Validation-Ready
CSV package included with every deployment
Complere provides structured validation documentation — VMP, URS, risk assessment, IQ/OQ/PQ templates, and periodic review guidance.
Regulatory Compliance
Built for Regulatory Compliance
Validation, data integrity, and regulated controls — in one hub
This hub focuses on what auditors and IT security reviews ask for: CSV/CSA and qualification evidence, ALCOA+ data integrity and audit trails, Part 11 electronic records and signatures, and enterprise security. Operational change is governed too — see how change control ties releases to linked documentation, training, and re-qualification decisions.
Key Benefits
How this module improves quality operations, reduces compliance risk, and supports inspection readiness for regulated teams.
ALCOA+ Aligned
Every record is attributable, accurate, and retrievable
Time-stamped audit trails, user attribution, and protected record history support data integrity expectations across all modules.
Part 11 Aligned
Electronic signatures with re-authentication and intent
Complere enforces signature meaning, identity confirmation, and record linkage for every governed workflow action.
Workflow Overview
How Complere supports the workflow
Each step in this workflow is supported by governed records, electronic signatures, and a full audit trail — so quality operations stay traceable and inspection-ready.
01
Identify your regulatory framework
FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, or ALCOA+ — Complere addresses each framework specifically, not generically.
02
Review the relevant platform controls
Each compliance domain maps to specific platform capabilities — validation support, audit trail architecture, signature model, or access management.
03
Go deeper with guides and glossary terms
Long-form compliance guides, regulatory playbooks, and glossary definitions help your team prepare for due diligence and supplier assessment conversations.
04
Validate fit with a guided demo
A 45-minute compliance-focused demo covers your specific frameworks, controls, and validation questions with a product specialist.
Platform Capabilities
The specific controls, features, and workflow functions built into this module to support your quality and compliance objectives.
Computer System Validation
Validation Approach
Understand how Complere supports risk-based validation with a structured CSV package — VMP, URS, IQ/OQ/PQ, and lifecycle review materials included.
Read the validation approachALCOA+ Data Integrity
Data Integrity & Audit Trails
Every action in Complere produces a time-stamped, user-attributed audit trail. Records are protected, readable, and retrievable for regulatory inspection.
Review data integrity controlsFDA 21 CFR Part 11
Electronic Records & Signatures
Complere enforces re-authentication before each signature, captures intent and timestamp, and links every signed action to its full record history.
See Part 11 records and signaturesSecurity & Privacy
Security & Privacy
Role-based access with 210+ configurable permissions, 2FA, SSO support, tenant-level database isolation, and GDPR-compliant data controls.
Review security and privacy scopeCloud Controls
GxP Cloud Software
Review how validation, data integrity, hosting region, and supplier oversight fit together when the quality system runs in a managed cloud environment.
Read the GxP cloud software guideBuyer guides by framework. Best eQMS for 21 CFR Part 11 · FDA QMSR · ISO 13485. See what ships in the CSV + CSA validation pack.
Ready to review how Complere handles your compliance requirements?
Walk through validation documentation, signature controls, and data integrity posture with a Complere compliance specialist.