Skyline: Enterprise Scientific & Manufacturing Data Management
Combining ELN, LIMS, SDMS and BI features.

Developed by Comply, Skyline is a novel platform enabling organizations to manage and analyze Pharmaceutical, Chemical and Biotechnology process information and streamline Product Development processes from conception to clinical and manufacturing.

Key modules include:

  • Project, study and experiment management
  • Biotech processes from Downstream to upstream
  • In chemical R&D, information flows from synthesis
    to analytics to formulation and to Pilot production

  • Manufacturing monitoring & process improvement
  • Sample Management
  • Requests and workflows
  • Test Results
  • Stability studies
  • Environmental monitoring
  • Inventory management
  • Equipment and instruments
  • Statistical process control and Trends analysis
  • Advanced calculation engine
  • Electronic signatures
  • Automatic statistical process control (SPC) and Trends Analysis

Quickly define complex biotechnological or chemical synthesis processes and the operations and data that needs to be collected: analytical tests, chemical structures, measurements, process parameters, raw materials, consumables and equipment to be used; operations to perform and automatic calculations.

Skyline data layers

Create sampling plans, labels and sample tracking for analysis in the QC labs. Skyline detects deviations and automatically perform statistical process control (SPC) and Trends analysis.

Easily build stability and environmental monitoring plans. Skyline will print labels, barcodes and plan schedules. Notifications will be automatically issued.

Data captured into Skyline is automatically integrated with the process structure, resulting in a contextualized business view of the information which is key for analysis and reporting. Data acquisition is simple – enter data directly into Skyline, use bar-codes or connect to various instruments and control systems. Various screens are available for easy data entry.

A robust reporting and analysis module provides numerous tools for advanced analysis, investigations and reports.
Statistical Process Control (SPC) and Trends Analysis are done on data entry, scanning the data population to detect abnormalties.

Responsibility groups are used to create cross functional teams, securely working together on shared projects.
Skyline is 21 CFR Part 11 compliant and supports electronic signatures.

Skyline main screen

Skyline main screen

Skyline main screen

Skyline sample tracking

Skyline Trends chart

Skyline Conditional Formatting report

Knowledge Management and Quality by Design (QbD)

By integrating and contextualizing multilayered data, easily accessible with analysis and reports, Skyline provides a true knowledge management platform. The user friendly web interface makes information easily accessible to all users.

Industry guidelines such as Q10 and Q11 highlight the need for process understanding. This cannot be achieved without a flexible database that can accommodate and integrate the diverse information around the development and manufacturing of the product.

Step to achieve knowledge management

Operational Excellence – Using Skyline and Guide

Operational excellence is achieved through process performance improvements, monitoring and clear visibility of information. Mobideo Guide quickly converts manual procedures (such as SOP’s and work instructions) into managed electronic workflows. The integration of Skyline and Guide provide a robust, easy to use platform to capture data and integrate quality into the process. This considerably reduces risks of non-compliance, reduces data entry errors, approvals and release times.

Step to achieve knowledge management