Configuring Document Types and Categories
Navigate to Document Management > Setup > Document Types to define your document classification structure. Standard categories include procedures (QP), work instructions (WI), forms (FM), specifications (SP), and external documents (EXT). Each document type specifies default retention periods, review cycle intervals, and required approval roles.
Configure storage locations under Document Management > Setup > Storage Locations to define whether documents are stored in the SyteLine database, a network file share, or a linked SharePoint library. Set naming conventions using the Document Numbering form to enforce consistent document identification across the organization.
- Define document types (procedures, work instructions, forms, specs) under Document Management > Setup > Document Types
- Set default retention periods and periodic review intervals (typically 12-36 months) per document type
- Configure storage locations for database, network share, or SharePoint integration
- Establish document numbering conventions with auto-increment and prefix/suffix rules
Managing Revisions and Approval Workflows
SyteLine's document revision control tracks every version with a revision number, effective date, and change description. Access the Document form via Document Management > Documents to create new documents or revise existing ones. When creating a revision, the system archives the prior version and routes the new version through an approval workflow.
Configure approval routes under Document Management > Setup > Approval Routes to define sequential or parallel approval chains with role-based approvers. Each approver can approve, reject, or request changes with electronic signature capture per 21 CFR Part 11. Rejected documents return to the author with reviewer comments for revision.
- Create and revise documents via Document Management > Documents with automatic version archiving
- Configure approval routes with sequential or parallel reviewer chains under Setup > Approval Routes
- Capture electronic signatures on approvals with timestamp, user ID, and approval meaning statement
- Set up email notifications for pending approvals, approaching review dates, and rejected documents
Controlled Distribution and Access Management
Controlled distribution ensures that only current, approved document revisions are accessible to authorized personnel. Configure distribution lists under Document Management > Setup > Distribution Lists to define who receives each document type by role, department, or work center. SyteLine marks superseded revisions as obsolete and prevents their use in production references.
Link controlled documents to operations, items, or quality plans so that shop floor users access the correct work instruction revision automatically. The Document Control Dashboard provides real-time status of documents pending review, awaiting approval, or approaching expiration dates.
- Define distribution lists by role, department, or work center for controlled document access
- Automatic obsolescence marking prevents use of superseded document revisions in production
- Link documents to routing operations and inspection plans for shop floor accessibility
- Monitor document status via the Document Control Dashboard, pending reviews, expirations, approvals
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SyteLine Change Request Form Template
A change control form for SyteLine configuration, customization, patch and integration changes with impact analysis and rollback plan.
Frequently asked questions
Does SyteLine document control meet ISO 9001 clause 7.5 requirements?
Yes, SyteLine's document control system addresses all ISO 9001:2015 clause 7.5 requirements for documented information. It provides controlled creation and updating with identification and description, review and approval for suitability and adequacy, controlled distribution and access, and protection against unintended alterations. The revision history and approval audit trail provide objective evidence of compliance during certification audits.
Can SyteLine manage external documents like customer specifications?
Yes, external documents are managed through the External Document type with special handling rules. SyteLine tracks the document source (customer, supplier, regulatory body), received date, and applicability to specific items or contracts. External documents follow a simplified approval workflow, typically acknowledgment of receipt and applicability review rather than full internal approval. The system alerts users when external documents are updated by the originator.
How does SyteLine handle document training acknowledgment?
SyteLine supports training acknowledgment through the distribution list and read-receipt functionality. When a new or revised document is distributed, assigned personnel receive notification to review the document and acknowledge via electronic signature. The Training Acknowledgment Report tracks completion rates by document and department, identifying personnel who have not yet acknowledged. This supports ISO 9001 clause 7.2 competence requirements and audit evidence needs.
Need to implement ISO-compliant document control in SyteLine? Netray helps manufacturers configure document management workflows that pass certification audits the first time.