MANUFACTURING INFORMATICS

Effective use of manufacturing data is necessary to meet FDA guidelines for Continued Process Verification (CPV) and Quality Metrics. Data-driven decision-making also increases ROI on process improvements, cuts the time and cost of technology transfer, reduces cycle time and improves yield. We offer a range of consulting services that will improve the way you aggregate and analyze data to achieve your goals.

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Informatics Software Search & Selection

Our experts helped develop Discoverant,® the world’s most widely used informatics software for Life Science manufacturers. Leverage that expertise as you secure analytical tools for your production operations. We’ll assess your objectives, budget constraints and compliance obligations, then propose alternatives that deliver the most value to your business.

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Informatics Software Implementation & Training

Get configuration and training support from consultants who have deployed Discoverant globally.  Whether you’re acquiring a new system, expanding use of an existing one or training your staff to use more features and capabilities, our goal is making sure you get maximum value from your informatics investment.

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CPV Program Design & Implementation

While CPV is typically associated with FDA compliance, a strong program is the foundation for process improvement and operational excellence. Skyland experts have more than decade of experience creating effective CPV programs. We’ll work with you to identify relevant data, make it available to users for reporting and address critical cultural and organizational issues that often arise as CPV is deployed.

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Specialized Informatics Projects

If you’re experiencing process variability, product failures, technology transfer challenges or other manufacturing issues, get Skyland Analytics involved. Our experts will resolve your toughest challenges, applying knowledge, experience and best practices.

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Manufacturing IT Portfolio Management

Work with Skyland Analytics to maximize the value of your software portfolio. We’ll start by cataloguing existing tools and planned investments and mapping the functions of each. We’ll work with users to document how current solutions meet or fall short of their needs. Then we’ll recommend which software should be retained, reconfigured, updated, retired or replaced. The end result is a roadmap for a more efficient and effective IT portfolio.

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Manufacturing IT Architecture

Most manufacturers have several IT solutions that support production and testing processes—systems either bought or inherited through mergers and acquisitions. As you add capabilities for data capture, processing and reporting, you’ll benefit from a customized solution for IT requirements. Whether you’re a new company or an established one, let an independent expert create the optimum architecture for your data, regulatory, business analysis and reporting requirements.

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Manufacturing Master Data Management (MMDM)

MMDM is a comprehensive methodology that allows a company to define and link critical manufacturing data to “master data files” that provide a common point of reference. While many organizations have undertaken MDM at the corporate level, few use it in manufacturing because standard MDM approaches do not take into account the specific attributes of manufacturing data. We’ll work with you to create an effective MMDM program.

ACCOUNTANTS, ATTORNEYS, ADVISORS

Guide your clients to use data and analytics to attain higher levels of operational excellence.

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