Next-Generation Paperless Validation Services

Paperless validation utilizes electronic systems and tools to manage, document and streamline validation processes. This approach involves electronic documents, electronic signatures, digital records, and electronic workflows for validation activities. Performance Validation (PV) has partnered with ValGenesis to offer paperless validation services to pharmaceutical and medical device manufacturing companies looking to adopt a next-generation ValGenesis platform or paperless validation solution. Contact us today to begin your transition to a digital future.

Reduce Risk & Improve Compliance with a Digital Validation Solution

Forward-thinking pharmaceutical and medical device companies are switching to paperless validation to strengthen compliance and mitigate risks in their manufacturing processes. To support these needs, PV can implement and manage cutting-edge digital validation tools developed by ValGenesis and Kneat.

Seamlessly Implement Any Paperless Validation Platform

Count on PV to support you during the implementation and rollout of your new platform. We have experience implementing paperless validation platforms from various vendors, such as the ValGenesis VLMS platform and Kneat solution.

• ValGenesis software reseller
• Validation strategy and consulting
• CSV / CSA configuration alignment
• Implementation and post-implementation support
• Project management and execution
• Process Mapping Document (PMD) templates and document packs
• Training and production instance setup
• Pilot project, assessment, and consulting optimization
• Hypercare and administrative support
• Certified ValGenesis and Kneat Academy training

If you are a new client interested in adopting the ValGenesis VLMS platform, ask us about it when you contact us.

Proven Vendor Reliability & Support

It’s critical to select a vendor with a proven track record in the pharmaceutical or medical device industry, and who understands the unique challenges and validation requirements. The challenge lies in assessing vendor reliability, the quality of customer support, and the commitment to continuously support the solution in line with industry standards and technological advancements. Consider using ValGenesis and Kneat, two of the most reputable vendors in the industry. Rely on us to support your ValGenesis or Kneat platform throughout its entire lifecycle.

Overcome Integration Challenges

Integrating your new paperless validation solution with existing IT infrastructure and systems without disrupting current operations is a major concern. Feel confident knowing that PV has the expertise to provide a hassle-free integration that keeps your operations running smoothly.

Preserve Data Migration & Integrity

Partner with PV for a seamless and secure data migration process, transferring critical information from your current systems to the new solution with meticulous attention to preserving data integrity and accuracy. Our experienced team will ensure that your valuable data is smoothly transitioned, minimizing disruptions and maximizing the reliability of your new system.

Simplify User Adoption to Achieve Success

In pharmaceutical and medical device manufacturing, resistance to change is a common challenge that must be overcome to achieve success. Recognizing the significance of this hurdle, PV collaborates closely with all users to facilitate their training and ensure their comfort with the new paperless validation system. By prioritizing user support and engagement, PV aims to foster a smooth transition, enabling stakeholders to embrace the benefits of the updated system confidently.

Sustain Business Continuity with PV

Maintaining operational continuity during the transition phase requires careful planning, effective communication, and proactive risk management to minimize disruptions and ensure a successful implementation of the new paperless validation system. PV checks all these boxes with its comprehensive approach to business continuity. Count on our team to navigate the complexities of the transition seamlessly, providing expert guidance, robust support, and tailored solutions.

Streamline Paperless Validation with VLMS Express

If you are in a situation where you don’t have a direct account with ValGenesis or any other paperless validation solution but you still want a state-of-the-art paperless validation platform, PV has you covered. As a ValGenesis software reseller, we can set you up with a contract to use ValGenesis’s VLMS Express. This simplified cloud-based validation solution is perfect for organizations that need to start small, deploy quickly, and scale without issues. VLMS Express allows you to:

• Deploy quickly
• Implement with minimal effort
• Use an already validated platform
• Perform validation as a service
• Access a comprehensive documents library

 Enhanced Efficiency & Productivity

Paper-based validation processes are often time-consuming and labor-intensive, involving manual data entry, physical document management, and lengthy approval cycles. VLMS Express automates these processes, streamlining workflow, reducing manual errors, and significantly cutting down the time required for validation activities. This increase in efficiency can lead to faster project completion times and improved productivity.

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. VLMS Express, with features like electronic signatures, audit trails, and data encryption, enhances the security and integrity of validation data, ensuring that it remains accurate, complete, and fully traceable.

Superior Global Collaboration & Accessibility

VLMS Express facilitates better collaboration across different teams and locations. 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.

Unmatched Vendor Reliability & Support

Choosing a vendor with experience in pharmaceuticals or medical devices and who understands industry challenges and regulations is crucial. However, assessing their reliability, customer support, and commitment to innovation is challenging. PV makes it easy by only partnering with reputable vendors like ValGenesis to ensure optimal results.

Effective User Adoption & Training

The success of a paperless validation solution heavily depends on its adoption by the end users. Solutions that have a steep learning curve or 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 VLMS Express, a cloud-based digital validation solution for startups and midsized pharmaceutical and medical device companies. Our team knows all the ins-and-outs of VLMS Express, allowing us to properly train your team and provide ongoing support.

Increase ROI with Your ValGenesis Paperless Validation System

Justifying the investment in a paperless validation system requires a clear demonstration of its return on investment (ROI). This involves quantifying not only the direct cost savings but also the indirect benefits, such as increased efficiency, improved compliance, and reduced risk of non-compliance penalties. A recent study by ValGenesis found that its customers saw a 50% increase in overall efficiency by using its paperless validation solutions. 

Modernize Remote Interactive Evaluations

The U.S. Food and Drug Administration (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 paperless validation system like the VLMS Express to meet these requirements.

Experts in Kneat Solutions

Our team is undergoing comprehensive training to proficiently assist clients in leveraging Kneat solutions throughout the implementation and rollout process. We recognize the importance of providing robust support to Kneat clients at every stage of their journey, ensuring smooth and successful platform adoption. By investing in our team’s expertise, we aim to enhance the overall client experience and maximize the value derived from Kneat solutions.

Your Partner for Optimal Paperless Validation

At PV, CSV is at the core of our services, reflecting our deep commitment to ensuring compliance and reliability for FDA-regulated industries. With the evolution of CSV practices and industry standards, our team has remained at the forefront, equipped with extensive expertise to navigate the complexities of CSV.