Organize documents through a structured category and sub-category framework with user-defined fields for cleaner segmentation and easier control across the organization.
E-Docs & Document Control | Spectrum QMS
Control the document. Simplify compliance
Spectrum’s E-Docs module provides a 21 CFR Part 11 compliant environment to manage documents from creation through review, release, revision, and retirement. Centralize controlled documents in one secure system where approvals are authenticated, workflows are traceable, and current versions remain easy to identify.
Dynamic Approval Workflows
Keep documents moving without losing control
Configure document workflows using serial or parallel approvals, define authorized stakeholders, and apply threshold and reminder settings to keep reviews progressing on schedule.
21 CFR Part 11 E-Signature Control
Authenticated approvals with regulatory discipline
Use secure electronic signatures (E-signature) with defined meanings and controlled user authority so each approval step is clearly assigned and properly documented.
Lifecycle and Version Management
One current version. Clear document history
Manage key document milestones including effective date, validity date, revision date, and review date. When a new version is published, previous releases are preserved in the system as part of the version history, helping teams work from the current authorized document with less confusion.
More reasons to switch with Spectrum
Category and Sub-Category Organization
Metadata-Based Document Retrieval
Use document metadata, keywords, document class, department, category, and other defined attributes to quickly locate the right file as your controlled document library grows.
Secure Release Management
Apply an authorized release step before publication, with the ability to cancel or revoke releases when needed using the relevant user and document ID, supported by detailed justification for full traceability and control.
Workflow Reassignment
Reassign a document workflow to another authorized user when responsibilities shift, helping keep approvals moving without breaking the controlled process.
Authority-Based Access
Define clear user roles to control who can add, edit, release, approve, or view documents, ensuring sensitive records remain secure, compliant, and accessible only to authorized personnel.
Document Inquiry
Generate a complete inquiry view for any document, providing access to its current details, status, and all related information in one centralized place for better visibility and control.
Traceable Compliance History
Operate in a 21 CFR Part 11 compliant environment where document actions are supported by a defensible history of review, release, and change activity.
FAQ
Frequently Asked Questions
Yes, Spectrum’s E-Docs module is designed to support 21 CFR Part 11 compliant document control. Documents follow a controlled lifecycle from creation, review, approval, and publishing, with secure access control, electronic signatures, regulated workflows, and complete auditable logs maintained at every stage.
Yes, Spectrum allows you to define category-based workflows with serial or parallel approval structures based on document type. Access can also be controlled from group level to individual user level, ensuring only authorized personnel can view, edit, review, or approve documents, with complete audit logs maintained for every action.
Spectrum follows a structured document revision process aligned with your company’s approved document management procedure. When a document is updated, it moves through the required review, approval, and publishing workflow before becoming a new effective version. The system tracks revision dates, version numbers, approval history, and preserves previous versions for complete traceability and historical reference.
Yes, Spectrum’s QMS tracks review-related dates and supports threshold and reminder settings to help document owners act before records become outdated.
Authorized users can use the Cancel Release function with the relevant document ID to stop that release in a controlled manner
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Testimonials
What They Say About Us
A reliable partner for smarter laboratory management.
Working with Sofcom has been a rewarding experience. Spectrum has proven to be a valuable solution for managing laboratory operations, helping us improve data analysis and support better decision-making.
I look forward to Sofcom’s continued innovation and the positive impact their solutions will have on the pharmaceutical industry.
