Electronic Batch Records Software

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

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.

Configure your EBR system and link records to associated documents

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.

Looking for more modules?

Regardless of the stage of your Life Science organization, our integrated software modules cover all your needs.

Training Management Module Icon

Training Management

Save time with automated training activities, learning overview, reminders, and generation of training certificates.

CAPA Management Icon

CAPA Management

Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.

Complaint Management Module Icon

Complaint Management

Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

Design Control Module Module Icon

Design Control

Manage all the necessary processes related to product design and meet design control requirements with ease.

Document Management Module Icon

Document Control

Automate and standardize your document control activities with ease.

Equipment Calibration Icon

Equipment Calibration

Manage your equipment calibration schedule and automatically assigns tasks before due dates.

Electronic Signature Module Icon

Electronic Signatures

Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.

Product Lifecycle Management Icon

Product Lifecycle

Plan and organize all your product management activities and integrate them with other processes.

Audit Management Icon

Audit Management

Automate your audit-related activities and ensure better audit preparedness.

Risk Management Icon

Risk Management

Consolidate risk and handle your risk management file in a well-organized and structured manner.

Supplier Management Module Icon

Supplier Management

Simplify supplier-related activities and handle your supplier documentation following the standards.

Form Management Icon

Form Management

Standardize your documentation processes and boost employee productivity with effective document forms.

Deviation Management Icon

Deviation Management

Streamline the investigation, documentation, and resolution of all your deviations.

Deviation Management Icon

Issue Management

Simplify your issue management workflows by automating tedious tasks.

Nonconformance Management Icon

Nonconformance Management

Identify, evaluate, analyze and manage nonconformances more efficiently.

Trusted by companies around the world

Ready to learn more?

To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.

SimplerQMS Demo Interface