting to choose a digital validation system based on reputation alone, but before you purchase, you need to know your software of choice offers the specific features you require. When you’re talking to software vendors and testing systems, be sure to push hard for details on precisely how they deliver the following:
Regulatory compliance
Validation compliance starts with meeting regulatory requirements for 21 CFR Part 11 and EU Annex 11, but it hardly ends there. Best practices from GAMP 5 to ALCOA++ scrutinize each of your validation activities, from how you handle electronic signatures to how you ensure data integrity.
The software you choose should allow you to meet regulatory requirements easily, plus provide ongoing risk assessments so you can spot potential compliance issues before they become a regulatory citation.
Look for configurable, automatic capabilities that enforce compliance while also allowing for your unique SOP-driven requirements..
Traceability matrices
A reliable risk-based approach should include traceability matrices, and your validation software should provide them. But to retain the streamlining advantages of a digital validation process, your traceability metrics need to be dynamic.
Insist on automated traceability features that link and track system inter-dependencies – without you having to define and monitor each one. Excellent validation software will remove the need for you to maintain your matrices by auto-linking between requirements and test scripts, generating maps of missing data, tracking changes, and providing risk level indicators beside validation items.
Audit readiness
When regulatory bodies want to take a look under the hood, your validation software should keep you ready with automatic audit trails and easy reporting. In the context of validation, audit readiness allows you to prove compliance within a few clicks with:
- Automated trails
- Instant document retrieval
- Real-time reporting and dashboards
- Change management and impact assessments
- Digital signatures and access logs
Good validation software removes the hassle (and worry) from compliance audits, essentially ensuring you’re always audit-ready.
Online testing
The beauty of a brilliant digital validation tool is that every part of the process is conducted within the system, including validation test cases such as IQ, OQ, PQ. From authoring to execution to approval, your validation activities are linked in real-time to your requirements, risks, and protocols.
Every step is live and digitally logged, and tests are executed within the software environment to maintain audit trails, timestamps, and user accountability more effectively than offline testing. It’s fast and efficient, and more reliable than the printing, scanning, and uploading required in yesteryear’s validation process.
How Kneat Gx checks every box for life sciences digital validation
It’s no surprise that top companies in the pharma, biotech, and medical device industries choose Kneat as their validation software vendor. Kneat offers every advantage of taking your validation activities online within an extremely user-friendly interface that reduces training time and optimizes your validation processes sooner.
Comprehensive validation
No matter what you’re validating, Kneat allows you to create and manage it in one, comprehensive platform. Relying on one platform for every validation need reduces procurement costs, speeds onboarding, improves integration and deployment, and allows you to scale faster, so your organization gets more value from the software.
Faster, reliable online testing
With Kneat, your validation testing has never been faster. You can perform validation tests on the facility floor and send for review and approval in real time. Wait time drops and your compliance is stronger than ever thanks to automatic timestamps and audit trails.
Smarter Requirements Traceability Matrix (RTM)
Our RTM automatically links every relationship between your documentation, testing, requirements, and their associated risks, so you can find high-risk dependencies at a glance and work to reduce risk with up-to-the-minute information.
Clear mapping, data and document accessibility, and demonstrable compliance – Kneat allows you to satisfy FDA inspectors and unlock business insights with one powerful software.
Data integrity that meets ALCOA++
ALCOA++ standards provide a common framework for data integrity, and if you don’t meet them, the FDA and EMA will find you non-compliant. Kneat helps you meet them easier by making sure your data complies with each ALCOA metric, plus the expanded attributes (++) of being complete, consistent, enduring, and available.
When it’s audit time, you can pull reports and documentation with confidence knowing your reports are configurable, accurate, and fully compliant.
Download the Kneat Gx overview for a full features list
Kneat Gx is established as pharma’s go-to validation solution, with 8 out of the industry’s top 10 companies choosing Kneat for validation. Read more about this fully-featured, pace-setting software and how it’s ideal for meeting the unique challenges of validation for life sciences companies.
