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
- Controlled & Secure Data Sharing
- 21 CFR Part 11 Compliant
- 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
Biotechnology Company Utilizes Process Data Management Software To Support Its Manufacturing Operations
Precision BioSciences (NASDAQ: DTIL) is a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies. Without automated data acquisition capabilities, batch data is manually recorded and transcribed into an Excel file, which is then e-mailed or shared on a network folder. Data is then verified and a PDF entered into the ELN for QA. All of this requires manual workflows. Learn how process data management software automated this workflow.
How Skyland PIMS Is Helping Novavax Accelerate Vaccine Production
Driven by its COVID-19 vaccine development and manufacturing data management complexities, this late-stage biotechnology company wanted to harden its data infrastructure, discontinue wide scale use of Excel for batch/process/product data management, and accelerate data sharing among a large external network. A data collaboration platform was their solution.
Cell And Gene Therapy Data Management
Industry experts address cell & gene therapy data challenges and what the product and process data-management ecosystem looks like for cell and gene therapy development and manufacturing.
Key Factors For Successful Technology Transfer
Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites.
Business And Legal Risks In Life Science Outsourcing
Significant business and legal risks threaten emerging and global life science enterprises. Among those are the industry's extensive reliance on external partners for product development and CDMOs.
Got Data? Using Informatics To Protect And Improve Your Business
Life science companies are realizing benefits from informatics in manufacturing. Are you ready to use data and analytics to improve decision making? There are things you can do now to get started.
Economic, Operational Advantages Of SaaS For Life Sciences Manufacturing
Over the past decade, Software-as-a-Service has reduced TCO by 77% compared to on-premise apps. SaaS providers now offer systems designed to meet the needs of FDA-regulated companies.
Using Software Systems To Drive A Successful CPV Program
This paper covers pharma manufacturing data management systems, with insights on how purpose-built systems incorporated into your CPV program meet FDA requirements and protect your business.
Selecting The Right Tool For Product-Process Data Management
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.
Leader In Restorative Cell Therapies Embeds Skyland PIMS® As Process Knowledge Base From Clinical To Commercial Manufacturing
A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. By implementing Skyland PIMS into their manufacturing plan, the drug developer is able to securely manage critical data in a collaborative, cloud-based, 21 CFR Part 11 compliant workspace.