We are working with MassHunter 11.0.221.01 Networked Workstation that operates our qTOF 6546 instrument - Our laboratory works in regulatory environment (GMP). Networked Workstation should generates the following records that can be viewed and printed.
One of our problems concerns method acquisition version and its accessibility.
When the acquisition method is created and it is saved it gets its own version eg. 001. Any changes introduced to the saved method results in next version of the method eg. 002. The question is how it is possible to open former version of method? When we try to open method file that is in results data folder we get an error. Problem described above drives us to the situation than we cannot print or viewed the former version of the method that is inconsistent with regulation of 21 CFR 11 and Annex 11.
Our second concern concerns reports of analysis and methods.
On the report, the name and the path of the acquisition method is visible but there is no information about its version. Is there any way to include version of the method (acquisition and processing) to the report template with the results that is editable in ReportBuilder?
Report of acquisition method - AcqMethodReport shows the version of the method, however it is saved in *.rdlc format file and it is not editable in report builder.
Report of the processing method that is generated in Mass Hunter Quantitative also does not include the version of the method. Is there any way to modify the template of the processing report (*. rdlc file) and make the version method/batch visible on the report?
Thanku you for any help,