Eliminate Paper. Eliminate Errors.

GxP Software to Digitize Paper Including Logbooks, Checklists, and Batch Records

GxP Software to Digitize Paper Records

Replace paper records, spreadsheets, and checklists with an electronic GxP software solution to support your digital transformation. Enable agile paperless manufacturing software by deploying electronic logbooks, forms, and batch records in rapid time.

Replace paper records, spreadsheets, and checklists with an electronic GxP software solution to support your digital transformation.

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Built for GxP compliance. Built for quality. Built for productivity.

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Combined Years of Experience

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Fortune 100 Customers

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Employees & Contractors

OpsTrakker Paperless Manufacturing Solutions

Providing cost-effective FDA compliant solutions in an agile manufacturing software.

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eLogBook - Electronic Equipment Logbooks
eForms - All GxP Paper (Forms & Checklists)
eBR Lite - Electronic Batch Records
eDatasheet - Manual Data Entry
Logo - eLogBook

eLogBook

Electronic Logbooks


GMP Software Solution

Logo - eLogbook

eLogBook

Life science software to deploy electronic logbooks for improved equipment management, tracking, and history.
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Logo - eForms

eForms

All GxP Paper Including Forms & Checklists


GMP Software Solution

Logo - eForms

eForms

Digitize GMP forms and checklists to enable FDA compliant electronic workflow executions. 
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Logo - eBR

eBR

Electronic Batch Records


GMP Software Solution

Logo - eBR

eBR

When traditional MES solutions do not fit, use OpsTrakker’s agile electronic batch record system.

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eWeigh

Electronic Weigh & Dispense Module


GMP Software Solution

eWeigh

Digitize slow, error-prone manual logs with our agile Weigh & Dispense solution.

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Logo - eDatasheet

eDatasheet

Manual Data Entry
Event Frame Manager

Software Solution

Logo - eDatasheet

eDatasheet

Prior to eDatasheet, limited electronic solutions were available to enable manual data entry into a PI System.

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A Few of the Companies Using OpsTrakker

JnJ Logo
Sanofi Logo
Novartis Logo
Pfizer Logo
Regeneron Logo
UT Logo

WHY OPSTRAKKER?

Replace Paper Records and Fill in the White Spaces of your Digital Transformation

Example Use Cases:

OpsTrakker Manufacturing Use Case

Manufacturing

  • Batch Manufacturing Records
  • Digital Work Instructions
  • Packaging Records
OpsTrakker Quality Use Case

Quality

  • LIMS Authorization
  • Quality Control Checklists
  • Execution Workflows
OpsTrakker Shipping Use Case

Shipping

  • Material Shipping
  • Labeling Forms
OpsTrakker Environmental Health Safety Use Case

EHS

  • Environmental Health
  • Periodic Assessments
OpsTrakker Security Use Case

Security

  • Access Request Forms
  • Access Removal
OpsTrakker Training Use Case

Training

  • On-The-Job Training
  • Training Requests
OpsTrakker Material Use Case

Material

  • Material Quarantine
  • Material Shipment
OpsTrakker Administration Use Case

Admin

  • Visitor Sign-In
  • Partner Notification Forms
OpsTrakker Use Cases - Filling In the White Space

Start Anywhere. Digitize Everything.

Learn more about these common areas to digitize GxP paper

Agile MES (aMES)

Agile Manufacturing Execution System (aMES)

Agile MES (aMES)

OpsTrakker’s Digital Enablement Platform provides No-Code MES functionality that changes the game by letting you digitize your production floor in small, manageable steps.

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Asset Tracking

Equipment Status and Location Tracking

Asset Tracking

Enable real-time asset management to track equipment status and location across your enterprise

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Logbook Management

Electronic Equipment Use-Logs

Logbook Management

Digitize your cleaning, maintenance, and use-logs with OpsTrakker to increase shopfloor visibility

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eSignage

e-Ink Labels and Displays

eSignage

Remove paper from your plant floor with real-time equipment and material labels

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Low Cost

Low Total Cost of Ownership

  • Rapid ROI Realization: Go Live Fast, See Results Faster
  • Pre-Validated: Validation Package Provided
  • Built-In Upgrade Path Included
  • Low Initial Investment AND Low Ongoing Cost
Pharma Ready

Life Science Ready

  • Built for Life Sciences: Created off Life Sciences Requirements
  • Unlock Data, Enable AI: Capture Data for Reports, Dashboards and AI
  • Meet regulatory agency requirements
  • 21 CFR Part 11 Compliant
  • ALCOA+ Principles Embedded
  • Deviation and CAPA workflow enabled
Easy to Author

Easy to Author

  • No Code / Low Code: Build workflows without writing a single line of code.
  • Quality Enabled: Built-in Exception Handling and Review-by-Exception
  • Intuitive Recipe Authoring Tools
  • Drag-And-Drop Workflow Builder
  • Configurable Without IT Support
  • Reusable Templates and Components
Deployed Rapidly

Deployed Rapidly

  • Quick Wins Early: Agile approach allows for deployments in weeks to months.
  • Robust Integration: Integrate with MES, ERP and other enterprise tools.
  • Phased rollout approach supported
  • Support from team of experienced consultants
  • Web based training available
  • Responsive help-desk to provide support
  • Minimal System Customization needed
Holistic Approach

Holistic Approach

  • Proven OCM Process: Proven Organizational Change Mgmt process ensures success
  • Customer Centric: Created from 30+ years of Life Sciences and MES experience
  • End-to-End Production Visibility
  • Warehouse and Inventory Integrated
  • Equipment and Material Tracking
Easy to Use

Easy to Use

  • User-Friendly Interface: Designed with the end-user in mind.
  • Mobile-First Approach: Your operations, in the palm of your hand.
  • Clean, intuitive user interface.
  • Mobile-Friendly Shop Floor Access
  • Barcode and Scanner Integrated
  • Real-Time Dashboards and Alerts
  • Paperless from Day One

Solution Features

Pharma 4.0 Ready

Enterprise ready, multi-tenant architecture

Real-time equipment and production dashboards

Designed for tablet: Nymi Band compatible

Digital equipment logbook software and work instructions

Streamlined authoring for paper-on-glass and complex use cases

Automatic labeling, hold times, and calculations

FDA compliant audit trail & history

21 CFR Part 11 (FDA compliant electronic signatures)

Connection with visualization tools

Integration with SAP, IIoT, and other backend systems

App for manufacturing company
About OpsTrakker

Ensure right-first-time manufacturing and compliance with OpsTrakker

From paper on glass checklists to complex records (e.g. eLogbook, eBR), OpsTrakker's Digital Enablement Platform provides high-quality and cost-effective digital solutions that replace paper-based records. Eliminate data input errors, reduce manufacturing review cycles and enhance your organization’s digitalization strategy with OpsTrakker.

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Business Benefits

Creating a seamless digital experience to meet your Pharma 4.0 needs

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Facilitate Compliance

 

  • Right First Time

  • GMP Software

  • FDA Compliant Signatures

  • 21 CFR part 11

Improve Manufacturing Operations

 

  • Review by Exception

  • Improved Operator Efficiency

  • Standardized Processes

  • Pharma 4.0 Ready

Unlock Manufacturing Data

 

  • Real-Time Plant Visibility

  • Production Dashboards

  • Enable Advanced Analytics

  • IoT Connectivity

Get In Touch

Contact us today for demonstrations, partnerships, press, and more

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EIS Locations - Global

Serving clients around the world, with offices in

The United States Canada Ireland Germany Turkey India Latin America

Contact us to advance your digitalization strategy!

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