Why does the test location not show on the control printout?
When you’re conducting a control print with the Document Control Module, the test location is saved in the feature itself. This is done for every control print so that you can look up the location later on and make sure that control prints are destroyed after a new version of that document is implemented. However, the location is not printed on the document; it is simply stored in the print logs of the Document Control Solution and you can access it from there and see where it is located.
How do I see how many sheets were printed? For example, if I want to print page number two of a document and you want to print it twenty times, is there traceability to know you have printed it twenty times?
Yes, you can find this feature in the system menu. You can also configure if you want to allow multiple prints.
How do I prove that the Scilife system is compliant with 21 CFR Part 11?
This is actually one of the most important features: Scilife software is compliant with 21 CFR Part 11. For example, both username and password are needed to gain access to the system. Every action and every print are time-stamped, including which printer you have used and when, and if there is a reprint, there’s a reason given. Giving the reason why you have reprinted a document or why there is a missing page is very important.
Afterward, if there is a page missing, you know that maybe you will have to open a nonconformity or a deviation because pages cannot get lost unless there is a clear justification.
Remember that in case you have printed the copy, if you have the original copy, although it is damaged, you should keep it with your paper, unless it is fully destroyed. 21 CFR Part 11 also requires this.
Further, we validate the system to be compliant and to be fit for its intended use. We provide a full documentation about the validation of the tool, so you can use it for completing your internal qualification and validation and show it to your auditors when needed.
Can I deploy the Print & Reconciliation Solution in my production environment?
Yes. If you would like to activate the solution in a test environment, simply reach out to Trine Michelsen, our Customer Success Manager, and we will activate it for you to try it out. It can also be activated in the production environment.
Does the system require periodic requalification?
The way that Scilife works is that for every single Module, we have a new release. We have different types of releases: minor, medium, and major. Every time that we have a new medium or major release, you will see that we provide a full validation package for that specific release. And then it is up to you to define how much you want to go into detail, if you want to validate, or if you simply want to leverage off the full validation package that we provide.
How do I use audit trailing in document management?
The tool offers full traceability of the audit trail. Audit trails should be reviewed depending on your risk assessment. Some companies review the audit trail before approving a lot or a batch of medicinal products, for example. It depends on how critical it is according to your Risk Management System. If the document is not very critical, you could even establish a periodic revision, not before the approval of a lot, but every month, for instance. Overall, it depends on your policies and how you implement this in your SOPs.
Can I customize the information appearing next to the barcode?
Yes, you have a great deal of configurability here. When you create the different category types, you also set up the category tile itself. Then, you add as many fields as you need. And every time you add a field to that specific print category, you can select that this information should be printed next to the barcode.
