Enabling Data Visibility in Contract Manufacturing Networks
Skyland PIMS® – The life science industry standard for managing and sharing process and product data across your supply chain
Life Science manufacturing data management has become increasingly difficult with advancements in complex biopharma and “precision” cell and gene therapies. Meanwhile, with performance metrics in manufacturing lagging behind 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% 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 the use of Office applications, these approaches are common sources of errors, can lead to long lead time, and are labour-intensive. On the other end of the spectrum, traditional enterprise systems can be expensive, complex and time-consuming to implement, cumbersome, 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 improve 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.
Drug sponsor manufacturing (MFG) network
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 lifecycle. Skyland PIMS retains a complete audit trail of all data entries (and process changes) with authorship, change justifications and time stamps. 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 critical 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 two 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 & scale-up
Accelerate the transfer of historical and ongoing process and product knowledge, quickly advance process development and shorten the preparation time for CMC, CPV, APQRs and investigations.
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 discreetly.
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.
Drive a successful CPV program
The FDA mandates that manufacturers provide assurance that their manufacturing process will remain in control over time.
Skyland PIMS was purpose-built to support your CPV (Continual Process Verification) planning by enabling you to easily create segmented control charts, quality reports and other process analyses.
Find out more about smarter drug manufacturing process data management.
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