We live in a paperless world. Yet many life sciences companies continue to perform validation activities manually, on paper, despite the high costs, errors, and inefficiencies that plague paper-based validation. Authoring, executing and approving validation documents manually wastes time and creates unnecessary audit pain and worker frustration. Moreover, antiquated manual validation processes result in higher operational costs and delays in releasing life-saving products to patients.
The benefits of moving from paper-based to digital validation extend far beyond eliminating paper. A true digital transformation process will help you enforce best practices, force standardization, and improve data integrity in your corporate validation process. This post will examine 10 of the most significant benefits of using the ValGenesis paperless validation lifecycle management system (VLMS).
Benefit #1: Reduce cycle time and inefficiencies by 50%
Fact: Paper-based validation processes are tedious and time-consuming.
Also fact: With features like digital workflows, electronic signatures and task notifications, the ValGenesis VLMS can yield serious efficiency gains. In a recent ROI study, ValGenesis customers reported a 50% overall efficiency gain on all validation processes and a 10% savings in project completion time, significantly reducing the time it takes to get products to market. A full breakdown of the survey parameters, results, and the formulas used to calculate the results are discussed in the 30-minute webinar, “How to (Really) Calculate the ROI of Digitized Validation.”
Benefit #2: Save money and time (lots of it)
Paper is expensive. It's not just the cost of purchasing paper but also the costs of printing and copying as well as secure shredding and disposal. And don't forget storage costs. If you're maintaining paper records onsite, be prepared to invest in lots of filing cabinets, which take up precious office space. Offsite document storage is even more costly with the added inconvenience and downtime of traveling to the storage facility to retrieve the file(s) and then traveling back to the office. Also, the inability to locate records quickly during a regulatory audit or inspection may result in costly compliance violations.
ValGenesis takes paper—and its associated costs and headaches—out of the validation process. No more printing, binding, shredding, storing or shipping. The solution is 100% paperless, 100% of the time. Critical validation information is securely archived in controlled digital repositories, so it’s easy to find if auditors come calling. When audits do occur, your data is already organized, stored and readily available for auditors with minimal prep work. In fact, ValGenesis helps you reduce audit prep time by 90%.
Benefit #3: Manage change faster with a proprietary process
Before a change can be implemented in a paper-based system, a change control request form must be physically printed, filled out, then submitted to a change control committee. That committee must set up a meeting to review/discuss the proposed change and decide whether to approve or reject the request. Only after committee approval can the change be implemented. It’s a lengthy, convoluted process—and completely unnecessary.
ValGenesis VLMS integrates and automates change management and validation, reducing change process effort and cycle time up to 80%. It offers a best practice change request form that incorporates priority levels and escalations. The system supports both requirement- and system-level changes and provides authorized users with the real-time status of all change control requests and associated tasks. With a “closed-loop” change management approach, you can instantly evaluate change impacts across the entire validation lifecycle. No other validation solution can assess change impact and visualize the impact automatically in a trace matrix between requirements and qualification protocols down to the step level. Learn more about trace matrices in benefit #5.
Benefit #4: Enforce consistency and compliance
One of the biggest challenges of working in a paper-based system is the lack of standardization. The secret to maintaining high-quality data is keeping it consistent across multiple sites and stakeholders. It’s virtually impossible to ensure your validation activities follow a consistent best-practice structure and are performed in compliance with required regulations when you’re relying solely on people, paper and manual processes. People make mistakes. Paper gets lost.
Human error can be minimized or even eliminated in a digital system. The ValGenesis VLMS empowers you to set business rules and automated workflows with pre-defined approval requirements to force standardization and good documentation practice (GDocP) compliance. Using decision-tree logic, users complete structured forms-based assessments that automatically generate protocols based on their input. These features enhance and enforce quality standards throughout your company. They also extend collaboration, communication, and approvals to include multiple sites and facilities, regardless of geographic location. With ValGenesis, you get the best of both worlds: global standard enforcement with site-specific autonomy.
Benefit #5: Dynamically create and update trace matrices
Identifying and fixing defects related to user requirements is a critical part of the validation process—and one of the most challenging. Whenever a change occurs, you must update the traceability data to reflect the change. In a paper-based system, this can be costly in terms of time and effort, particularly when changes are extensive.
