Kneat

Digitize validation workflows end to end to support compliance, strengthen data integrity, and reduce validation effort and cycle times.

Helps organizations implement Kneat Gx, improve validation processes, and build lasting value from digital validation.

Build digital validation expertise, improve Kneat Gx adoption, and equip teams to use and scale the platform more effectively.

Gives medium-sized companies access to Kneat Gx capabilities through a software and services bundle tailored to their needs and budgets.

Kneat Gx

Kneat Gx is a configurable digital validation platform for life sciences and other regulated organizations. It supports validation processes from creation and test execution through review, approval, and reporting. Teams can configure document-centric or data-centric workflows without code and manage validation across disciplines in a paperless environment. The platform provides audit trails, role-based access controls, automated traceability, reporting, integrations, and tools for audit readiness. Kneat AI adds governed AI capabilities across the validation lifecycle, including content generation, review assistance, conversational guidance, and data analysis. AI-assisted actions are designed to remain governed, traceable, and inspection ready, with human review of AI-generated suggestions.

• Configure Workflows Without Code
  Adapt validation processes to organizational needs while managing them within one configurable platform.
• Protect And Trace Validation Data
  Maintain controlled, traceable validation records through audit trails, access and version controls, and governance for AI-assisted activities.
• Manage Validation End To End
  Coordinate validation activities across lifecycle stages in one platform, from creating protocols to executing tests, reviewing records, and reporting results.
• Prepare For Inspections
  Access traceable records and retrieve documents quickly to support preparedness for regulatory inspections and other audits.
• Generate Validation Content Faster
  Automated and AI-assisted generation helps teams prepare validation documents, reports, and tests more efficiently within compliant workflows.
• Focus Reviews On Critical Issues
  Surface potential issues in test execution documents so reviewers can focus on important decisions while retaining human oversight.
• Execute And Review Tests
  Manage test execution and review digitally, with traceable records that support validation documentation and oversight.
• Manage Diverse Validation Processes
  Use one platform for validation needs spanning equipment, systems, methods, processes, and other listed validation disciplines.
• Find Answers Through Conversation
  Ask questions and access validation information through conversational guidance and natural-language queries.
• Automate And Improve Validation Tasks
  AI assistance supports work across the validation lifecycle, while the Develop capability is intended to refine compliance models and identify potential risks over time.
• Record Compliant Approvals
  Document approvals electronically while maintaining audit trails for validation records and activities.
• Track Validation Activities
  Use reporting to gain visibility into validation activities and their status across processes and sites.
• Harmonize Global Processes
  Promote consistent validation practices across sites while accommodating local requirements and supporting organizational oversight.
• Reduce Validation Time And Costs
  Digital workflows can reduce validation cycle times and costs. Kneat reports cycle-time reductions of over 50% across multiple customer case studies and validation cost reductions of over 35% in a customer case study.
• Connect Platforms And Validation Data
  Use integrations and APIs to connect Kneat Gx with other platforms and make validation data available for AI initiatives and enterprise analytics.
• Support Faster Adoption
  Help teams learn and use the platform through an intuitive design intended to reduce training time and support collaboration.
• Collaborate In Real Time
  Allow team members to work together in documents during validation activities.

Kneat Consulting

Kneat Consulting provides expert-led services to help organizations deploy Kneat Gx, digitalize and optimize validation processes, and sustain long-term success. Customers can subscribe to a premium package or purchase essential services individually. Offerings include deployment, process digitalization and optimization, validation migration, tailored templates, work instructions and training, integration consulting, technical account management, and application training.

Category: Software Implementation Services

• Accelerate Kneat Gx Adoption
  Expert-guided deployment helps reduce implementation complexity and supports a faster path to using Kneat Gx.
• Transform Processes Into Digital Workflows
  Digital workflows help organizations modernize validation processes using Kneat's stated best practices.
• Align Validation With Operational Goals
  Tailored process improvements help align validation activities with industry standards and the organization's operational objectives.
• Preserve Data During Migration
  The service supports the transition of legacy validation documents into Kneat Gx while preserving historical data.
• Prepare Teams For Effective Adoption
  Teams receive instructions and training tailored to their processes to support effective Kneat Gx adoption and go-live requirements.
• Choose Services To Match Your Goals
  Premium and pay-as-you-go options let customers select a service model aligned with their validation goals and consulting needs.
• Extend Validation With Tailored Templates
  Customized templates help organizations accommodate additional processes, products, and documentation frameworks within their validation work.
• Connect Kneat Gx With Other Platforms
  API workshops, integration design consulting, and guided support help customers build connections between Kneat Gx and their platforms.
• Support Implementations And Upgrades
  A dedicated Kneat expert provides ongoing support for implementations and upgrades, helping maintain long-term platform stability.
• Build Kneat Gx Skills
  Expert-delivered training tailored to users' skill levels and organizational needs helps teams develop their proficiency with Kneat Gx.

Kneat Academy

Kneat Academy provides structured training to build digital validation skills and help users get more from Kneat Gx. Courses range from beginner to expert and include self-directed eLearning, instructor-led live training, and an online apprenticeship for Kneat partners. The curriculum covers role-specific platform tasks, including review and approval, administration, document development, equipment and deviation management, test execution, reporting, and entities. Training is offered to new customers, experienced professionals, consultants, students, and early-career learners, with certification available for advanced courses.

Category: Software Training Services

• Develop Advanced Kneat Gx Skills
  Customers can develop and certify advanced platform competencies through live, instructor-led training, including a Level 2 course that offers the highest level of customer certification on Kneat Gx.
• Build Skills For Specific Platform Roles
  Learners can focus on the platform tasks relevant to their responsibilities, from reviewing and approving documents to administration, execution, and reporting.
• Learn At Your Own Pace
  Learners can take self-directed online courses covering specific Kneat Gx roles and tasks, with course durations suited to the subject matter.
• Earn The Highest Kneat Gx Certification
  Kneat partners can pursue an expert-level apprenticeship and the highest certification available on Kneat Gx.
• Advance Skills At Every Experience Level
  Learners can choose training suited to their experience, whether they are new to Kneat Gx, advancing an existing digital validation program, consulting, or beginning a career.
• Accelerate Adoption And Scale More Efficiently
  Training helps organizations adopt Kneat Gx, get started faster, and build the skills to scale digital validation across their teams.
• Access Select Courses In Other Languages
  Select End User course versions are available in alternative languages, supporting learners who prefer to study in another language.

Kneat Go

Kneat Go is a software and services bundle that delivers the capabilities of Kneat Gx, tailored to the needs and budgets of medium-sized companies. It provides access to digital validation software and related services through Kneat Go resellers.

• Get Software And Services Together
  Access Kneat Gx capabilities and related services through one bundle designed around medium-sized companies’ needs and budgets.
• Access Digital Validation Capabilities
  Use a bundle that delivers the capabilities of Kneat Gx, Kneat’s digital validation platform.