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Manufacturing

Manufacturing

Production Records

Master Production Record Software

Paper-based master batch production records are not efficient. They often have errors and illegible information. Master production record software resolves these problems.

Master production records are essentially written instructions for a specific manufacturing process, and the FDA requires a different master production record for each unique formulation and batch size. Master production software can help maintain master production records that meet FDA 21 CFR Part 211 requirements.

MasterControl Electronic Batch Records™ (EBR)
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Benefits of Master Production Record Software

01

Fewer Errors

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Mistakes are common with manual systems. Information can be written incorrectly or illegibly. Sometimes work is accidentally duplicated. An automated batch record system reduces the chances of errors being recorded on a batch record. With the ability to set data limits, incorrect entries are rejected.

02

Real-Time Visibility

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An electronic system can provide real-time visibility. This includes employee activities, training, quality events, and corrective actions. Capture, store and display all information in real-time. Have insight into operations as workers perform activities. Get a complete picture of operations.

03

Enforced Compliance

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Address common compliance pain points. Without paper, friction between manufacturing and quality teams disappears. An electronic system can automatically track and enforce training. It ensures operators follow procedures to meet regulatory requirements. Enforced compliance provides you with peace of mind.

04

Greater Efficiency

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An automated system can eliminate the problems of a manual system. It’s more efficient. Easily compile data from different departments and locations. Production records have fewer errors and reviews take less time. Operations are more efficient and time to market is reduced. 

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Batch Production Records

Batch production records are copies of the master production record. They are used to document information for each individual batch. According to the FDA, batch production records must be prepared for each batch of drug product.

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Production Record Review

Before a batch is released or distributed, all drug production and control records must be approved by quality control. This includes records for packaging, labeling and compliance. Unexplained discrepancies must be investigated.

Start managing people instead of paper.

Streamline processes by implementing electronic batch records.

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