GxP
GxP Documentation
Control document access, revisions, reviews, approvals, and traceability throughout the document lifecycle.
Manage regulated documents with controlled workflows, version control, approvals, distribution, and audit trails for pharmaceutical, CRO, preclinical, and laboratory teams.
Zentixs Docs is a life sciences document management system (DMS) for creating, reviewing, approving, controlling, distributing, and archiving regulated GxP documents. Built for pharmaceutical, biopharmaceutical, CRO, and laboratory organizations, it provides version control, audit trails, access controls, and compliant document workflows.
A structured and compliant approach to managing controlled documents from initial preparation through final archival.
Create controlled documents using standardized templates, structured content, unique document identifiers, version controls, and mandatory metadata to establish consistency across the document lifecycle.
Initiate configurable document workflows with defined ownership, document classification, reviewer assignments, approval hierarchies, and lifecycle requirements aligned with established quality procedures.
Execute structured review workflows with role-based routing, documented comments, revision tracking, and traceable review histories to support procedural accuracy and quality oversight.
Execute authorized digital signing workflows with signer authentication, timestamps, and traceable signing records to establish document authorization and maintain the integrity of approval processes.
Link controlled documents to personnel training workflows, assign training based on document applicability and user roles, and track completion, assessment outcomes, and training effectiveness in accordance with defined procedures.
Release approved documents through controlled issuance workflows, manage effective versions, and distribute documents according to role-based access permissions, document applicability, and effective date requirements.
Manage controlled copy reconciliation, document withdrawal, superseded version replacement, and recall activities to minimize the risk of obsolete or unauthorized documents remaining in operational use.
Archive superseded and obsolete documents with preserved version histories, lifecycle records, access controls, and retention configurations to support audit readiness, regulatory inspections, and authorized retrieval.
Manage the complete document lifecycle through structured workflows, controlled distribution, revision traceability, and centralized governance for regulated life sciences documentation.
Standardize SOPs, STPs, protocols, batch manufacturing records, and quality documents using predefined templates, structured metadata, and controlled formatting.
Maintain a centralized, searchable repository for GxP documents, quality records, laboratory procedures, and controlled documentation across departments.
Enforce role-based permissions for document creation, review, approval, modification, distribution, and retrieval to protect sensitive quality information.
Maintain document version histories with traceable revisions, change records, approval status, and access to superseded versions.
Schedule periodic document reviews, assign review responsibilities, and track completion to maintain document accuracy and procedural relevance.
Track controlled document copies through registers or barcode-based identification, supporting issuance, reconciliation, withdrawal, and recall.
Find documents using metadata, document identifiers, keywords, classifications, and indexed content to accelerate access during audits, inspections, and daily operations.
Preserve obsolete and superseded documents with historical versions, retention controls, and authorized retrieval to support long-term record preservation and audit readiness.
Trigger configurable notifications for pending reviews, approval tasks, upcoming review dates, document expiry, training assignments, and overdue actions.
Zentixs Docs supports the document types used across pharmaceutical, CRO, preclinical, and laboratory operations.
Manage controlled documents used across manufacturing, quality,
validation, laboratory, and regulatory functions.
Zentixs Docs uses AI to assist users with document understanding, drafting, comparison,
and information discovery while keeping document approval under human control.
AI Document Summarization generates concise summaries of lengthy SOPs, protocols, procedures, and other controlled documents, helping users quickly identify key information and improve document review efficiency. The original document remains the authoritative controlled source, while AI-generated summaries support faster understanding without replacing the approved document.
AI SOP Generation uses artificial intelligence to create structured draft Standard Operating Procedures (SOPs) from user-provided information, requirements, and prompts, helping streamline document preparation. AI-generated SOP drafts remain subject to review, revision, approval, and document control by authorized personnel before becoming controlled documents.
AI Version Compare uses artificial intelligence to identify and highlight differences between versions of SOPs, protocols, forms, and other controlled documents, supporting document review and revision management. It helps users quickly identify changes while keeping the organization’s established document control, review, and approval processes as the authoritative workflow.
AI Keyword Search enables users to find relevant SOPs, procedures, records, and other controlled documents using keywords, contextual terms, and document content rather than relying solely on exact document names or folder locations. AI-assisted search improves information discovery across the document repository while allowing users to access and verify the original controlled documents.
Zentixs Docs provides a structured document lifecycle — from creation and review through approval, issuance, and compliant archival — all in one controlled environment.
Compare current and previous versions of SOPs, protocols, procedures, forms, and other controlled documents to identify revisions before approval.
Review changes between document versions to understand what has been added, modified, or removed during the document revision cycle.
Use AI-assisted document comparison to help identify and highlight differences across document versions, supporting faster and more focused review.
Use version comparison as part of the controlled document review process while authorized users retain responsibility for final review, approval, and release.
Maintain complete document traceability with controlled revisions, documented approvals, and reliable access to records throughout the document lifecycle.
Maintain controlled evidence of regulated activities and documentation.
Track document revisions and maintain historical versions.
Record reviews, approvals, and document status.
Manage document access through defined permissions.
Quickly retrieve records during audits and inspections.
Demonstrate document history and control throughout the lifecycle.
Keep critical documents organized, & readily retrievable for audits & inspections.
Manage creation, review, approval, issuance, revision, recall, & archival in one system.
Reduce the risk of outdated, duplicated, or uncontrolled documents across teams.
Find approved documents, records, and document history faster when needed.
A structured approach to controlled documentation, traceability, and data integrity across the document lifecycle.
Zentixs Docs supports electronic record controls through controlled access, document history, audit trails, and traceable user actions. Suitability for applicable Part 11 requirements depends on system configuration, validation, procedures, intended use, and applicable predicate rules.
Control document access, revisions, reviews, approvals, and traceability throughout the document lifecycle.
Manage manufacturing SOPs, specifications, testing procedures, quality records, forms, and reports.
Organize laboratory SOPs, study plans, reports, and laboratory records with controlled revisions and approvals.
Manage clinical protocols, informed consent documents, study forms, and clinical records through controlled workflows.
Support data integrity through traceable user actions, document history, and controlled document workflows.
Support controlled GMP documentation, including review, approval, distribution, revision, retention, and retrieval.