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