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
Biosimilars Developer Automates Delivery Of External Manufacturing Partner Batch Data To Accelerate Workflows
A leading pharmaceutical company relies on CMOs to produce clinical and commercial biosimilars and other pharmaceuticals at scale. In support of its manufacturing operations, the company’s external partners collect large volumes of batch data that must be approved and reconciled; however, it had relied on manual processes, differently formatted spreadsheets and PowerPoints, email, and network file folders to manage batch records. The company needed a solution that could improve data visibility and sharing across their globally dispersed CMO network, automate process data analytics, and easily centralize and manage batch data, process specifications, and control limits.
Pioneer In CAR T Programming Technologies Centers Batch Data Management And Approvals Around Skyland PIMS®
A cell therapy developer has an extensive pipeline of CAR T treatments with its lead program recently entering pivotal trials. It wanted to move off of Excel-based batch data management to a centralized database to accelerate process verification with workflows and a single version of the truth. By implementing Skyland PIMS® allowed them to tightly control batch data review and build a clear audit trail.
The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.
Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).
How and why this late-stage biotech implemented a data collaboration platform, Driven by its COVID-19 vaccine development and manufacturing data management complexities.
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.
Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites.
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.
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.
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.
An area of life sciences that has recently received significant attention around data, its integrity, and its management processes, is manufacturing. This article covers bio/pharma manufacturing process information management systems, with insights on how purpose-built systems incorporated into your continued process verification (CPV) program helps meet FDA requirements and protect your business.
The use of spreadsheets in life sciences manufacturing carries high tangible costs that may not be so obvious: manual data entry, competing data sets entered by different users, version control, security, and delayed data migration to Part 11 compliant systems. Learn how to avoid the time, cost, and risks of spreadsheets with a process information management system to improve data integrity, remain compliant and make better, faster process decisions with confidence.
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.