ABOUT SKYLAND ANALYTICS

Skyland Analytics streamlines drug product and process data management by offering cloud-based software solutions that ensure Part 11-compliance, data transparency and data integrity throughout the product lifecycle and supply chain. With deep expertise in manufacturing, IT systems, data analytics and product quality, we are uniquely positioned to provide life science organizations of all sizes producing clinical and commercial products innovative technology to enhance product quality and process analysis.

The first of its kind, Skyland PIMS® is the data hub where teams can rapidly create and manage process definitions, establish visibility into the status of all batches and manage specification and target control limits. PIMS transforms this data into shared, actionable insights by generating charts, reports and alerts that provide improved understanding and control of process and product performance. PIMS breaks down data silos and ensures data integrity among internal teams as well as external partners throughout the development and production supply chain.

Proven Use Cases

  • Transitioning off paper and spreadsheets into a FDA compliant environment
  • Creating efficiencies aggregating, analyzing and sharing process data across disparate systems and teams
  • Conducting scaleup and technology transfer activities
  • Improving data visibility among Sponsor-CMO networks
  • Preparing business and regulatory reporting, including Continued Process Verification (CPV) and APRs
  • Improving data integrity

Meting technical requirements

  • Cloud-Based
  • Controlled & Secure Data Sharing
  • 21 CFR Part 11 Compliant
  • Validatable
  • Persistent Knowledge Base
  • User Friendly
  • Easily Configurable
  • Minimal IT Involvement
  • Digital Data Source Connectivity
  • Rapid Deployment
  • Scalable to Fit All IT Landscapes
  • Low Total Cost of Ownership

VIDEOS & WEBINARS

Explore the advantages of cloud-based software in manufacturing data management and how to cost effectively scale your IT infrastructure to improve productivity, economic growth and sustainability.

In this webinar industry leaders identify novel ways to collaborate and improve adherence to cGMP requirements and ensure compliant quality production. Learn how you can establish reasonable expectations for data transparency and sharing in Sponsor/CMO relationships to ensure effective data management across the supply chain.

In this webinr a panel of experts  share their technology transfer, CPV, and validation experiences with and without the support of software. Discover how digital systems help overcome operational and regulatory hurdles through the sharing of accurate and timely product and process knowledge between development and manufacturing teams and across manufacturing sites.

In this webinar a panel of experts from discuss how now more than ever the bio/pharma industry needs to adopt strategies to improve the gathering, analysis, reporting and sharing of process data to establish indisputable integrity and improve decision making.

Already have existing systems? PIMS rapidly integrates with multiple commercial products and proprietary solutions to provide your organization with industry-leading data management and analytics that can be deployed in hours.

This joint webinar with Accenture explores the challenges within today’s increasingly decentralized and complex supply chain and how sponsors and CDMOs plan to address them.

Still relying on spreadsheets, paper records and disparate data systems? Enterprise systems too costly? Skyland PIMS® provides emerging and global drug sponsors and CMOs a collaborative, end-to-end workspace to seamlessly combine product, process and patient data management with analytics, charting and CPV reporting.

CONTACT INFORMATION

Skyland Analytics

7916 Niwot Road, Suite 200

Niwot, CO 80503

UNITED STATES

Phone: (720) 773-8800

Contact: Christina Wasik

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