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Forward-thinking pharmaceutical and medical device manufacturers are transitioning from paper-based validation to digital validation tools (DVTs), driven by FDA and industry guidance from ISPE. Performance Validation (PV) simplifies this transition with digital validation as a service (eVaaS). Simplify and accelerate your validation process by combining expert-led services with a cloud-based validation tool—no licenses, no subscriptions, just results.
Streamline CQV with Digital Validation as a Service
Our fully integrated eVaaS gives you access to a DVT as part of our Commissioning, Qualification and Validation (CQV) services. Unlike paperless validation solutions that only digitize documentation, eVaaS ensures an end-to-end digital validation process, covering:
- Critical utilities
- Building management systems
- Incoming raw materials
- API production
- Drug product production – fill-finish-inspect
- Packaging
- Warehousing
- Logistics
- Supply chain
By providing an all-encompassing digital framework, eVaaS eliminates inefficiencies associated with traditional validation methods and even first-generation paperless validation platforms. Implement a streamlined, cloud-based process that accelerates timelines, improves data integrity and reduces risk—without the burden of software ownership or complex implementation.
Paperless vs. Digital Validation: What’s the Difference?
Paperless validation utilizes electronic systems to manage documentation and workflows, reducing reliance on physical paperwork. Digital validation, on the other hand, takes validation to the next level by integrating cloud-based automation, real-time collaboration and intelligent data management into a single streamlined process.
Who Should Consider Digital Validation as a Service?
If your organization fits any of these descriptions, eVaaS is ideal for you:
- Companies new to cGxP or ready to commercialize.
- Organizations seeking a fully digital validation solution beyond basic paperless operations.
- Businesses without an existing validation system or using a minimal paper-based system.
- Established companies looking for a low-risk, scalable approach to digital validation.
Additionally, if your company is hesitant to transition fully, you can still leverage eVaaS as a stepping stone toward a digital future without the complexities of direct software management.
Why Choose PV’s Digital Validation as a Service?
Unlike standalone paperless validation solutions, our digital validation as a service removes technical and financial barriers by offering:
- No DVT subscriptions: Gain full access with no recurring software fees and unlimited reviewer, approver and retriever access.
- No access charges for active clients: Clients are not charged for DVT access while PV is an active service provider.
- Transparent service pricing: PV charges only for services delivered, including document transfer, document authoring, test execution, application administration, and cloning of PV’s content library.
- Cloud-hosted solution: The DVT is hosted in the cloud, eliminating client costs for hosting or data storage.
- Optional external authoring: Client staff and other vendors can author documents, subject to an access fee charged to the client.
- Exclusive system administration: PV is the sole application system administrator, ensuring seamless operation.
- Enterprise-grade validation without the burden: Clients gain full digital validation capability without licensing fees, subscriptions, validation or application expertise requirements.
- Flexible growth and exit options: Clients can transition to direct DVT ownership or maintain long-term access through PV.
PV’s Efficient & Compliant Implementation Process
Here is a step-by-step explanation of how the DVT implementation process works:
- Start with a preconfigured regulatory framework (GAMP 5), risk assessment criteria (FDA) and workflows.
- Tune to existing client operating practices as needed.
- PV points the DVT at appropriate data sources for initial document creation.
- PV may utilize existing proprietary content where applicable.
- PV and the client collaborate concurrently to finalize documents, which the client reviews and approves.
- PV executes test documents.
- Client reviews and approves test documents.
Improved Data Integrity & Security
Data integrity is paramount in the pharmaceutical and medical device industries, where regulatory compliance is non-negotiable. Paper documents are susceptible to damage, loss and unauthorized alterations. DVTs, with features like electronic signatures and audit trails, enhance the security and integrity of validation data, ensuring that it remains accurate, complete and fully traceable.
Superior Global Collaboration & Accessibility
eVaaS facilitates better collaboration across different teams and locations compared to traditional validation. Validation documents and data can be accessed, reviewed and approved remotely, enabling seamless collaboration even in geographically dispersed operations. This accessibility improves the agility of the validation process, which is particularly beneficial for global organizations.
Effective User Adoption & Training
The success of a digital validation solution heavily depends on its adoption by the end users. Solutions with a steep learning curve or that are not user-friendly can face resistance. Overcoming this challenge involves finding a solution that’s intuitive and easy to use, as well as providing comprehensive training and support to users. That’s why PV uses cloud-based digital validation solutions for startups and mid-sized pharmaceutical and medical device companies. Our team knows all the ins and outs, allowing us to properly train your team and provide ongoing support.
Modernize Remote Interactive Evaluations
The FDA may conduct a remote interactive evaluation to assess a pharmaceutical or medical device company’s compliance with regulations. This evaluation uses livestream technology and remote access to documents and information, allowing FDA inspectors to interact with facility personnel in real time without physically being on-site. When an FDA inspector asks to review documents, records and other information in your electronic systems, it’s essential to have a digital validation system to meet these requirements.
Your Partner for Digital Validation as a Service
With a proven track record of success, PV understands the unique challenges and regulatory requirements inherent in the pharmaceutical and medical device industries, providing tailored digital validation services to meet your specific needs. From validation strategy and consulting to implementation and post-implementation support, PV offers comprehensive services designed to streamline your validation processes and maximize efficiency. Contact us to discuss your needs and see how we can help.
Frequently Asked Questions
What is digital validation, and how does it differ from paperless validation?
Digital validation integrates cloud-based automation, real-time collaboration and intelligent data management. Meanwhile, paperless validation primarily digitizes documentation without automating processes.
What are the benefits of transitioning to digital validation?
Digital validation enhances efficiency, compliance, data integrity, collaboration and scalability while eliminating paper-based inefficiencies and human errors.
How does digital validation align with FDA and ISPE guidelines?
Digital validation follows industry best practices, including GAMP 5, FDA’s CSA guidance and ISPE’s recommendations for electronic validation systems.
How does PV’s digital validation as a service (eVaaS) work?
PV provides a fully integrated digital validation solution, including access to a validation tool, implementation support, training and ongoing administration.
What industries or companies benefit the most from eVaaS?
Pharmaceutical and medical device companies new to cGxP, expanding commercialization or seeking to replace outdated validation processes.
Does eVaaS require a long-term software license or subscription?
No, PV removes the burden of software licensing. Clients gain access to a digital validation tool without recurring software fees.
How does PV ensure data integrity and security during implementation?
PV follows strict data migration protocols, ensuring all validation data remains accurate, traceable and secure.
How do I decide if eVaaS is the right solution for my company?
Our team will work with you to assess your needs, current systems and goals to determine whether eVaaS aligns with your operational and compliance priorities.
Does PV support the implementation of my own DVT?
Yes. While our eVaaS model includes access to a digital validation tool, PV also supports clients who already have—or wish to implement—their own DVT.
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