Electronic Batch Record Software

Execute batches perfectly and accelerate release cycles

Replace paper batch records with guided digital workflows that capture data, enforce SOPs, and collect electronic signatures at the point of work. Build an immutable audit trail as the work happens so quality teams review exceptions, not paperwork.

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Pharmaceutical production environment
WHY ELECTRONIC BATCH RECORDS MATTER

Paper processes and rigid systems slow down commercialization

  • Paper batch records hide deviations and delay release

    Manual data entry and paper records turn batch release into a weeks-long reconstruction effort. When data is captured after the fact, deviations are found after the batch has moved, increasing the risk of costly rework and data integrity findings.

  • Validation overhead stalls continuous improvement

    Treating validation as a one-time event means every minor process update triggers a massive documentation cycle. When systems are too expensive to update, lean initiatives stall and frontline teams stop suggesting improvements.

  • Monolithic MES implementations take too long to deliver value

    Traditional manufacturing execution systems require heavy services to implement and force the operation to conform to the software. Lengthy deployments delay time to value and create rigid environments that struggle to adapt to new products or client requirements.

How Tulip automates batch records, enforces compliance, and accelerates release

Tulip’s composable electronic batch records deliver step-by-step guidance, automated data capture, and real-time alerts. They connect directly to the equipment, instruments, and enterprise systems you already use, creating a continuous audit trail that scales across global sites.

Right-First-Time Execution

Guide Operators and Prevent Errors in Real Time

Move beyond "paper-on-glass" PDFs to dynamic apps that actively prevent errors. Use in-process controls and conditional logic to guide execution, validate inputs instantly, and stop a process if an operator enters an out-of-range value.

Pharma work instructions for material dispense

Connect to Existing Systems

Connect Systems Without Custom Middleware

Maintain clear system-of-record boundaries by integrating your execution layer directly with your ERP, QMS, and LIMS. The platform pulls current work orders and recipes down to the floor and pushes completed batch data and lab results back to enterprise systems. Data flows securely across your architecture through standard protocols and open APIs.

Integrate with existing systems

End-to-End Traceability

The Audit Trail Builds Itself

Capture real-time genealogy data for every unit produced. The system links materials, equipment status, operator actions, and electronic signatures directly to the batch record. Complete and in-spec batches flag as ready automatically so quality teams focus strictly on deviations, cutting the time required to release a batch.

Barcode scanning for traceability

Risk-Based Validation

Iterate Safely Without Revalidating Everything

Tulip supports a Computer Software Assurance (CSA) approach that aligns with FDA guidance. Teams separate development, validation, and production environments to validate specific applications based on intended use and actual risk. Process engineers update manufacturing applications within established guardrails without triggering a massive documentation cycle for the entire platform.

App lifecycle validation

Governed Scale

Control Who Builds and What Deploys

Built-in governance controls your solution development lifecycle across multiple sites. Every application is version controlled and requires electronic sign-off from designated approvers before it reaches a production station. Role-based access and centralized workspaces ensure corporate quality standards apply globally while allowing sites the flexibility to adapt local parameters.

Governance and scale in Tulip

Customer stories

What leading pharma manufacturers have achieved with Tulip

See how life sciences manufacturers use Tulip to digitize batch records, reduce deviations, and scale across global sites.

Full paper-to-digital MES in 9 months

NextPharma transitioned from paper processes to a full digital MES across weigh and dispense, blending, and packaging in nine months. The shift reduced deviations and significantly accelerated batch release cycles.

"Tulip helped us in the beginning as we admitted missing capabilities between our central ERP system and the operators. So it really helped the operators to work on a daily basis and support how our products flow and, ultimately, the quality of the products we produced."

Joel FidalgoCIO, NextPharma
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Questions? We have answers!

An electronic batch record is a digital version of a master batch record used in pharmaceutical and life sciences manufacturing. Instead of relying on paper binders to track materials, operator actions, and quality checks, an eBR captures data in real time at the point of work. It records which operator performed a task, what equipment was used, and exact timestamps, building an immutable audit trail automatically.

Tulip connects to enterprise systems like SAP, Oracle, NetSuite, and LIMS through an open API and Connector Framework. It acts as the execution layer on the floor, pulling current work orders or recipes from your ERP and pushing completed batch data or lab results back to your LIMS. This architecture maintains clear system-of-record boundaries.

Tulip's platform aligns with FDA 21 CFR Part 11 and EudraLex Annex 11 requirements for electronic records and signatures. The system maintains an immutable audit trail, supports electronic signature controls, and manages access via SSO and role-based permissions. Every action taken by a human or an automated agent is logged with full attribution.

Tulip supports a risk-based, intended-use validation approach aligned with the FDA's CSA framework. The platform separates development, validation, and production environments, so teams can validate a specific workflow once and deploy it to multiple sites. This structure means process engineers can make minor, low-risk updates to apps without revalidating the entire underlying system.

Because Tulip uses a composable architecture rather than a rigid monolithic structure, initial use cases can go live in weeks. Manufacturers often start by digitizing a specific process, such as weigh and dispense or electronic logbooks, validate that specific application, and then expand to full electronic batch records.

Tulip governs change through centralized version control, workspaces, and approval workflows. A new version of an app requires sign-off from designated approvers before it can be published to a production station. Operations leaders can build an app once, validate it, and deploy it globally, maintaining central compliance while allowing local sites to adapt specific parameters if necessary.

Accelerate your batch release today

See how life sciences manufacturers automate data capture, eliminate paper records, and build continuous compliance at the point of work.

DisrFactory Illustration