Skyland PIMS

Accélérer le développement et la fabrication de produits biopharmaceutiques

Vous utilisez encore des feuilles de calcul, des documents papier et des systèmes de données disparates ? Les systèmes d'entreprise sont trop coûteux ?

 

Introducing Skyland PIMS®

 

PIMS™ provides clinical and commercial-stage bio/pharma developers and manufacturers a collaborative, end-to-end workspace to seamlessly combine product, process and patient data management with analytics, charting and continued process verification (CPV) reporting.

Cloud-Based | Deployed in Hours | Intuitive | No Training Needed | 21 CFR Part 11 Compliant

Why Skyland PIMS®?

  • Easily Manage Product, Process and Batch Data

    Manage product and process specifications and target control limits for in-process and final batch data

  • Accelerate Continued Process Verification and APR Planning and Reporting

    Maintains a complete change history for specs and limits with full audit trail, rationale and document attachments

  • Traditional ``Tech Transfer`` Disappears

    Speeds partner on-boarding and functions as the perpetual data library throughout the product lifecycle

  • Seamless Analytics

    Generates segmented control charts and process capability by linking batch data with associated specs and target control limit versions

  • Enhance Data Visibility

    Provides you and your manufacturing partners a secure, collaborative workspace with unlimited, role-based users

One collaborative workspace. Five integrated modules.

PIMS Lot

Manages batch data verification settings which can be pre-configured to flag out of range values. Provides approval workflows and dashboards to monitor data entry and batch release status.

PIMS Limites

Manages product and process specifications and target control limits. Provides an audit trail of changes, authors, approvers, date and rationale. Contextualizes data to feed analysis and reporting.

PIMS Analytique

Seamlessly integrates batch data with specification and target control limit versions to produce segmented control charts and process Capability to fulfill the FDA’s CPV reporting requirements.

PIMS Raw Materials

Quickly track, trace, and compare unlimited raw material quality and performance across vendors, lots, processes, and products. Provides genealogy tracking of material components in intermediaries and solutions through final product.

PIMS Stability

Centralize data from different steps in the développement de médicaments process and forecast product expiration dates and shelf life for the drug approval process. Substantially reduces time spent by critical staff in manufacturing, finance, capacity planning, and supply chain operations.

chercheur en biochimie travaillant avec un microscope

The transition from biopharmaceutical manufacturing development to full-scale manufacturing often represents a breakpoint in data management and its application. Skyland PIMS and Polar will enable IDBS to extend its BPLM coverage seamlessly from candidate identification through manufacturing in a highly regulated ecosytem.

industries des biens de consommation

L'association du IDBS Polar et du Skyland PIMS permettra de créer le premier système de gestion des données de bout en bout pour les produits biopharmaceutiques. Les données de développement et les données de fabrication peuvent coexister dans le même espace opérationnel et permettre une meilleure compréhension, une plus grande efficacité opérationnelle et l'accélération de la mise sur le marché de nouvelles thérapies.

Un seul système suffira-t-il à mon entreprise pharmaceutique ?

Pour la première fois, les données et les connaissances relatives aux processus peuvent être intégrées efficacement à tous les stades du cycle de vie, ce qui permet de naviguer dans les chaînes d'approvisionnement et les collaborations complexes nécessaires pour fournir aux patients des thérapies qui changent leur vie.

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