Skip to main content

Platform

Platform Overview

One connected quality system for your entire operations

Modules covering document control, CAPA, audits, training, change, risk, management review, and more — sharing one audit trail, one permission model, and one validation posture.

See the full platform

Platform

Platform Overview The connected eQMS foundation. Compliance Intelligence Regulatory context inside workflows. Dashboards & KPIs Executive visibility across events and actions. Modules Hub Explore the module landscape.

Rollout

Pilot Approach Start with one workflow and expand from a proven base.

Modules

Document Control Lifecycle control for SOPs, forms, and approvals. CAPA & Deviations Issue management from intake to effectiveness verification. Audit Management Internal, supplier, and site audit programs in one flow. Training & Competency Controlled training records and competency sign-off. Change Control Impact-assessed change governance with approval chain. Risk Assessments Scored risk records linked to CAPA, change, and audits. Management Review KPI dashboards and cross-module leadership visibility. Audit Confidence Maintain inspection-ready proof across all quality records.

Solutions

Transformation Journeys

Meet teams where they are today

Choose a path based on your current-state challenge — replacing paper, Excel, or legacy systems — or by the quality outcome you need to achieve.

View solution pathways

Transformation Journeys

Paper-Based to Digital QMS Replace manual paper quality systems with governed digital workflows. Excel to Controlled Workflows Move from spreadsheet quality tracking to auditable controlled records. Legacy eQMS Replacement Migrate from expensive or hard-to-adopt legacy quality platforms. Multi-Site Standardization Unify quality operations and standards across multiple sites.

Operational Outcomes

Audit Readiness Maintain inspection-ready quality records at all times. Quality Visibility Real-time leadership oversight across quality events and metrics. Process Accountability Assign, track, and close quality actions with full ownership. End-to-End Traceability Link documents, events, CAPAs, and changes in one traceable system.

Industries

Industries

Quality management built for your regulated market

Complere is configured for the regulations, workflows, and compliance expectations of each industry — not a generic platform stretched to fit.

Browse industries

Regulated Industries

Pharmaceutical Manufacturing GMP, Part 11, and Annex 11 controls for pharma quality operations. Medical Devices ISO 13485 and ISO 14971 quality management for device manufacturers. Healthcare & Laboratories Quality governance for clinical, diagnostic, and laboratory environments.

More Industries

Nutraceuticals & Supplements GMP quality controls for supplement and nutraceutical manufacturers. CMO / CDMO Multi-site quality operations for contract manufacturing organizations. Clinical Research & CROs GCP-aligned quality controls for clinical research organizations.

Compliance

Regulatory Compliance

Built to satisfy validation, data integrity, and records requirements

Complere aligns with FDA 21 CFR Part 11, EU GMP Annex 11, ISO 13485, and ALCOA+ data integrity expectations out of the box.

Explore compliance proof

Compliance Topics

Validation Approach CSV methodology, qualification evidence, and lifecycle governance. Data Integrity & Audit Trails ALCOA+ data integrity posture and time-stamped record history.

Controls

Electronic Records & Signatures Part 11-aligned e-signature, re-authentication, and audit linkage. Security & Privacy RBAC, 2FA, SSO, tenant isolation, and GDPR data controls.

Resources

Resources

Practical resources for quality and compliance teams

Guides, templates, blog articles, FAQs, and glossary terms to help regulated teams evaluate, implement, and operate Complere.

See the resource hub

Articles & Guides

Resources Hub All guides, articles, templates, and glossary content in one place. Blog Quality and compliance insights for regulated life-sciences teams. Compliance Guides In-depth regulatory playbooks covering Part 11, Annex 11, and more. Checklists & Templates Downloadable templates to support regulated quality operations.

Help & Reference

FAQs Quick answers to common questions about Complere, rollout, and compliance. Glossary Plain-language definitions of quality and compliance terminology.

Company

Company

Learn about Complere and start a conversation

Find out who we are, how we work with regulated teams, and how to take a first step — whether that is a demo, a pilot, or just a conversation.

Visit company pages

Company

About Story, team, and operating principles. Contact Form-led contact page. Careers Hiring and culture.

Commercial

Legal Policy and agreement hub. Pricing Packaging and rollout options. Request Demo Primary conversion route. Start Pilot Phased rollout request page.

Request Demo

Platform

One connected quality system for your entire operations Platform Overview Compliance Intelligence Dashboards & KPIs Modules Hub Pilot Approach Document Control CAPA & Deviations Audit Management Training & Competency Change Control Risk Assessments Management Review Audit Confidence

Solutions

Meet teams where they are today Paper-Based to Digital QMS Excel to Controlled Workflows Legacy eQMS Replacement Multi-Site Standardization Audit Readiness Quality Visibility Process Accountability End-to-End Traceability

Industries

Quality management built for your regulated market Pharmaceutical Manufacturing Medical Devices Healthcare & Laboratories Nutraceuticals & Supplements CMO / CDMO Clinical Research & CROs

Compliance

Built to satisfy validation, data integrity, and records requirements Validation Approach Data Integrity & Audit Trails Electronic Records & Signatures Security & Privacy

Resources

Practical resources for quality and compliance teams Resources Hub Blog Compliance Guides Checklists & Templates FAQs Glossary

Company

Learn about Complere and start a conversation About Contact Careers Legal Pricing Request Demo Start Pilot

Request Demo

Home/Resources/Saved

Your Saved Resources

Articles, guides, and glossary terms you saved with the bookmark button.

You haven't saved anything yet. Click the Save button on any article or glossary term to bookmark it here.

A quality management platform designed for regulated life sciences organizations, bringing quality under control.

NAVIGATION

Home Company Solutions Industries Compliance Resources

RESOURCES

Blog Compliance Guides Checklists & Templates Glossary Legal

GET STARTED

Request Demo Contact Start Pilot

© 2026 Complere. All rights reserved.