https://complere.tech/about/ https://complere.tech/assets/images/company/company-office-workspace.jpg Complere team working in modern open-plan office Complere team working in modern open-plan office https://complere.tech/assets/images/company/company-team-whiteboard.jpg Complere team collaborating at whiteboard Complere team collaborating at whiteboard https://complere.tech/assets/images/company/company-engineers-pairing.jpg Complere engineers pair programming Complere engineers pair programming https://complere.tech/careers/ https://complere.tech/assets/images/company/company-office-workspace.jpg Complere office workspace with diverse team Complere office workspace with diverse team https://complere.tech/assets/images/company/company-engineers-pairing.jpg Two software engineers pair programming Two software engineers pair programming https://complere.tech/assets/images/company/company-culture-coffee-break.jpg Team members at coffee break in office Team members at coffee break in office https://complere.tech/compliance/ https://complere.tech/assets/images/company/regulatory-affairs-compliance-desk.jpg Compliance Hub Compliance Hub https://complere.tech/assets/images/diagrams/regulations-supported-grid.svg Regulations Complere supports: 21 CFR Part 11, EU Annex 11, ISO 9001, ISO 13485, ISO 14971, ICH Q9, GAMP 5, 21 CFR 111, 21 CFR 820 Regulations Complere supports: 21 CFR Part 11, EU Annex 11, ISO 9001, ISO 13485, ISO 14971, ICH Q9, GAMP 5, 21 CFR 111, 21 CFR 820 https://complere.tech/contact/ https://complere.tech/assets/images/diagrams/contact-channels.svg Contact Complere: email, schedule demo, live chat, support portal Contact Complere: email, schedule demo, live chat, support portal https://complere.tech/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Complere Quality Overview dashboard showing records, actions, and connected quality status. Complere Quality Overview dashboard showing records, actions, and connected quality status. https://complere.tech/assets/images/product/screenshot-document-control-hero.png Document Control Document Control https://complere.tech/assets/images/product/screenshot-capa-investigation-detail.png CAPA & Deviations CAPA & Deviations https://complere.tech/assets/images/product/screenshot-audit-management-hero.png Audit Management Audit Management https://complere.tech/assets/images/product/screenshot-training-matrix.png Training & Competency Training & Competency https://complere.tech/assets/images/product/screenshot-change-control-hero.png Change Control Change Control https://complere.tech/assets/images/product/screenshot-risk-matrix-tab.png Risk Assessments Risk Assessments https://complere.tech/assets/images/resources/paper-qms-pain.jpg Moving from paper QMS Moving from paper QMS https://complere.tech/assets/images/resources/excel-deviation-tracking-pain.jpg Replacing spreadsheet tracking Replacing spreadsheet tracking https://complere.tech/assets/images/resources/legacy-eqms-frustration.jpg Legacy eQMS replacement Legacy eQMS replacement https://complere.tech/assets/images/industry/cmo-cdmo-multi-client-shop-floor.jpg Multi-site scale Multi-site scale https://complere.tech/assets/images/resources/resource-compliance-reading.jpeg Blog Blog https://complere.tech/assets/images/resources/deviation-checklist-flatlay.jpg Checklists & Templates Checklists & Templates https://complere.tech/industries/ https://complere.tech/assets/images/industry/pharma-fill-finish-cleanroom.jpg Pharmaceutical fill-finish cleanroom operation Pharmaceutical fill-finish cleanroom operation https://complere.tech/assets/images/industry/medical-device-assembly-cleanroom.jpg Medical device assembly cleanroom Medical device assembly cleanroom https://complere.tech/assets/images/industry/clinical-diagnostic-laboratory.jpg Clinical diagnostic laboratory Clinical diagnostic laboratory https://complere.tech/assets/images/industry/nutraceutical-capsule-filling-line.jpg Nutraceutical capsule filling production line Nutraceutical capsule filling production line https://complere.tech/assets/images/industry/cmo-cdmo-multi-client-shop-floor.jpg CMO CDMO multi-client manufacturing shop floor CMO CDMO multi-client manufacturing shop floor https://complere.tech/assets/images/industry/cro-clinical-data-management-office.jpg Clinical research organization data management office Clinical research organization data management office https://complere.tech/legal/ https://complere.tech/assets/images/company/legal-agreement-trust.jpg Legal Legal https://complere.tech/platform/ https://complere.tech/assets/images/diagrams/platform-at-a-glance.svg Complere eQMS platform — 8 modules plus shared services Complere eQMS platform — 8 modules plus shared services https://complere.tech/pricing/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Pricing Pricing https://complere.tech/request-demo/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Request Demo Request Demo https://complere.tech/resources/ https://complere.tech/assets/images/diagrams/resources-hub.svg Complere resource library: blog, guides, templates, glossary Complere resource library: blog, guides, templates, glossary https://complere.tech/assets/images/resources/resource-compliance-reading.jpeg Blog Blog https://complere.tech/assets/images/resources/regulation-binders-shelf.jpg Compliance Guides Compliance Guides https://complere.tech/assets/images/resources/deviation-checklist-flatlay.jpg Checklists & Templates Checklists & Templates https://complere.tech/assets/images/resources/faqs-help-desk-flatlay.jpg FAQs FAQs https://complere.tech/assets/images/resources/gmp-regulatory-glossary-reference.jpg Glossary Glossary https://complere.tech/solutions/ https://complere.tech/assets/images/diagrams/solutions-outcomes-quadrant.svg Quality outcomes: audit readiness, traceability, accountability, visibility Quality outcomes: audit readiness, traceability, accountability, visibility https://complere.tech/start-pilot/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Start Pilot Start Pilot https://complere.tech/compliance/data-integrity-audit-trails/ https://complere.tech/assets/images/product/screenshot-audit-trail-log.png Data Integrity & Audit Trails Data Integrity & Audit Trails https://complere.tech/assets/images/diagrams/alcoa-plus-complere-controls.svg ALCOA+ data integrity principles mapped to Complere controls ALCOA+ data integrity principles mapped to Complere controls https://complere.tech/compliance/electronic-records-signatures/ https://complere.tech/assets/images/product/screenshot-esignature-workflow.png Electronic Records & Signatures Electronic Records & Signatures https://complere.tech/assets/images/diagrams/part-11-control-coverage.svg 21 CFR Part 11 control coverage in Complere eQMS 21 CFR Part 11 control coverage in Complere eQMS https://complere.tech/compliance/security-privacy/ https://complere.tech/assets/images/company/security-access-control-admin.jpg Security & Privacy Security & Privacy https://complere.tech/assets/images/diagrams/security-privacy-architecture.svg Complere security and privacy architecture: 5 layers from identity to compliance Complere security and privacy architecture: 5 layers from identity to compliance https://complere.tech/compliance/validation-approach/ https://complere.tech/assets/images/company/validation-specialist-protocol-review.jpg Validation Approach Validation Approach https://complere.tech/assets/images/diagrams/csa-v-model-complere.svg CSA V-Model applied to Complere: URS → FRS → CS → Build → OQ → UAT → PQ CSA V-Model applied to Complere: URS → FRS → CS → Build → OQ → UAT → PQ https://complere.tech/industries/clinical-research-cros/ https://complere.tech/assets/images/industry/cro-clinical-data-management-office.jpg Clinical research associates at data management workstations with study timeline whiteboard Clinical research associates at data management workstations with study timeline whiteboard https://complere.tech/assets/images/resources/resource-training-competency.jpeg Training & competency Training & competency https://complere.tech/assets/images/product/screenshot-audit-trail-log.png Data integrity guide Data integrity guide https://complere.tech/assets/images/product/screenshot-change-control-approval.png Process accountability solution Process accountability solution https://complere.tech/industries/cmo-cdmo/ https://complere.tech/assets/images/industry/cmo-cdmo-multi-client-shop-floor.jpg Contract manufacturing GMP shop floor with blister packaging line and multi-client operations Contract manufacturing GMP shop floor with blister packaging line and multi-client operations https://complere.tech/assets/images/product/screenshot-audit-findings.png Audit readiness solution Audit readiness solution https://complere.tech/assets/images/company/security-access-control-admin.jpg Security & privacy Security & privacy https://complere.tech/industries/healthcare-laboratories/ https://complere.tech/assets/images/industry/clinical-diagnostic-laboratory.jpg Clinical laboratory technicians operating diagnostic analyzer with