September 26, 2014

SOP Training Management

SOP Training Management

SOP Training
Small-to-mid-sized life sciences companies have most of the same regulatory needs as their larger peers, but are acutely sensitive to the cost of compliance.  Our sponsor came from a very large biotech company to assume the Director of Quality position at a growing Boston-area biotech with over 50 employees.  He sought a solution that would allow:

  • Managing SOP life cycle
  • Defining training courses
  • Managing training curricula
  • Setting up training classes
  • Managing training records
  • Reporting training status for managers and employees
  • Reporting SOP training status for managers and employees

We started with requirements gathering: the client emphasized that intuitive operation and low maintenance burden were critical to success.  Innovative delivered a secure solution with an Internet Explorer interface and 21 CFR 11 compliant application framework built on .NET/C# and MS SQL Server 2008.

PROJECT THUMBNAIL
Client:Confidential
Type of Project:Software
Scope:SOP/Training
21CFR11:Yes
Validated:UAT, IQ, OQ
Platforms:MS IE6.0,
ASP,
NET/C#,
MS SQL Server

Since this application was successfully validated, this client has engaged Innovative to produce additional quality solutions.

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