Mx

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)
Download

Benefits of Master Production Record Software

01

Fewer Errors

02

Real-Time Visibility

03

Enforced Compliance

04

Greater Efficiency

Trusted By

batch-production-records-525x525

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.

production-record-review-525x525

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.

Get Your Free Data Sheet
[ { "key": "fid#1", "value": ["Product"] } ]
[ { "key": "fid#1", "value": ["Product"] } ]