Solutions
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MANAGE CONTROLLED DOCUMENTS SOPs, Protocols, Specifications, Quality Agreement, Audit Reports, etc. |
Review and Approval Process
You can e-route your documents for approval either in series or in parallel to the appropriate authority under a 21CFR Part 11 validated system. You do not have to worry about documents getting lost, visibility issues, or people being unclear about due dates and expectations.
Create your review team, send documents out for review, and monitor comments. The rest of the team can see comments others have placed, post their own, and read a summary of changes between revisions. Monitor the review processes within projects for real time statuses, etc.
You can e-route your documents for approval either in series or in parallel to the appropriate authority under a 21CFR Part 11 validated system. You do not have to worry about documents getting lost, visibility issues, or people being unclear about due dates and expectations.
Fully 21CFR Part 11 compliant e-signatures embedded in the application. SOLABS contains additional quality steps beyond standard requirements. Also, you do not have to worry about changes to 21CFR Part 11 - our approach is to absorb those problems on your behalf.
Document Cross-referencing
Create a "family" of documentation and gain an upper hand on change control. When a change is made within the "family of documents", tasks are sent out to the owners of the relatable documentation to evaluate the impact more clearly. This facility enables maximum benefit to be achieved from corporate knowledge and enhances speed to market.
Traceability
Traceability is the number one source of nervousness during audits and certainly a major indication of a healthy GMP system. With SOLABS GMP, traceability is automated via e-audit trails and linking, and better yet, it ceases to be a cost center! Information is always available in real-time.
Distribution & Security
Document distribution is automated based on role privileges and effective dates. Visibility is controlled by SOLABS GMP, guaranteeing that the right people have the correct version at the right time. Documents are published in a non-editable format (PDF).
Document Search Engine
SOLABS ‘s comprehensive search engine is consistent with security privileges. Searching is possible across the system information e.g., documents' attributes, information within documents, training records, tasks, etc.
Review Date Management
Automate when a document is up for review with the appropriate accountability. Know your documents that are "out of compliance due to lateness", i.e. documents that should have been reviewed but have not. They are a FAVOURITE with the auditors!
Document Types
Set-up and control your multiple document types under one integrated system: COAs, SOPs, Change Control, Validation Protocols, Batch Master Sheets, Training Sheets, Specifications, CAPA, etc. There are no limits to the amount of GMP document types you can configure for your company.
Interface & Language
Since SOLABS is 100% Good-Manufacturing-Practice-focused, its interface and language is "GMP friendly". This has been validated with end-users. It can also adopt the language of operating systems, therefore providing an instant multilingual solution.