Manage Controlled Documents

The Document Management interlinked module gives you the upper hand on SOPs, protocols, specifications, quality agreements, audit reports and more. It helps you manage documents types/formats and setup and track reviews & approvals.

FEATURES

Review and Approval Process

You can create your review team, send documents for review and monitor comments. The team can also access the comments, post their own and read a summary of changes between revisions. 21CFR Part 11 compliant e-signatures are embedded in the application.
You can e-route your documents for approval in series or in parallel to the appropriate authority under a 21CFR Part 11 validated system. No more lost documents, visibility issues, or people being unclear about due dates and expectations.

Document Cross-referencing

Create a family of documentation and gain an upper hand on modifications. When a change is made within the "family of documents", tasks are sent out to the owner to evaluate impacts.

Automated Traceability

Traceability is the number one source of tension during audits and certainly a major indication of a healthy GxP system. With SOLABS QM system traceability is automated via e-audit trails and information is available in real-time.

Distribution & Security

Document distribution is automated based on roles and effective dates. Visibility is controlled by SOLABS QM, guaranteeing that the right people have the current version. Documents are published in a non-editable format (PDF).

Document Search Engine

SOLABS’ comprehensive search engine is consistent with security privileges. Search can be made across the system information, such as a particular document’s attribute, information within a document, training record, task and more.

Review Date Management

You can automate the period at which a document is up for review and decide the appropriate accountability. The system will then automatically let you know which documents are out of compliance.

Document Types

Set-up and control multiple document types under one integrated system: COA, SOP, Validation Protocols, Batch Master Sheets, Training Sheets, Specifications and more. There is no limit to the number of GxP document types you can configure.

Interface & Language

SOLABS QM system’s interface and language are "GxP friendly". Developed in Java (J2EE), the QM platform can take on the language of any operating systems, thus providing a multilingual solution. It can also be configured to run with both Oracle and SQL server.

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