Pharmaceuticals & biotechnology
Enhance safety and scalability with proactive quality and information management
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Unmatched expertise
Quality is our foundation. TrackWise Digital’s reputation for delivering quality management solutions and expertise to meet rigorous standards in the heavily regulated pharma and biotech industry is unparalleled.
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Industry leading QMS
TrackWise and TrackWise Digital set the standard for enterprise and digital quality management systems.
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Quality process accelerators
Leverage our Quality Process Accelerators (QPAs) for rapid value and process harmonization built on over 25 years of experience and best practice recommendations from our customer councils.
The digital quality edge
Change Control
Workflows saved more than 800 hours per year
63%
| 10x
|
Arbor has been able to improve both timeliness and efficiency with TrackWise Digital. The company has significantly reduced the length of time that change requests remain open with its CMOs.
“The availability of the system is fantastic,” says Emily King, All the change records are at our fingertips now. The search capability is our favorite feature; it’s much more robust than our old QMS. Plus, we can configure and customize TrackWise Digital workflows to meet our exact needs.”
Key QMS capabilities
Out of specification
Investigate OOS and document results and initiate actions with integrated workflows.
Deviations / CAPA
Handle deviations and CAPAs in a centralized location, along with associated investigations, approvals, and resulting records.
Complaint handling
Fully integrated CAPA system with automated routing, notification, delivery, escalation, and approval capabilities.
Audit management
An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval, and reporting.
Change control
Manage changes from requests, through pre-approvals, change execution, follow-up approvals, and implementation.
Risk management
Built-in templates comply with ICH Q9 for risk management throughout the entire product lifecycle.
TrackWise quality
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TrackWise Digital
Our TrackWise Digital® QMS solution is an industry-leading quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision-making.
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TrackWise QMS
TrackWise® is the world’s leading on-premise QMS software. TrackWise offers several industry best-practice workflows, bringing all your quality processes together in a single place.
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TrackWise AI
The world’s first AI-enabled capabilities specifically designed to improve quality and support Good Manufacturing Practices (GMP).
Discover TrackWise Digital solutions
Pharmaceuticals and biotechnology resources
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Blog
Accelerating time-to-market in Life Sciences manufacturing
Speed matters in life sciences manufacturing. Competitive pressure, complex product portfolios and evolving regulatory expectations all place increased emphasis on faster, more reliable delivery of new and existing therapies.
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Blog
From data to knowledge: Building workforce intelligence in pharma manufacturing
Pharmaceutical manufacturing generates vast amounts of data. Process values, batch execution details and event histories are captured every day. Yet data alone does not drive improvement.
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eBook
Optimizing pharma manufacturing: An executive guide to Overall Equipment Effectiveness (OEE)
Pharmaceutical manufacturing has never been more complex. The shift toward biologics, personalized therapies, and multi-product facilities demands precision, agility, and rigorous documentation. Yet, many manufacturing leaders still struggle to answer a basic question with confidence: How effectively are our assets actually performing?
