USE CASES

From R&D through early phase clinical, development and commercial manufacturing, Skyland PIMS® meets the requirements of life science organizations of all sizes managing product, process and patient data.

Transition Off Paper and Spreadsheets into an FDA Compliant Environment

Highly skilled resources are often called upon to gather product and process data from paper records and spreadsheets – an inefficient use of resources that can impair data integrity and cause delays in analysis and reporting. Skyland PIMS provides a single validatable “data library” to centralize, contextualize, analyze and share your product and process data. PIMS enables the coherence of digital (LIMS, MES, EBR, historians, etc.) queried and derived data as well as manually-entered data for high fidelity, rapid charting and data sharing.

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Accelerate Scale Up, Technology Transfer and Commercial Release

Skyland PIMS transforms data sharing by offering a centralized, dynamic, persistent and compliant process knowledge platform. PIMS Provides a common library of product and process data with a complete change history and audit trail of specifications and target control limits that capture authorship, timestamp and rationale. PIMS speeds scale-up and onboarding and provides seamless operational transparency thereby reducing costs and enabling compliance for the CDMO/CMO and sponsor.

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Achieve Data Visibility in Sponsor-CDMO/CMO Networks

PIMS bridges the information gap between internal and external teams and sites throughout all phases of development as it was designed for secure data sharing from a single source of data truth. User roles and permission settings align data entry, transfer, viewing and approvals with business needs, SOPs and FDA guidelines.

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Speed CPV, APR and CMC Preparation

As companies progress their drug candidates from development into commercial manufacturing there is a need to ensure access to accurate, reliable data for the preparation of regulatory submissions such as Continued Process Verification (CPV), Annual Product Reviews (APRs) and the Chemistry and Manufacturing Controls section of drug applications.  Skyland PIMS provides ready access to batch reports, CPPs and CQAs, raw material attributes, and historical limits and specifications data for segmented control charting and a variety of standard and advanced analytics.

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Realize Low Total Cost of Ownership

While it is possible to manage critical process data through manual efforts or use of Office applications, these approaches are error-prone and 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 efficiently addresses growth needs regardless of your stage of IT maturity– PIMS can be the enterprise’s first digital tool, or a complement to other systems whenever implemented. Cloud-based and intuitive, PIMS is deployed in 2 hours, easily configured by subject matter experts and requires no IT infrastructure, customization or coding. PIMS provides a full lifecycle TCO advantage while meeting the strict requirements of CFR Part 11 for life science manufacturing.

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