For CDMOs, traditional challenges like capacity, margins, yield and capital requirements have been supplemented by new challenges. The growth in complex products such as biologics, cell and gene therapy and precision medicine has resulted in exponentially more complex processes – and more data. A survey performed by Accenture showed 67% of Sponsors say they have limited visibility and control over CMO product manufacturing and quality data. The need for more sophisticated process controls and data management tools, combined with ongoing regulatory demands such as CPV2, has put greater pressure on CDMOs to provide higher levels of data transparency while continuously demonstrating data integrity. Sponsors’ data expectations of CDMOs include:

  • access to more granular data, e.g. in-process parameters and CQAs;
  • access to data more frequently; and
  • generation of data in formats that allows easy reuse, analysis and reporting, while preserving confidentiality.

The ability to meet these new challenges is hampered by the near universal reliance on error-prone and time-intensive paper records and spreadsheets – or existing basic digital technology which may not enable secure and detailed data sharing. Adopting purpose-built software solutions allows CDMOs to address these challenges and secure continued product and process data visibility, compliance, timeliness and operational efficiency while creating a strategic differentiator to provide market leadership and improve their bottom line.

SKYLAND PIMS DATA COLLABORATION PLATFORM

Leveraging years of experience in manufacturing, IT systems, data analytics and product quality with fresh technology approaches, Skyland Analytics developed Skyland PIMS® as a validatable, collaborative workspace for management and analysis of product, process and patient data. As the Single Source of Data Truth, Skyland PIMS is a central knowledge base that reduces the time and effort spent sharing data manually

SKYLAND PIMS FEATURES AND BENEFITS

Single Source of Data Truth

  • Rapidly create and manage process definitions, establish transparency into status of all batches, manage specification and target control limits and generate charts and reports that provide improved visibility, understanding and control of process and product performance.

Faster Tech Transfer

  • Speed the development of process control strategies, process development, batch analysis and trending and achieve rapid onboarding and tech transfer with a full audit trail of authorship, change justification, rationale and time stamp with in-system document attachments, comments, URLs, and flowcharts.

Streamlined Workflow

  • 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).

Cloud-Based Platform

  • Realize cost-effective and timely access to data and documentation among internal teams across different geographic locations and throughout the sponsor network.

Secured Data Access

  • Set roles and permissions regarding data entry, transfer, viewing and approval that align with business needs and SOPs. Dedicated databases and software instances ensure data is shared discretely.

Scalable

  • Efficiently address growth needs regardless of existing landscape – the first digital tool, a complement to or springboard into other systems.

User-Friendly

  • Intuitive, user-centric interface is easily configured and requires no coding and minimal training. Authorized users can start creating process definitions, steps and parameters and/or transferring data within hours.

Validatable

  • 21 CFR Part 11 compliant and easily validatable – saving up to 80% time.

Seamless Analytics

  • Transform your data into shared, actionable insights. Batch data is automatically linked to specification and target control limits based on the manufacturing date and applicable sub-products or markets, to rapidly generate charts and reports including segmented process control charts (such as Individuals and Moving Range), Process Capability Analysis, Normality Testing and more.
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