EMEA Office
Louizalaan 489
1050 Brussels
Belgium
06:35
Introduction and key challenges
22:50
Print & Reconciliation Case Study
27:30
Solution to P&R
54:15
Q&A session
Many life sciences companies still require paper-based processes for certain operations in an increasingly digital age. This hybrid approach creates unique challenges for maintaining data integrity and regulatory compliance, especially regarding ALCOA+ principles. Managing printed documents while ensuring traceability and preventing unauthorized alterations is crucial for GMP compliance.
Join us for this free showcase to discover how Scilife's Print & Reconciliation solution helps you maintain data integrity, automate document tracking, and ensure regulatory compliance while working with paper-based processes in GMP environments.
Is document management linked exclusively to Word?
We have an integration with Microsoft Office that allows live editing of documents using local versions of Word or Excel. However, you can upload any file format directly into document control from your computer.
Can flowcharts be used as documents?
You can use any file type, including videos and images. While only Word and Excel documents can be live edited, all other document types can be processed through the workflow, signed electronically, and maintain a complete audit trail.
How scalable is the P&R solution for organizations managing high volumes of printed documents across multiple sites or departments?
The solution is highly scalable. The "groups" functionality helps manage access across different departments and sites. We have customers operating across 50 different sites in various countries. There's no limitation on document volume—you can work with documents hundreds or thousands of pages long. Some customers use the system with up to 9,000 simultaneous users.
How does the system ensure that only authorized personnel can print templates?
The P&R solution integrates with user access controls through group access management, where specific roles and rights are assigned to each group. The system maintains compliance with ALCOA+ principles through digital signatures and audit trails that record who accessed or printed documents, when, and what actions were performed.
How does the P&R solution identify missing pages and ensure compliance with ALCOA+ principles?
The solution uses barcode functionality to uniquely identify each page. During reconciliation, the system scans and validates barcodes against the original print job to detect discrepancies. Missing pages are immediately flagged, and a detailed audit trail records the reconciliation process to support compliance.
Can the Document Control solution identify and prevent the use of outdated templates?
The solution ensures only the latest approved template versions are available. The system maintains version control, archives outdated templates, and cross-references print job requests against the latest approved versions. Users are guided toward compliant actions through notifications and access restrictions.
How does the barcode functionality ensure traceability and accuracy during reconciliation? Can the system automatically flag errors or duplicates?
The system assigns unique barcodes to each page and tracks them throughout the document lifecycle. During reconciliation, these barcodes are scanned and verified. The system provides real-time alerts for errors, duplicates, or discrepancies, reducing human error and ensuring ALCOA+ compliance. Detailed reports are generated for auditing and regulatory purposes.
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
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