Document Control Module

The Document Control module in LuitBiz QMS provides complete control over quality documents throughout their entire lifecycle—from creation and approval to distribution and archiving.

Define Document Types & Access Controls

Quality managers can define multiple document types including SOPs (Standard Operating Procedures), work instructions, quality manuals, specifications, test methods, batch records, and regulatory submissions. For each document type, administrators can configure:

* Who can request documents

* Who has authorization to create/write documents

* Approval hierarchies and review workflows

* Retention policies and archival rules

Document Request & Creation Workflows

When users need new quality documents, they can submit requests through the system. The quality manager reviews these requests and assigns them to authorized document writers. The document creation workflow includes:

* Automated routing to designated authors

* Email notifications for pending requests

* Status tracking (draft, under review, approved, published)

* Configurable approval chains with multiple reviewers

Document Templates & Standardization

Quality managers can create and maintain standardized document templates that ensure consistency across all quality documentation. Templates include pre-defined sections, formatting, headers, footers, and mandatory fields that authors must complete.

Approval Workflows

LuitBiz QMS supports multi-level approval workflows where documents route automatically to designated reviewers and approvers based on document type and organizational hierarchy. Features include:

* Electronic signatures with 21 CFR Part 11 compliance

* Sequential approval routing

* Rejection with comments and redlining

* Automatic version numbering

* Complete audit trail of all approvals

Document Publishing & Distribution

Once approved, the quality manager publishes documents to the controlled document library. Published documents become available to authorized users with appropriate permissions.

Controlled Copy Management

Users can download controlled copies of published documents directly from the system. LuitBiz QMS maintains detailed tracking of:

* Who downloaded each document

* Date and time of download

* Document version downloaded

* Training completion status linked to documents

This controlled copy tracking ensures that quality managers always know which users have access to which document versions - critical for regulatory audits and compliance verification.

Transform Quality Documentation Management with LuitBiz QMS Document Control

LuitBiz QMS Document Control eliminates paper chaos and compliance risks for pharmaceutical, manufacturing, and healthcare organizations by centralizing your entire quality document lifecycle in one powerful platform.

=> For Pharmaceutical Companies: Maintain FDA 21 CFR Part 11 compliance with electronic signatures and complete audit trails for drug development documentation, clinical trial protocols, and regulatory submissions.

=> For Manufacturing Operations: Achieve ISO 9001 certification faster with streamlined control over SOPs, work instructions, product specifications, and quality control procedures - ensuring consistency across production lines.

=> For Healthcare Providers: Protect patient confidentiality while managing medical records, treatment protocols, and HIPAA-compliant documentation with role-based access controls.

Quality managers gain complete control from document creation through archival. Automated workflows route requests to authorized writers, while standardized templates ensure consistency. Multi-level approval processes accelerate reviews while maintaining full audit trails.

Advanced controlled copy tracking shows exactly who downloaded which document versions - eliminating guesswork during audits. Reduce document-related deviations by up to 60% while accelerating approval cycles across your organization.

Process Control Module

The Process Control module empowers quality teams to manage quality events, investigations, and improvement activities through configurable quality forms and automated workflows.

Define Quality Forms

Quality managers and quality team members can define various types of quality forms to manage different quality processes:

=> CAPA (Corrective and Preventive Actions): Document and track corrective measures for quality issues and preventive strategies to avoid recurrence

=> Change Control: Manage changes to processes, procedures, equipment, or specifications with impact assessments and approval workflows

=> Deviation Management: Record, investigate, and resolve deviations from established procedures or specifications

=> Complaint Management: Track customer complaints, internal quality issues, and supplier non-conformances

=> Non-Conformance Reports (NCRs): Document product or process failures that don't meet quality standards

=> Risk Assessments: Evaluate and mitigate quality risks

=> Internal Audit Forms: Plan and execute quality audits with findings documentation

Each form type can be fully customized with specific fields, data validation rules, and mandatory information capture.

Link Forms to SOPs

Quality managers can publish quality forms and link them to relevant Standard Operating Procedures (SOPs). This ensures that when users access a quality form, they can reference the associated procedures, maintaining consistency between quality processes and documented procedures.

User Form Completion

Authorized users across the organization can access and complete quality forms based on their roles and permissions. The form interface guides users through:

* Required field completion with validation

* Attachment of supporting documents and evidence

* Automatic timestamp and user identification

Workflow-Based Approvals

Once a user submits a completed form, LuitBiz QMS automatically routes it through the approval workflow defined by the quality manager. The workflow includes:

* Multi-stage review and approval process

* Automatic notifications to reviewers and approvers

* Email alerts for pending actions

* Comment threads for collaboration

* Electronic signature capture at each approval stage

Approvers can review form details, request additional information, approve, or reject the submission with comments and attached documents.

Form Implementation & Action Items

After all required approvals are obtained, the form initiator receives notification that they can proceed with implementation. The implementation phase includes:​

=> Action Item Definition: Break down the approved form into specific action items or tasks

=> Responsibility Assignment: Assign each action item to specific individuals or teams

=> Target Date Setting: Establish deadlines for each action item

=> Progress Tracking: Update status as work progresses (Not Started, In Progress, Completed)

=> Evidence Documentation: Attach completion evidence such as photos, test results, or updated documents

=> Implementation Notes: Record details of actions taken

Users can track their assigned action items through personal dashboards and receive automated reminders for approaching deadlines.

Quality Department Closure

Once all action items are completed and implementation is verified, the initiator submits the form to the quality department for final closure review. The quality team:

* Reviews all completed action items and supporting evidence

* Verifies effectiveness of implemented corrections

* Ensures all documentation is complete

* Approves form closure with electronic signature

* Archives the closed form with complete audit trail

Closed forms remain accessible for reporting, trending analysis, and regulatory audits.