ValGenesis’ trace matrix generation function enables you to quickly check requirements coverage, pinpoint defects, and then fix them to maintain project control. Traceability matrices can be automatically created and updated in real time to reflect changes made to specifications and test functions, then reviewed and approved through a controlled workflow. Many document types, such as user requirement specifications (URS), design specifications (DS) and functional requirement specifications (FRS), can be included in a single trace matrix, and ValGenesis supports forward, backward, and end-to-end traces.
Benefit #6: Improve collaboration and communication
In any lab, testing or manufacturing facility, teams must work collaboratively. Communication breakdown is highly likely in a paper-based system when document versions and revisions are constantly changing hands between team members. This rings doubly true when colleagues are dispersed geographically. Ineffective communication and collaboration lead to delays and poor results.
ValGenesis is web-based, so it can connect teams from virtually anywhere—whether colleagues are sitting next to one another or collaborating from different sites or home offices. Electronic tools expedite communication, and automating routing simplifies revisions and change tracking. And with information centralized and digitized, real-time collaboration—combined with real-time analysis of the process and automated trace matrix generation—ensures records are complete and compliant. What’s more, the ValGenesis VLMS integrates with other software applications commonly used in regulated environments, such as DMS and QMS, to connect different departments and operations company-wide.
Benefit #7: Get rid of data silos
Enterprise-wide data accessibility is critical to organizational success. This presents a challenge for organizations that compartmentalize data into disconnected silos, as is often the case with companies that haven't automated validation and other quality practices.
Good data is a valuable asset in today's digital age. Having access to accurate, real-time data that is standardized and easily referenceable helps you make better decisions and is the basis for organizational success. ValGenesis’ advanced analytics and reporting capabilities allow users to generate standard and customized reports to help increase management oversight. With ValGenesis, companies experience reduced user errors by capturing real-time evidence during the validation process.
Benefit #8: Experience less stressful inspections and audits
We already discussed how assembling and transporting paper-based records is a massive burden in benefit #2, but it bears repeating. Regulatory auditors are not interested in hearing about your document delivery problems. They don’t care how long it takes you to compile all relevant notes and track information regarding test results, revisions, changes, reviews, approvals and more. All they care about is the data.
One of the biggest advantages of a paperless solution is being audit ready, all the time. With ValGenesis, you are just mouse clicks away from a complete archive of digitized records with fully automated, system-generated audit trails. These tracked, tamper-proof audit trails empower you to maintain and fulfill the requirements of both EU and U.S. good manufacturing practices (GMP), including EU Annex 11 and FDA 21 CFR Part 11.
Benefit #9: Reduce, reuse, recycle
Ditching paper can certainly help you reduce your carbon footprint, but it can do so much more than that. In a paper-based system, the reusability of content is often restricted to templates and standard forms. Past documents, such as requirements and test cases, cannot be used to create new ones and must be rewritten from scratch each time.
ValGenesis’ paperless validation solution is a huge timesaver. In addition to templates and forms, the system empowers you to access, reuse/recycle and manipulate pre-existing documents to create new or edited content. You'll not only cut down on document authoring time but also enjoy greater levels of consistency and quality.
Benefit #10: Improve data integrity
Data integrity is a major concern in the life science industry. Manual entry of test results and parameters from instruments and equipment into validation documents and trending reports can cause major data integrity issues. Anytime manual entry is required, errors are inevitable. Raw data and files stored in different locations and formats further jeopardize data security governance. Automating this process increases the integrity of your data and allows you to focus on more productive, revenue-generating tasks.
ValGenesis VConnect captures data from instruments and equipment at the source, then plugs it directly into validation protocols, batch records and log forms—bypassing manual entry entirely. Raw data and files can be centrally archived securely, according to the corporate record retention policy. ValGenesis is the only paperless validation solution that is Internet of Things (IoT)-enabled and open platform communications (OPC)-supported.
Lisa Weeks, the marketing communications director at ValGenesis, writes extensively about technology, the life sciences and other regulated environments. Her work has appeared in many industry publications, including Life Science Leader, Quality Digest, Medical Product Manufacturing NEWS (MPMN), MedTech Pulse, Risk Insights, Medical Device and Diagnostic Industry (MD+DI), Medical Product Outsourcing (MPO), MedTech Intelligence, Pharmaceutical Processing, Pharma Manufacturing, Genetic Engineering & Biotechnology News (GEN) and Pharmaceutical Technology (PharmTech).