ERP for biotech, pharma, and medical device organizations

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Improve your decision-making process with reliable, auditable accounting practices. Establish financial reporting standards for acquired entities or to prepare for acquisition. Ensure compliance with GAAP, IFRS, SOC1-3 Sarbanes-Oxley and the Sunshine Act.

Gain ability to effectively organize, plan, and execute projects while having visibility and complete control over product costing. Optimize your financial operations and maximize profitability by mitigating risks and managing your investments and projects.

Build effective and accurate supply chain projections taking into considerations procurement, quality, expiration, retest, manufacturing, forecasts, demand, sales, and more. Gain better visibility and predictability of your supply chain to ensure the resilience required to avoid risks and achieve operational responsiveness. More >

Proactively audit and qualify vendors with precision based on industry protocols. Digitally control, oversee, and enforce ordering from only qualified GMP suppliers to avoid production disruptions.

Manage materials with automated testing protocols, advanced expiration/shelf-life, re-test capabilities, automated label printing, and a streamlined overview of key inventory data. More >

Track and store inventory in multiple units of measure, and identify the amount of active ingredient each unit contains. Identify the location of every component wherever it is—in stock, in finished goods, or at a customer’s site—with serial and lot numbers.

Track the handling of raw materials throughout their preparation stage, capturing and storing information about the process and ensuring everything is auditable and done according to SOPs and specific batch requirements. More >

Leverage an extensible digital framework that simplifies your process of meeting GxP requirements, as well as ensures 21 CFR Part 820 and 21 CFR Part 11 compliance.

Manage various quality test points throughout the materials and production process. Track and manage all complaints, incidents, significant deviations, adverse events and material or process non-conformances, including alerts and notifications on stages. Prove a validated environment by establishing documented evidence of system and process consistency for intended use. More >

Electronically manage and document everything from materials evaluation and potency to equipment calibration and device/batch history records, across multiple modes of manufacturing. Track the handling of raw materials throughout their preparation stage, capturing information about the process digitally and ensuring everything is auditable and done according to SOPs and specific batch requirements. Streamline the collaboration with your partners (CMO, CDMO, CRO) and standardize the data flow of required manufacturing processes information (to ensure compliance). More >

Gain control of quality SOPs, validation documents, compliance documents, process specific instructions, analytic procedures, and more. All while amping up the secure, controlled collaboration your business requires.

Work securely with both internal teams and external partners following GxP guidelines and regulations, ISO standards, and maintaining 21 CFR Part 11 compliance. More >