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Batch Records Management

Quality Events

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Manage the correct documentation and batch record management process demonstrating that each product is manufactured according to industry standards and Good Manufacturing Practices (GMP).

Empower easy communication with internal and external stakeholders including regulatory agencies. Gain oversight and keep track of the equipment, materials, staff, data, labels, events, supplies, laboratory information management systems, process control systems, and enterprise resource planning

Benefits

Compliance

The CARA Life Sciences platform is 21 CFR Parts 210-211 certified and ensures you adhere to the FDA’s CGMPs, allowing you to document the production, packaging and holding of each batch of a drug product.

Traceability

Track and manage the production documents related to a Batch, oversee when they were printed, by whom and why, and get reprints in an audited manner - and/or go electronic for this process. 

Better Quality

Avoid data duplication and human error with standardised processes to avoid production delays and decrease time to market.

Single Platform

Be certain that you are accessing the latest version of a document and use our information lake to compile and centralise data and content. Enter once and reuse information, with traceability and access to enterprise-wide information, all one click away.

Granular

The information is stored in a granular manner: easily find and print a single page rather than all documentation for the whole batch.