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Ensure Data Integrity of Printed Documents with Scilife

Keep paper under control, and ensure data integrity and a spotless
audit trail

Agenda

 

02:10
Main challenges with printing and reconciling

13:50
Scilife's approach to Print & Reconciliation


14:38

Print & Reconciliation Case Study  in Scilife 

48:30
Q&A Session

In this free session, you’ll see a practical demonstration of how Scilife’s Print & Reconciliation solution works, you’ll learn how to use the barcode system, how to set up an approved printer network to have control over your prints and follow data integrity and 21 CFR Part 11 requirements

Q&A's from the session

Can you identify in the printed copies what reprint it is?

Yes, absolutely. The printed copies contain metadata including the date, time, and reprint number. This information is automatically printed on the paper along with the barcode at the bottom of the page and can also be viewed within the Scilife platform's audit trail.

 

Can this Print and Reconciliation solution work on its own?

The print and reconciliation module can work on its own. You can print from any source and reconcile in this platform without needing to integrate with another document management system or an ERP.

 

Who is normally in charge of the configuration and qualification of printers or barcode scanners?

The responsibility for the configuration and qualification of printers or barcode scanners varies. It can be the IT department, business users, or engineering department, depending on the organization's structure and policies.

 

Is it required to maintain a manual system as part of disaster management in case the electronic system is down?

It is important to note that the digital system is designed to replace the manual system. However, it is essential to conduct a risk assessment to determine the appropriate course of action in case of system failure.

When choosing a vendor or a solution for process digitization, the risk assessment will inform the actions to be taken. It may be necessary to ensure access to data in case of system failure, but having a full manual system as a backup is not recommended.

Ultimately, each company should make its own decision based on its unique needs and circumstances. However, it is not an ideal approach to rely on a manual system as a backup for digital systems.

 

What information from the documents is stored in Scilife?

Scilife doesn't store any information from the actual document. It's important to understand that. However, the Scilife print reconciliation solution does require certain data for the actual reconciling of the system. This includes information such as batch number, product name, and ID of the master document. Sensitive data is kept out of the system, so you don't need to worry about any critical information being stored within Scilife.

It's worth noting that if you're using Scilife document control, it's a different story. With Scilife document control, you not only store your documents but also create them and fulfill all the stages. However, the advantage of the Scilife print reconciliation solution is that it doesn't capture any sensitive information unless you require it to. So, you can be assured that your sensitive data is kept safe and secure.

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