MANUFACTURING IT DATA SYSTEM CONNECTIVITY

Our technical team has 100 years combined experience deploying drug manufacturing data systems. Skyland PIMS can be deploy in a few hours to replace manual data entry and paper-based record keeping approaches. PIMS can also aggregate data from your existing or future data sources such as LIMS, MES, EBR and Historians.

Services include:

  • System Configuration
  • Design, development and testing of manufacturing process maps
  • Validation and execution
  • User training

DATA MIGRATION

Most companies have extremely valuable historical process development and batch information stored on paper or in spreadsheets. This data store grows in size and value as drug products advance through the clinical trial process. However, delays in adoption of digital data management and analytics creates an increased reliance on manual data entries and transfer and also creates unnecessary risk of error. Skyland Analytics can assist in migrating this data into the Skyland PIMS digital platform in order to provide more robust and representative data sets for analysis.

DISCOVERANT® SERVICES

If you are looking to purchase, implement, or obtain training on Discoverant process management software, engage Skyland Analytics.

Our key people are some of the original developers of Discoverant and have over 15 years of successful deployment and training in leading emerging companies and global giants such as AbbvieBaxaltaBiogenBioMarinBMSEli LillyMerck KGaA and Shire.

We understand cGMP, 21 CFR Part 11, software validation and CPV principles and practices and have experience with a broad range of statistical software applications including JMP, SAS, Matlab, Minitab, Camo, Umetrics SIMCA, Smartlab, Sample Manager, Empower, Oracle, SQL Server and OSIsoft PI (and other historians) in addition to Discoverant.

  • Implementation and Configuration of Discoverant
  • Design, Development and Testing of Discoverant Hierarchies
  • Design, Development and Testing of PRIMR
  • Validation Planning and Execution
  • Design and Setup of Monitoring Programs
  • User and Hierarchy Development Training