Skyline

Management and Analysis of Manufacturing Processes

Skyline is a unique software product that provides a complete and integrated solution for the special needs of Quality Control, Quality Assurance, Process Development and Manufacturing Processes in the pharmaceutical, medical device and biotechnology industries.

Skyline enables you to manage Manufacturing Monitoring and Analysis, Environmental Monitoring, Stability Studies, Sample Management and much more.

Skyline recognizes trends and deviations according to complex statistical rules, and in doing so, enables you to recognize abnormalities early on.

Skyline is a modular product, offering various functions:

Process Definition

Planning the processes that need to be analyzed by the system, including definition of manufacturing, environmental and stability processes, QC tests, control limits, sample points, sampling plans and sample tracking.

Data Entry Form

Data is retrieved by Skyline by interfacing with existing ERP or LIMS systems. For data that is not managed by these systems, Skyline has user friendly data entry screens.

Automatic Calculations

Sophisticated calculations can be introduced incorporating statistical, mathematical and logical formulas.

Data Analysis

Preconfigured charts and reports, together with user friendly query builders, display the data processed by the system including performance monitoring, trends, control limits and deviations. Data can be exported to Microsoft Excel for further analysis.

Trends and Deviations

Skyline can automatically calculate control limits for QC tests, identify statistical deviations, recognize trends, display graphs with the control limits, and generate deviation reports.

Sample Management

Defining sample points and creating a sampling plan for long processes. Printing sample bar-coded labels and tracking the location of the samples, missed samples and sample test results, eliminating the need for paper forms and logbooks.

Environmental Monitoring

Building of an environmental monitoring test plan, monitoring air, water, dressing and other environmental parameters. Identifying and reporting deviations. Generating summary reports according to batches, locations and dates.

Stability Studies

Creating stability test plans according to product and temperature. Entering and analyzing stability test data. Generating weekly and monthly test plans.

Certificate of Analysis (COA)

Definition of COA criteria for any item. Printout of COA per batch.