How does MasterControl's EBR software ensure compliance with FDA and other regulatory requirements?

MasterControl is 21 CFR Part 11 compliant and offers tools to ensure software validation requirements are as fast as possible while being compliant. Our EBR can also connect to training documents, ensuring that only trained individuals complete the batch record.

Trusted By

Electronic Batch Records (EBR) FAQs

How do electronic batch records facilitate review by exception?

With paper batch records, review requires you to go through the record page by page. Review by exception is available in EBR systems and saves you time by immediately showing you areas that need your attention.

How can EBR systems facilitate compliance audits?

When you need to pull a batch record during a compliance audit, sifting through paper slows things down and sometimes you can’t find what you’re looking for. EBRs are easily searchable and let you quickly find what you need.

How is data integrity maintained throughout the life cycle of electronic batch records?

There are several components to data integrity. Legibility is automatically assured, every action is timestamped, electronic signatures make it easy to see who did what, and an EBR ensures users fill in information before proceeding to the next step.

How easily can EBR systems be customized to fit our specific manufacturing processes?

That depends on the system. Older legacy systems are much more rigid and may require you to change your processes to match the system. Newer systems can easily be configured yourself and changed whenever needed so your processes don’t have to change.

[ { "key": "fid#1", "value": ["Everything else"] } ]