Life Science manufacturing data management has become increasingly difficult with advancements in complex biotech and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging those in other pharma operations, there’s a demand for accelerated tech transfer, FDA filings and commercialization. There are new business demands for information to be processed faster. Concurrently, regulatory scrutiny into data integrity is at an all-time high.
These challenges are compounded by the universal reliance on external partners for significant process development and manufacturing operations. According to a recent survey conducted by the Pharma & BioPharma Outsourcing Association, 50 percent of all drug products are developed or made by contract development and manufacturing partners (“CDMOs”). As the supply chain continues to expand in complexity, manufacturing data management is an area that demands new approaches/ innovation.
While it is possible to manage critical process data through manual efforts, or use of Office applications, these approaches are common sources of errors, can lead to long lead time, and are labor intensive. On the other end of the spectrum, traditional enterprise systems can be expensive, difficult and time-consuming to implement, cumbersome to use, and may lack the flexibility required for variable (shorter) production cycles.
Skyland PIMS data collaboration platform addresses the needs of all developers of therapeutic products and their CDMOs.
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. Skyland PIMS transforms this data into shared, actionable insights by generating charts and reports 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.
Enables secure and timely access to data and documentation across the external development and production supply chain to ensure data visibility and integrity and mitigate manufacturing risks that could impede FDA compliance.
Single Source of Truth
Establishes a persistent product and process data library throughout the product life cycle. Skyland PIMS retains a complete audit trail of all data entries (and process changes) with authorship, change justifications and time stamp. Attach or link to documents, comments, URLs, and flowcharts for additional context and accelerated report preparation.
Intuitive pre-configured workflows, electronic approvals (and rejections) and contextualization of key data such as Parameter Specification Limits, Target Control Limits and Batch data (metadata, discrete, continuous and replicate parameter data values).
Rapid Deployment / User-Friendly
Deployed in 3 hours, PIMS’ intuitive, user-centric interface is easily configured and requires no IT infrastructure, customization or coding. Authorized users can start creating process definitions, steps and parameters and/or transferring data within hours. Connectivity to digital data sources (e.g., LIMS, MES, historians) can be established if desired.
21 CFR Part 11 compliant and easily validatable.
Efficient Tech Transfer & Scaleup
Speed the development of process control strategies, process development, batch analysis and trending and achieve rapid onboarding and tech transfer with CDMOs and commercial release of product more quickly.
Secure Data Access
Set roles and permissions regarding data entry, transfer, viewing and approvals that align with business needs and SOPs. Dedicated databases and software instances ensure data is shared discretely.
Efficiently address growth needs regardless of existing landscape – the first digital tool, a complement to or springboard into other systems, Skyland PIMS is the data hub of your IT architecture.