Controlled Printing & Reconciliation

Scilife's Controlled Printing & Reconciliation software is a module within the Scilife QMS designed to help life sciences organizations maintain full control over printed documents and forms. Built to be fully compliant with FDA 21 CFR Part 11, it addresses one of the most persistent regulatory challenges in regulated industries: ensuring that every printed page can be tracked, identified, and reconciled quickly and accurately.

Managing who prints what is only part of the challenge. The real complexity lies in collecting and reconciling every document when an audit occurs — a single missing sheet can cause delays or even total compliance failure. Scilife's Print and Reconciliation solution tackles this by combining seamless application connectivity, automatic audit logging, and barcode-based reconciliation into a single, centralized module.

Print Tracking & Audit Trail

• Issue printouts directly from any of your existing applications, with cross-functionality enabled without the need for complex integrations.
• Every print action is automatically logged in a central location, capturing who printed what and when.
• The module automatically recognizes reprints, ensuring the audit trail remains complete and unambiguous at all times.

Document Reconciliation Capabilities

• During printing, each page is automatically tagged with a unique identifier barcode, enabling precise tracking at the individual page level.
• Scanning barcodes within the Scilife Print and Reconcile solution instantly reconciles paper forms and documents, and the system immediately flags any missing documents or pages.
• Issues can be logged with comments directly on individual items, maintaining full traceability throughout the resolution process.
• Printed forms and documents can be grouped together, allowing users to view the reconciliation status of an entire document package — such as a specific batch — at a glance.

Issue Management

• The module supports rapid identification of and response to any reconciliation issues that arise.
• Teams can coordinate quick resolutions while keeping a clear, traceable record of all actions taken and comments logged against each issue.

Scilife's Controlled Printing & Reconciliation module is part of a broader Quality Management System platform, with offices in Brussels, Belgium and New York, USA. The solution is purpose-built for regulated industries requiring strict document control and audit readiness in line with FDA 21 CFR Part 11 requirements.