Hi All,
I was hoping for some insight regarding TotalChrom. I should preface this with saying I am completely new to chromatography, outside of some basic Empower knowledge and what I did in college. My focus is to ensure data integrity of the software, so setting proper JobType permissions, mapping the locations of result files, ensuring audit trails are enabled, and other things of that nature. I work in a regulated QC environment that utilizes TotalChrom with the Perkin Elmer Flexar HPLC. My questions are as follows:

1) Currently, our result (.RST) and raw (.RAW) data files are saved to the (C:) drive of Window’s explorer. With a bit of exploration, it seems as though these files can easily be deleted, whether accidental or intentional. If these files are deleted, would anyone know? What safeguards can be established to avoid file deletion? Finally, if deletion occurs, is the file gone forever (we do not have a data archival procedure in place yet)?

2) How do I locate result audit trails? I am able to locate the audit trails for methods, sequences, and report files, but nothing for results. I know that auditing for a result file is automatically enabled if any of the methods used to create the result file have auditing enabled. From what I see, test runs are performed utilizing methods that have audit trailing enabled. Analysts modify old sequences and save as for new runs. Piggybacking off of my previous question, are there any identifiers to indicate manual integration/data reprocessing? I know with Empower, you can easily identify manual integrations with peak labels. We do not use manual integration often as automatic integration is effective almost all of the time, but every once in awhile the need does arise.

Sorry for the wordiness, I just wanted to make sure that I provided as much detail as possible. Please let me know if I can provide any additional info. Thanks!