Paper-based validation is prone to human error. It stifles production efficiency, increases compliance risk, and hinders time to market, costing regulated companies tens of millions of dollars annually.
Companies that do not use paperless validation software face significant challenges: the high costs associated with inconsistent risk management, the downstream auditing of validation documents, and the time-consuming change management and continued qualification to maintain the validation status throughout the lifecycle of entities.In fact, traditional paper-based validation costs can represent almost one-third of the total resources required for an implementation.
Let’s take a deeper look at paperless validation and the current challenges of going paperless in the validation world.
What Is Paperless Validation All About?
Going paperless in validation is the modern twist of ensuring all the equipment, software, spreadsheets, utilities, cleaning, and processes in life sciences companies follow the rules set by the FDA, EMA, and WHO. It's a shift from the classic validation format that relies on reams of paper to record every step.
The beauty of paperless validation is that it brings a bunch of benefits to the table:
- Enhanced Compliance: Reduces regulatory risks for businesses and safeguards data integrity.
- Reduced Validation Costs: Speeds up processes, eliminating paperwork, saving on printers, freeing up physical storage space, and avoiding the need for document scanning.
- Streamlined Validation Status Maintenance: Reduces the time required to maintain validation status through regular updates and inspections.
- Simplified Audits: Provides instant access to data for smoother audit processes.
- Standardized Documentation: Adheres to sound documentation practices in line with GMP guidelines and frameworks like GAMP5®.
- Effortless Management: Enables real-time data accessibility for efficient online management.
- Environmentally Responsible: Minimizes paper use, eliminating the need for printing, storage, and physical document management.
In short, paperless validation leverages purpose-built digital technologies to streamline and optimize validation processes while reducing the reliance on physical paperwork. This approach offers numerous benefits, including cost savings, efficiency gains, improved data accuracy, and a reduced environmental footprint.
Which Systems Enable Going Paperless with Validation?
ISPE says a "paperless validation system" is supposed to let you create, approve, and run tests without having to print a single sheet of paper. This "paperless validation" term has been buzzing around for about 20 years now, but are we really there?
Several tools in the market claim to take validation processes paperless. The market leader is the ValGenesis Validation Lifecycle Management System (VLMS).
The VLMS is designed to manage the entire validation lifecycle electronically and remove the inefficiencies that plague paper-based processes. This 100% paperless validation solution reduces the cost of validation by optimizing and stabilizing existing processes and procedures. Customers say their validation lifecycle processes have improved by 50% or more simply from implementing and harnessing the power of the ValGenesis VLMS.
Why Isn't Paper Completely Gone Yet?
The life sciences industry continues to accumulate stacks of paper for various reasons.
In 1997, the FDA introduced 21 CFR Part 11 for Electronic Records and Electronic Signatures because the concept of electronic data was on the rise. Most crucially, the regulation ensures that data is correct and has the necessary checks and balances.
Nowadays, we're drowning in electronic data. But here's the kicker: many organizations still print out loads of data (even more than they need!), stamp it, and file it away. They do this despite having a 'paperless' system that's 21 CFR Part 11 compliant in the first place.
Why? Well, because the natural conservative nature of teams leaves too many "what ifs" unanswered.
- "What if the system crashes?"
- What if the inspector wants paper copies?
- What if we can't find the information in time?
- What system is the real data in, and is it the official one?
It's good to have answers for these "what ifs," but their importance is relative to their risk profile, and a proper risk assessment wouldn’t necessarily consider all the “what ifs” as high risks. And they wouldn’t require a complete set of mitigation measures such as paper printing.
However, more often than not, the conservative voices win. The risk is considered high, and the solution is often, "Let's print to PDF, store it in another 'electronic' document management system, or pop it into a folder."
Of course, we need backup and disaster recovery plans to keep our data safe, especially product-related information. But transferring all that data from one system to another just adds more tech debt and data bloat, making the problem of data explosion worse than ever and feeding the growing risk of data integrity vulnerabilities.
The Cost of Storing Data
Regulations like 21 CFR Part 314.420 and 21 CFR Part 814.46 recommend keeping data for at least two years after approval or after you stop selling a product. However, many organizations hang on to data for 15 years or more.
