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.
Save time with automated training activities, learning overview, reminders, and generation of training certificates.
Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.
Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.
Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.
Manage all the necessary processes related to product design and meet design control requirements with ease.
Automate and standardize your document control activities with ease.
Manage your equipment calibration schedule and automatically assigns tasks before due dates.
Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.
Plan and organize all your product management activities and integrate them with other processes.
Automate your audit-related activities and ensure better audit preparedness.
Consolidate risk and handle your risk management file in a well-organized and structured manner.
Simplify supplier-related activities and handle your supplier documentation following the standards.
Standardize your documentation processes and boost employee productivity with effective document forms.
Streamline the investigation, documentation, and resolution of all your deviations.
Simplify your issue management workflows by automating tedious tasks.
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.