Consulting Services and Custom Software Development

Module 3 Solutions provides contract consulting services that span the entire software life cycle with a focus on Chemistry, Manufacturing, and Controls (CMC) data. Our specialties are data architecture, data harmonization and data quality, cGMP, HL7 FHIR and v3 data models, FDA CMC submission requirements, Laboratory Information Management Systems (LIMS) and statistical methodology for expiry dating. We provide our clients with our experience wherever needed, from the design and architecture stage through development and testing, to deployment and operation. We can build your software from scratch or work within an existing system.

Below you'll find a list of the general services we provide, as well as some of the areas in which we often work. We have a broad set of skills and experiences in software development within the life sciences domain. If you are unsure of whether our profile fits your task, don't hesitate to contact us.



Custom Database Connection to eStability Editor

  • Many pharmaceutical companies store their stability data in a LIMS. eStability Editor can be connected to a database and custom sql queries can load data into the Editor.
  • Save time re-entering and checking data that has already been entered.
  • Most LIMS will not have all the information required by the message. That information can be entered in the Editor after most of the data has been extracted from an existing database.
  • Your LIMs database(s) connected to eStability Editor will produce the final XML message, ready for the FDA.


Consulting Services

  • Pharmaceutical Quality/Chemistry, Manufacturing and Controls standardization impact assessment including current LIMS/database audit
  • CMC data harmonization for data standards, governance, and stewardship
  • CMC Submissions support by Regulatory Affairs Certified consultants
  • Data transfer specifications for integration from legacy LIMS/databases or Excel spreadsheets
  • Computer system validation
  • Product and implementation training


Scripting

  • We have years of script-building experience to help analyze your data.
  • Module 3 Solutions has developed the eStability stylesheet for the FDA.
  • We will write custom JMP Add-ins written in jsl. JMP (pronounced "jump") is a software product developed by SAS that performs a full range of statistical analyses. It is a data-visualization tool used by many pharmaceutical companies to calculate expiry times and perform control chart analysis.
  • Our specialties: stylesheets in XSLT that incorporate javaScript, XML, API design and development, and validation test scripts


Preferred tools and languages:

  • HL7 FHIR®
  • XML Technologies:XML, XSLT, XSL, HTML, CSS
  • Databases/Analytics: Oracle, MySQL, JMP, JDBC
  • Graphical/Web User Interface: Visual Studio.NET, WebMatrix
  • Languages: VB, C#, Pl/Sql, javaScript

Let Module 3 Solutions broad set of skills and experiences help your company evolve with its changing environment. Contact us today!