MANUFACTURING INFORMATICS

Effective use of manufacturing data is necessary to meet FDA guidelines for Continued Process Verification (CPV) and Quality Metrics. Data-driven decision-making also increases ROI on process improvements, cuts the time and cost of technology transfer, reduces cycle time and improves yield. We offer a range of manufacturing informatics services that will improve the way you aggregate and analyze data to achieve your goals:

  • Informatics Software Search & Selection
  • Informatics Software Implementation & Training
  • CPV Program Design & Implementation
  • Manufacturing IT Architecture
  • Outsourced Analytics

MANUFACTURING RISK MANAGEMENT

As contract manufacturing becomes more widespread and process complexity increases, Life Science manufacturers face growing operational risks and greater scrutiny from the FDA and SEC. Identify and manage these risks through a Manufacturing Risk Assessment. Contact us for more information.

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
  • CPV using Discoverant
  • User and Hierarchy Development Training
  • Outsourced Analytics