The development of new products or their modifications is a manufacturing process in which all the different departments play a part (for example Development, Quality Control, Marketing, Controlling). GUS-OS Product Pass controls and documents all these procedures. The web based solution allows all involved parties in distributed work centers to be included (for example external laboratories or subsidiaries). The application-integrated workflow allocates tasks (Todos) to individual user groups and consolidates them into specific user group task lists. From there the relevant application can be called by mouse click – for example GUS-OS Laboratory for material specifications.
The documentation of all tasks, documents and data is carried out in accordance with the regulations for 21 CFR Part 11. This means that all data entries and changes are stored and can be traced at any time. The application-integrated workflow management gives, at any time, a current synopsis of open tasks or of tasks that have been carried out. Individual process steps are displayed in a procedure plan and the status of each process step has been color coded. The procedure plan is also displayed in table form with the status of each process step. Finally – if required – every released process step can be given an electronic signature.
All the relevant documets for the process are managed in a document list – for example:
- Specifications
- Incoming goods forms
- Construction drawings
- Review control
- Certificates – and
- Releases
With the closure of a process all data and process information are converted into XML so that the requirements for 21 CFR Part 11 are fulfilled. "Electronic records have to be printable, readable for people as well as electronically and be retrievable at any time during the storage period."