The problem is that these archival policies are often unreliable, and it's hard for companies to figure out when to ditch their data. So, they end up keeping old systems long past their expiry date along with all of the other data they've collected over the years. And all this is done on the slim chance that an auditor might want some ancient data that's a pain to dig up.
If we're afraid of that, we need to get to the root of the issue and figure out how to ease those fears.
A Matter of Trust
In the world of life sciences, trust is a big deal.
Peer reviews are great and should always be part of the process, but sometimes the industry goes overboard. Instead of trusting the system, companies set up manual processes that ignore the tech's capabilities and the capabilities of the people using it.
Paperless validation systems are designed to automate business workflows and ensure things get checked within the system itself. But, due to the lack of trust, we end up with too many reviews and approvals, often at points where one party might not know much about the data.
We don't trust that the data being put into the system is correct, so we want the system to do all the checking. We pile on extra checks and even print data reports for people to review and approve.
Many companies and quality teams prefer to hand over flat file documents for auditors to check. They don't consider letting the auditor peek inside the system or talk to the team that runs it. This ends up making life hard for the tools and processes.
A Paperless Future
From what we’ve discussed so far, it’s clear that the path toward a paperless validation future depends on three points:
- Obtain the right technology.
- Adjust internal processes to take advantage of that technology.
- Trust that new process.
By taking these three steps, paperless validation systems can actually lead to truly paperless validation environments.
Is Current Technology Capable of Making Validation Truly Paperless?
For instance, when using the ValGenesis VLMS, you gain access to a comprehensive approach to validation that is built on risk-based principles. VLMS empowers users to conduct assessments at various levels, including requirement, functional, or system assessments, allowing for the determination of the most appropriate level of validation required.
Automation is also a feature, offering the advantage of authoring through decision tree assessments, thereby eliminating any guesswork in the validation process.
Another feature is its ability to seamlessly support different change control process workflows, categorized by change type, using easily navigable process maps. This functionality simplifies and streamlines operations while ensuring the accuracy and efficiency of the validation process.
The VLMS also promotes effective collaboration, accommodating validation methods such as agile, waterfall, linear, or any other method that aligns with the specific requirements of your business. Furthermore, the system integrates seamlessly with third-party applications, allowing for the smooth synchronization of development, testing, and overall business operations.
Thus, adopting VLMS can significantly enhance regulatory compliance by executing quality processes, thereby ensuring that all quality processes align with regulations and standards. The system facilitates quality by review through standardization, preapproved workflows, and readily accessible audit trail metadata.
What is the Real Return on Investment?
We can only speak for VLMS, but we do have a few numbers:
|AREA WITHIN THE VALIDATION LIFECYCLE||VLMS TYPICAL IMPACT|
|Creating, reviewing, and approving validation plans and projects||20-30% more efficient|
|Authoring, reviewing, and approving validation protocols||20-30% more efficient|
|Creating and maintaining traceability matrices and requirements||40-50% more efficient|
|Executing, reviewing, and approving validation protocols||40-50% more efficient|
|Performing, reviewing, and approving risk assessments and maintaining the validation status||40-50% more efficient|
|Creating and maintaining periodic reviews (including risk management) and revalidation schedules||40-50% more efficient|
|Tracking the validation status||70-80% more efficient|
|Audit preparation for internal and external audits||80-90% more efficient|
|Document retrieval||70-80% more efficient|
|Validation metrics for resource and budget planning||50-60% more efficient|
Are There Some Features Missing from the Technology?
That depends on the software. Most solutions do an acceptable job of digitizing the validation process —that is, moving the process from paper to glass. And they all imply and allow for a redesign of the processes that boost organizational efficiency and effectiveness.
When we talk about digitalization, we're talking about:
- Requirements management and tracing to test cases and design specifications
- Role-based security and workflow management
- Electronic document validation deliverables
- Links with automated testing software and requirements lifecycle management
- Traceability and risk assessment or risk profile management
- Scrum and agile approaches to development, testing, and release management
For that, we can only recommend the ValGenesis Validation Lifecycle Management System (VLMS).
ValGenesis is Ready to Help You Go Fully Paperless with Validation
ValGenesis is ready to help you transform your validation processes into a fully paperless validation system. The ValGenesis VLMS is the industry standard digital validation platform for life sciences worldwide. Peerless in capability, it empowers you to enforce standardization, ensure data integrity, reduce risk, lower the cost of quality, and strengthen your compliance posture.