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Electronic Batch Records Software

Improve efficiency and ensure regulatory compliance by automating your batch records processes.

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Ensure compliance with cGMP requirements

SimplerQMS electronic batch record (EBR) software system complies with cGMP requirements including compliance with 21 CFR Parts 210-211. This means that the system automatically stores a time-stamped audit trail of every document change.

Furthermore, our built-in 21 CFR Part 11 compliant electronic signatures and automatic workflows allow you to forget about the manual circulation of records and chasing wet signatures.

With SimplerQMS, you can configure your electronic batch records (EBR) system for different types of manufacturing processes.

Easily link electronic batch records to related documents, for example, device master records (DMR), audits, or inspection reports.

Ensure accuracy and avoid production delays

SimplerQMS enables you to store videos, pictures, and standard operating procedures (SOPs) for the operator’s instruction.

This allows operators to easily access any kind of equipment documentation.

Store data in one central location

Easily access the most recent batch record with complete data for a specific product.

In SimplerQMS, batch records are stored in the secured cloud-based storage and can easily be found in a single place. This means that anyone with permission can access the record at any time, from anywhere.

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Document Control

Keep your documents audit-ready while managing a high volume of data accurately.

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Training Management

Develop employee competence while maintaining compliance. Streamline the training process with learning rules and training groups, automate task assignments, reminders, and more.

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Change Management

Streamline change control processes from change request submission to final approval and successful implementation.

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Deviation Management

Enhance investigation, documentation, and resolution of deviations through a streamlined deviation management process.

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CAPA Management

Enhance your corrective and preventive actions to enforce continuous improvement and resolve issues as they arise.

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Complaint Management

Streamline your complaint management workflow and turn complaints into product improvement opportunities and increase customer satisfaction.

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Audit Management

Reduce the time and effort needed to pass audits successfully by streamlining audit-related activities.

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Risk Management

Consolidate and organize risk management documentation throughout all quality processes.

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Equipment Management

Simplify the equipment registration, calibration, and maintenance tasks with straightforward workflows.

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Supplier Management

Manage your supplier quality management processes across your supply chains, from initial qualification and selection through ongoing monitoring and performance measurement.

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What Our Customers Say

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Star review

“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”

Dorthe W.

QA/RA Manager, Cortex Technology

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Star review

“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”

Subba S.

Chief Technology Officer, CollaMedix

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Star review

“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”

Jean Claude M.

Head of Hardware and Software Development, hemotune

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

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