SOP Training Management
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.
|Type of Project:||Software|
|Validated:||UAT, IQ, OQ|
|MS SQL Server|
Since this application was successfully validated, this client has engaged Innovative to produce additional quality solutions.