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Batch Records


Intellect's Electronic Batch Records App Ensures Product Safety, Quality, and GMP Conformance 

What is a Batch Record?

A batch record documents the history of a manufactured product. It includes processing instructions to ensure its safety, quality, and conformance to GMPs. Batch records also contain specific information about product tests including analytical methods used and test results.

The FDA requires a different Master Production Records for each formulation and batch size, which can be complicated to manage. Using electronic batch records simplifies this process and reduces human error.

Batch Records screenshot

With Intellect's electronic batch records software, you can:

  • • Document Batch Production Processes with MPRs
  • • Show Compliance with Good Manufacturing Practices
  • • Create a Bill of Materials (BoM)
  • • Set Up In-Process Tests
  • • ID Batches and Batch Yields
  • • Create Batch Review Processes
  • • Complete Quality Control Checks and Signoffs
  • • Email Notifications for Task Assignment & Overdue Tasks
  • • Request Due Date Extensions
  • • Print Reports and Charts
  • • See Real-time Record Statuses

Need to Comply with FDA 21 CFR Part 11?

Intellect conforms to 21 CFR Part 11 and facilitates capturing, auditing, and validating electronic signatures & records.

Why Choose Intellect's Batch Records App?

  Extreme Configurability

Even though Intellect's Batch Record App comes loaded with workflows used by many industries, your business processes are unique.

Intellect's Batch Records workflows are 100% configurable. No coding required.

Electronic Batch Records on a Tablet