Electronic Batch Records
Kneat Gx efficiently manages all your validation data, including data points crucial to compliant electronic batch records. Combine batch records with your digital validation management for greater efficiency, enhanced risk mitigation, and more business value.
Why Use Electronic Batch Records
Electronic batch records are a helpful component of Good Manufacturing Practices that provide efficient, clear, and accessible information about the production of batches, typically in a pharmaceutical setting. These batch records are auditable and an important part of maintaining compliance in highly regulated industries.
Batch records typically contain information related to:
- The batch
- The process
- The materials or ingredients
- The equipment
- The process execution (e.g.: temperature ranges)
- The quality control testing
- Audit trails and approval signoffs
With so much information to be documented, and stringent Good Documentation Practices and data integrity requirements regulating the robustness of such documentation, it’s important to be able to quickly, confidently, and securely leverage electronic batch records.
Kneat Gx | Electronic Batch Records (EBR)
Unlike other solutions, Kneat’s electronic batch records feature is included in all Kneat Gx versions, with no additional software or hardware purchases, installation or qualification required. As Kneat uses dynamic data and entities, Kneat Gx can be configured to facilitate effective EBR management and prevent document errors that cause compliance issues.
Kneat Gx EBR Features
- Real-time equipment and qualification data can be added to batch records.
- Automatically update equipment tags/descriptions across the workspace with one change.
- Easily store critical information such as viable ranges, temperatures, processes, and more.
- Quickly duplicate steps for In Process Checks/Control Points when testing.
- Simultaneous execution and review for streamlined approval times and global remote functionality.
- Controls to limit human error (e.g., only manipulate executable fields).
- Enforced 21 CFR Part 11/Annex 11 compliance with ALCOA++ aligned processes.
- Template libraries to speed up creation and effectively manage batch records.
- Manage, draft, and approve deviations all inside Kneat Gx, access deviation data digitally 24/7.
- Uneditable audit trails for all actions taken within the system to fortify compliance.
- ‘Collections’ feature for improved audit readiness and reporting.
Client Story: A Risk-Focused Global Biotech
Transforming Traceability: From Prohibitive to Productive Risk Mitigation
Other Applications
Use Kneat to manage any validation, commissioning or qualification process.
- Audit Readiness
- Document Management
- Drawing Management
- Electronic Logbook Management
- Analytical Instrument Validation
- Utility and Facility Validation
- Process Validation
- Method Validation
- Equipment Validation
- Computer System Validation (CSV)
- Commissioning and Qualification
- Cold Chain Validation
- Cleaning Validation
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