sample tubes Clinical laboratory technicians operating diagnostic analyzer with sample tubes https://complere.tech/assets/images/product/screenshot-training-matrix.png Training management blog Training management blog https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Quality visibility solution Quality visibility solution https://complere.tech/assets/images/product/screenshot-training-list-tab.png Training matrix template Training matrix template https://complere.tech/industries/medical-devices/ https://complere.tech/assets/images/industry/medical-device-assembly-cleanroom.jpg Medical device assembly technicians at ESD workbench in cleanroom Medical device assembly technicians at ESD workbench in cleanroom https://complere.tech/assets/images/resources/resource-compliance-reading.jpeg Validation approach Validation approach https://complere.tech/assets/images/product/screenshot-change-control-approval.png Process accountability Process accountability https://complere.tech/assets/images/resources/resource-audit-trail-data-integrity.jpeg Audit trail glossary term Audit trail glossary term https://complere.tech/industries/nutraceuticals-supplements/ https://complere.tech/assets/images/industry/nutraceutical-capsule-filling-line.jpg Nutraceutical capsule filling line operators in cGMP production facility Nutraceutical capsule filling line operators in cGMP production facility https://complere.tech/assets/images/resources/resource-excel-workflows.jpeg Excel to controlled workflows Excel to controlled workflows https://complere.tech/assets/images/product/screenshot-change-control-approval.png Change impact assessment template Change impact assessment template https://complere.tech/assets/images/product/screenshot-audit-trail-log.png Data integrity page Data integrity page https://complere.tech/industries/pharmaceutical-manufacturing/ https://complere.tech/assets/images/industry/pharma-fill-finish-cleanroom.jpg Pharmaceutical fill-finish cleanroom operators monitoring vial filling line Pharmaceutical fill-finish cleanroom operators monitoring vial filling line https://complere.tech/assets/images/resources/regulation-binder-desk.jpg FDA Part 11 playbook FDA Part 11 playbook https://complere.tech/assets/images/resources/regulation-binders-shelf.jpg Annex 11 validation guide Annex 11 validation guide https://complere.tech/assets/images/resources/resource-deviation-capa.jpeg Deviation investigation checklist Deviation investigation checklist https://complere.tech/platform/audit-confidence/ https://complere.tech/assets/images/diagrams/audit-ready-4-steps.svg Audit-ready in 4 steps: collect evidence, link to requirement, generate audit pack, review with auditor Audit-ready in 4 steps: collect evidence, link to requirement, generate audit pack, review with auditor https://complere.tech/platform/audit-management/ https://complere.tech/assets/images/product/screenshot-audit-management-hero.png Audit Management Audit Management https://complere.tech/assets/images/product/screenshot-audit-findings.png Audit Management Audit Management https://complere.tech/platform/capa-deviations/ https://complere.tech/assets/images/product/screenshot-capa-investigation-detail.png CAPA & Deviations CAPA & Deviations https://complere.tech/assets/images/product/screenshot-capa-list-tab.png CAPA & Deviations CAPA & Deviations https://complere.tech/platform/change-control/ https://complere.tech/assets/images/product/screenshot-change-control-hero.png Change Control Change Control https://complere.tech/assets/images/product/screenshot-change-control-approval.png Change Control Change Control https://complere.tech/platform/compliance-intelligence/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Compliance Intelligence Compliance Intelligence https://complere.tech/assets/images/product/screenshot-audit-trail-log.png Compliance Intelligence Compliance Intelligence https://complere.tech/platform/dashboards-kpis/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Dashboards & KPIs Dashboards & KPIs https://complere.tech/assets/images/product/screenshot-event-management-list.png Dashboards & KPIs Dashboards & KPIs https://complere.tech/platform/document-control/ https://complere.tech/assets/images/product/screenshot-document-control-hero.png Document Control Document Control https://complere.tech/platform/management-review/ https://complere.tech/assets/images/product/management-review-executive-session.jpg Management Review Management Review https://complere.tech/platform/modules/ https://complere.tech/assets/images/diagrams/platform-at-a-glance.svg Complere eQMS — all 8 quality modules Complere eQMS — all 8 quality modules https://complere.tech/platform/pilot-approach/ https://complere.tech/assets/images/diagrams/pilot-8-week-timeline.svg Typical 8-week Complere pilot timeline Typical 8-week Complere pilot timeline https://complere.tech/platform/risk-assessments/ https://complere.tech/assets/images/product/screenshot-risk-matrix-tab.png Risk Assessments Risk Assessments https://complere.tech/assets/images/product/screenshot-risk-register.png Risk Assessments Risk Assessments https://complere.tech/platform/training-competency/ https://complere.tech/assets/images/product/screenshot-training-matrix.png Training & Competency Training & Competency https://complere.tech/assets/images/product/screenshot-training-list-tab.png Training & Competency Training & Competency https://complere.tech/resources/blog/ https://complere.tech/assets/images/resources/regulation-binder-desk.jpg Regulation binder open on desk — FDA 21 CFR Part 11 compliance guide Regulation binder open on desk — FDA 21 CFR Part 11 compliance guide https://complere.tech/assets/images/blog/qmsr-vs-iso-13485-what-actually-changes-for-quality-systems.png QMSR vs ISO 13485: What Actually Changes for Quality Systems QMSR vs ISO 13485: What Actually Changes for Quality Systems https://complere.tech/assets/images/blog/connected-quality-records-in-pharma-why-silos-still-fail-under-inspection.png Connected Quality Records in Pharma: Why Silos Still Fail Under Inspection Connected Quality Records in Pharma: Why Silos Still Fail Under Inspection https://complere.tech/assets/images/blog/csa-vs-csv-in-pharma-what-software-assurance-actually-means-under-inspection.png CSA vs CSV in Pharma: What Software Assurance Actually Means Under Inspection CSA vs CSV in Pharma: What Software Assurance Actually Means Under Inspection https://complere.tech/assets/images/blog/document-control-in-pharma-why-version-history-still-fails.png Document Control in Pharma: Why Version History Still Fails Document Control in Pharma: Why Version History Still Fails https://complere.tech/assets/images/blog/the-real-cost-of-free-quality-tools-in-pharma-what-breaks-under-inspection.png The Real Cost of "Free" Quality Tools in Pharma: What Breaks Under Inspection The Real Cost of "Free" Quality Tools in Pharma: What Breaks Under Inspection https://complere.tech/assets/images/blog/what-pharma-cdmos-should-demand-from-an-eqms.png What Pharma CDMOs Should Demand From an eQMS What Pharma CDMOs Should Demand From an eQMS https://complere.tech/assets/images/blog/alcoa-plus-in-practice-what-makes-a-record-trustworthy.png ALCOA+ in Practice: What Makes a Record Trustworthy ALCOA+ in Practice: What Makes a Record Trustworthy https://complere.tech/assets/images/blog/deviation-capa-and-change-control-in-pharma-why-they-must-stay-linked.png Deviation, CAPA, and Change Control in Pharma: Why They Must Stay Linked Deviation, CAPA, and Change Control in Pharma: Why They Must Stay Linked https://complere.tech/assets/images/blog/eqms-for-pharma-manufacturing-how-to-evaluate-before-you-buy.png eQMS for Pharma Manufacturing: How to Evaluate Before You Buy eQMS for Pharma Manufacturing: How to Evaluate Before You Buy https://complere.tech/assets/images/blog/qms-vs-eqms-in-pharma-what-actually-changes.png QMS vs eQMS in Pharma: What Actually Changes QMS vs eQMS in Pharma: What Actually Changes https://complere.tech/assets/images/blog/training-effectiveness-in-pharma-why-completion-is-not-enough.png Training Effectiveness in Pharma: Why Completion Is Not Enough Training Effectiveness in Pharma: Why Completion Is Not Enough https://complere.tech/assets/images/blog/why-audit-trails-fail-even-in-digital-systems.png Why Audit Trails Fail Even in Digital Systems Why Audit Trails Fail Even in Digital Systems https://complere.tech/assets/images/blog/why-hybrid-paper-digital-quality-systems-fail-inspections.png Why Hybrid Paper-Digital Quality Systems Fail Inspections Why Hybrid Paper-Digital Quality Systems Fail Inspections https://complere.tech/assets/images/blog/21-cfr-part-11-what-pharma-teams-actually-need-to-know.png 21 CFR Part 11: What Pharma Teams Actually Need to Know 21 CFR Part 11: What Pharma Teams Actually Need to Know https://complere.tech/assets/images/blog/why-spreadsheets-fail-in-regulated-quality-systems.png Why Spreadsheets Fail in Regulated Quality Systems Why Spreadsheets Fail in Regulated Quality Systems https://complere.tech/resources/faqs/ https://complere.tech/assets/images/diagrams/faqs-hero.svg Frequently asked questions about Complere, validation, and deployment Frequently asked questions about Complere, validation, and deployment https://complere.tech/resources/glossary/ https://complere.tech/assets/images/diagrams/glossary-hub.svg A-Z quality glossary with featured term definitions A-Z quality glossary with featured term definitions https://complere.tech/resources/guides/ https://complere.tech/assets/images/resources/regulation-binders-shelf.jpg Annex 11 validation playbook for life-sciences quality teams Annex 11 validation playbook for life-sciences quality teams https://complere.tech/resources/templates/ https://complere.tech/assets/images/resources/deviation-checklist-flatlay.jpg Deviation Investigation Worksheet checklist flat-lay on desk Deviation Investigation Worksheet checklist flat-lay on desk https://complere.tech/solutions/audit-readiness/ https://complere.tech/assets/images/product/screenshot-audit-findings.png Audit Readiness Audit Readiness https://complere.tech/solutions/end-to-end-traceability/ https://complere.tech/assets/images/diagrams/end-to-end-traceability-chain.svg End-to-end record traceability chain: SOP → Training → Deviation → CAPA → Change Request → Audit Finding End-to-end record traceability chain: SOP → Training → Deviation → CAPA → Change Request → Audit Finding https://complere.tech/solutions/excel-to-controlled-workflows/ https://complere.tech/assets/images/resources/excel-deviation-tracking-pain.jpg Excel to Controlled Workflows Excel to Controlled Workflows https://complere.tech/solutions/legacy-eqms-replacement/ https://complere.tech/assets/images/resources/legacy-eqms-frustration.jpg Modern cloud SaaS eQMS platform replacing legacy system Modern cloud SaaS eQMS platform replacing legacy system https://complere.tech/solutions/multi-site-standardization/ https://complere.tech/assets/images/resources/multi-site-quality-coordination.jpg Global multi-site team meeting for quality standardization Global multi-site team meeting for quality standardization https://complere.tech/solutions/paper-based-to-digital-qms/ https://complere.tech/assets/images/resources/paper-to-digital.jpg Hands transitioning from paper forms to digital tablet QMS Hands transitioning from paper forms to digital tablet QMS https://complere.tech/solutions/process-accountability/ https://complere.tech/assets/images/product/screenshot-change-control-approval.png Process Accountability Process Accountability https://complere.tech/solutions/quality-visibility/ https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Quality Visibility Quality Visibility https://complere.tech/resources/glossary/audit-trail/ https://complere.tech/assets/images/diagrams/audit-trail-anatomy.svg Anatomy of an audit trail entry: who, when, what changed, why, where Anatomy of an audit trail entry: who, when, what changed, why, where https://complere.tech/assets/images/resources/resource-audit-trail-data-integrity.jpeg Data Integrity & Audit Trails Data Integrity & Audit Trails https://complere.tech/assets/images/product/screenshot-esignature-workflow.png Electronic Records & Signatures Electronic Records & Signatures https://complere.tech/assets/images/product/screenshot-audit-management-hero.png Audit Readiness Audit Readiness https://complere.tech/resources/guides/annex-11-validation-playbook/ https://complere.tech/assets/images/resources/regulation-binders-shelf.jpg Regulation binders on shelf — EU Annex 11 validation playbook Regulation binders on shelf — EU Annex 11 validation playbook https://complere.tech/assets/images/diagrams/csa-v-model-complere.svg CSA V-Model applied to Complere eQMS validation CSA V-Model applied to Complere eQMS validation https://complere.tech/assets/images/resources/eqms-pilot-kickoff-meeting.jpg Pilot Approach Pilot Approach https://complere.tech/assets/images/product/screenshot-platform-dashboard-hero.png Pricing Pricing https://complere.tech/resources/templates/deviation-investigation-checklist/ https://complere.tech/assets/images/resources/deviation-checklist-flatlay.jpg Deviation Investigation Worksheet checklist on desk Deviation Investigation Worksheet checklist on desk https://complere.tech/assets/images/resources/resource-deviation-capa.jpeg CAPA & Deviations CAPA & Deviations https://complere.tech/assets/images/product/screenshot-change-control-approval.png Process Accountability Process Accountability https://complere.tech/assets/images/resources/resource-compliance-reading.jpeg Blog Blog