Cutting-Edge Digital Validation Tools

Digital validation tools (DVTs) streamline the entire spectrum of Commissioning, Qualification, and Validation (CQV) in regulated environments, serving as intelligent platforms that maintain compliance while significantly reducing paperwork and minimizing the risk of human errors. At Performance Validation (PV), we provide digital validation tools to help life sciences companies modernize validation through industry-leading digital platforms like ValGenesis, Valkit and Kneat. Get in touch today to learn how we can help transform your validation processes.

Reduce Risk & Improve Compliance with a Digital Validation Solution

Innovative pharmaceutical and medical device companies are switching to digital validation tools 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, Valkit and Kneat. We provide expert implementation, training, content creation, and ongoing support to ensure faster validation, stronger compliance, and easier audits. Whether you’re starting your digital journey or optimizing an existing system, our solutions reduce risk and preserve data integrity, empowering you to focus on innovation while we manage the complexity of validation.

Seamlessly Implement Any Digital Validation Platform

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

Authorized Software Access & Certification

Gain access to leading validation software and rest assured knowing our team is fully certified in the platforms we support.

• ValGenesis software reseller: Access the industry-leading validation lifecycle management software through our authorized reseller partnership.
• Certified in ValGenesis and Kneat Academy training: We hold official certifications to ensure expert-level knowledge of these leading validation platforms.
• Multi-tenancy support for Valkit: Leveraging the platform’s multi-tenant architecture allows your organization to maximize efficiency through shared resources while maintaining essential data boundaries between departments or validation projects.
• Multilingual: Validation services in your preferred language for easier collaboration and better project efficiency.

Managed Services & Strategic Consulting

From fully managed validation operations to high-level strategy and assessments, we help you stay compliant while saving internal resources.

• Managed service provider for ValGenesis and Valkit: Comprehensive managed validation services for smaller companies utilizing ValGenesis and Valkit platforms, reducing your resource burden while ensuring compliance.
• Validation strategy and consulting: Strategic guidance for your validation approach, helping you develop a tailored roadmap that addresses your specific regulatory challenges.
• Pilot project, assessment, and consulting optimization: Targeted pilot implementations with comprehensive assessments to optimize your validation approach before full deployment.
• Digital transformation: Guiding your evolution from paper-based to digital validation systems while maintaining compliance integrity throughout the modernization process.

Implementation, Configuration & Support

We provide hands-on support from system setup to ongoing optimization, ensuring a smooth, compliant and efficient validation process.

• CSV / CSA configuration alignment: Expert configuration of computer system validation and computer software assurance processes to align with regulatory requirements and organizational needs.
• Implementation and post-implementation support: End-to-end support throughout your digital validation journey, from initial setup through ongoing maintenance and optimization.
• Hypercare and administrative support: Intensive post-implementation support and administrative assistance ensuring smooth operation during critical transition periods.
• Training and production instance setup: Tailored training programs and production environment configuration to ensure successful system adoption.

Operational Change & User Enablement

Successful validation goes beyond the technology. We help your people and processes adapt and thrive during transitions.

• Change management: Facilitating smooth transitions to new validation systems by addressing organizational impacts, user adoption and workflow adjustments.
• Process optimization and trainer: Analysis and refinement of validation workflows paired with comprehensive training to maximize efficiency and compliance.
• On-site service provider: Validation experts deployed directly to your location for hands-on implementation, training and support tailored to your environment.

Content & Documentation

Get the documentation you need—customized, compliant, and ready for inspection.

• Content creator: High-quality validation documentation, including protocols, SOPs and work instructions, tailored to your processes and regulatory requirements.
• Process Mapping Document (PMD) templates and document packs: Customizable mapping tools and documentation sets that streamline validation planning and execution.
• Program pack provider: Pre-configured validation templates and packages that accelerate implementation while adhering to industry best practices.

Execution & Oversight

Ensure every validation initiative stays on track with expert project management from start to finish.

• Project management and execution: Experienced coordination of all validation initiatives, ensuring on-time, on-budget delivery with minimal disruption.

If you are a new client interested in adopting a digital validation as a service (eVaaS) solution, contact us for more details.

Proven Vendor Reliability & Support

Selecting a vendor with a proven track record in the pharmaceutical or medical device industry and who understands the unique challenges and validation requirements is critical. The challenge lies in:

• Assessing vendor reliability
• The quality of customer support
• The commitment to continuously support the solution in line with industry standards and technological advancements

PV makes it easy by only partnering with reputable vendors to ensure optimal results: ValGenesis, Valkit and Kneat. Rely on us to support your digital validation tool throughout its entire lifecycle.

Overcome Integration Challenges

Integrating your digital validation tool with existing IT infrastructure and systems without disrupting current operations is essential. 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 digital validation tool. By prioritizing user support and engagement, PV aims to foster a smooth transition, enabling stakeholders to embrace the updated system’s benefits 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 digital 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.

Enhanced 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. With features like electronic signatures, audit trails, and data encryption, DVTs enhance the security and integrity of validation data, ensuring that it remains accurate, complete, and traceable.

Superior Global Collaboration & Accessibility

DVTs facilitate 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.

Bring Remote Interactive Evaluations Up to Speed

The FDA may use remote interactive evaluations to assess whether pharmaceutical or medical device companies meet regulatory requirements. These evaluations rely on livestream technology and remote access to documents, allowing FDA inspectors to communicate with facility staff and review records in real time, without setting foot on-site. When the FDA requests access to your electronic systems and documentation, having a DVT in place ensures a smooth and compliant review process.

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 digital 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.

Experts in Digital Validation Tools

Our team receives comprehensive training to proficiently assist you in leveraging a DVT throughout the implementation and rollout process. We recognize the importance of providing robust support at every stage of your journey, ensuring smooth and successful platform adoption. By investing in our team’s expertise, we aim to enhance your overall experience and maximize the value derived from DVT solutions, including:

• ValGenesis
• Valkit
• Kneat

In addition to implementation support, we offer digital validation as a service to ensure compliance while reducing your internal resource requirements.

Your Partner for Optimal Digital Validation

At PV, DVTs are a key part of how we help FDA-regulated companies stay compliant and efficient. As validation practices evolve, we stay ahead of the curve by bringing deep expertise and hands-on experience to support the successful implementation and adoption of digital validation platforms. Whether you’re implementing a new system or already have a DVT in place, our team is fully trained to deliver expert validation services within any platform environment as an on-site service provider. When you need expert digital validation, we are here to help.

Frequently Asked Questions