Paper-based batch records are still widely used in cleanrooms. This often leads to errors and omissions in manual entries, compromising Data Integrity and requiring reviewers to carefully examine dozens (or even hundreds) of pages to identify issues, rather than focusing on actual non-compliances or deviations in production activities. As a result, batch record review becomes a tedious, repetitive, and time-consuming task that few want to perform, frequently causing delays in batch release due to the need to correct identified deficiencies.
Bluenext offers an Electronic Batch Record solution that helps progressively reduce paper usage and the associated errors and omissions while significantly improving efficiency.
With this solution, you can:
• Easily and progressively convert your paper batch records into digital format, starting from the original Word master file and preserving the familiar layout to ease adoption by operators.
• Enter data through any browser (tablet, laptop, or desktop PC).
• Automatically populate fields using barcodes, direct instrument integration, or embedded calculations, preventing errors and omissions.
• Simplify the review process through automatic generation of an Exception Report.
• Sign electronically.
• Enable simplified validation in accordance with GAMP 5.2, Configurable Software Category 4