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Electronic Batch Records Software

Digitally manage batch record documentation to improve traceability and support GMP compliance.

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Join Over 5,000+ Quality Professionals Who Trust SimplerQMS

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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

Centralize and control documents and records with version control, e-signatures, and audit trails.

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Training Management

Automate and manage training activities to support staff competence and maintain controlled training records.

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Change Management

Streamline change control processes from request submission through review, approval, and implementation.

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Deviation Management

Record, investigate, and document deviations to support timely resolution and compliance.

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CAPA Management

Identify and address quality issues, implement corrective and preventive actions, and reduce recurrence risk.

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Complaint Management

Log and manage customer complaints to support investigation, traceability, and reporting requirements.

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Audit Management

Plan, conduct, and document audits to support inspection readiness and timely follow-up.

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Risk Management

Identify, assess, and document risks to support mitigation and protect quality and compliance.

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Equipment Management

Track and maintain equipment to support accuracy, availability, and compliance.

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Supplier Management

Qualify and monitor suppliers to maintain oversight, traceability, and regulatory compliance.

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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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