FAQs

An electronic Quality Management System (eQMS) is a software platform that manages the quality processes required by regulated industries — document control, CAPA, audits, training, change control, and risk management. Any pharmaceutical, biotech, medical device, healthcare, or life sciences organization subject to GMP, FDA, EU, or ISO standards typically needs an eQMS to demonstrate compliance and maintain inspection-ready records.

Complere supports Part 11 requirements for electronic records and electronic signatures. Every governed workflow produces a time-stamped, user-attributed audit trail. Signatures require re-authentication and capture the meaning of the action (e.g., approved, reviewed, rejected). Records are protected from alteration and remain retrievable for inspection.

Complere is configured to meet Annex 11 expectations for computerized systems in GMP environments — including access controls, audit trails, validation evidence, change management after go-live, and data integrity. The platform includes a CSV package to support formal qualification.

Yes. Every Complere deployment includes structured validation documentation: Validation Master Plan (VMP), User Requirements Specification (URS), Configuration Specification (CS), Test Plan, and IQ/OQ/PQ protocols. This reduces the customer's validation effort and accelerates compliant deployment.

Most teams complete a focused 30-day pilot covering one workflow. Full deployment across the core module set typically takes 60 to 90 days depending on site complexity, user groups, and validation requirements. Multi-site standardization is planned on a phased basis.

Complere includes these modules: Document Control, CAPA & Deviations, Audit Management, Training & Competency (LMS), Change Control, Risk Management, Management Review & Dashboards, Compliance Intelligence, and the Pilot Approach framework. All modules share one audit trail, one permission model, and one validation posture.

Yes. Complere supports ISO 13485 quality management and ISO 14971 risk management requirements for medical device manufacturers. Note that Complere does not currently include a dedicated equipment calibration or maintenance module.

Complere uses a multi-tenant architecture where each site or entity operates in a fully isolated environment with separate data, users, and configurations. Cross-site reporting and KPI standardization can be enabled at the enterprise tier.

Complere includes role-based access control (RBAC) with 210+ configurable permissions, two-factor authentication (2FA), single sign-on (SSO) support, tenant-level database isolation, and GDPR-compliant data handling. A security overview is available on request.

A pilot is a 30-day engagement scoped to one workflow, team, or site — typically document control, CAPA, or audit management. A full deployment covers all planned modules, sites, and user groups, and includes formal IQ/OQ/PQ qualification. The pilot is designed to prove fit and lower the risk of full commitment.

Pricing scales by deployment scope, not by user count alone. The Pilot tier is priced for one workflow. The Core tier is scoped to the module set you roll out — for example document control + CAPA + audit. The Enterprise tier scopes by number of sites, modules, and SSO or integration scope. The validation package is included at every tier. Contact sales for a scoped quote — there is no published per-seat list price.

Included in every tier: CSV validation package (VMP, URS, CS, Test Plan, IQ/OQ/PQ templates), implementation planning, user and role configuration support, compliance guide and training library access, and a defined expansion path. Charged separately: extended onboarding workshops, custom integrations, dedicated regional hosting, and migration from non-standard legacy formats.

Standard term is one year, billed annually, with 60-day notice for non-renewal. On termination you retain data export rights for an agreed retention window — typically 90 days. Tenant data is then scheduled for deletion per the Data Processing Agreement. Audit trail records can be exported in human-readable and machine-readable formats before deletion.

Under NDA we share: data flow diagram, sub-processor list, GDPR-aligned Data Processing Agreement, FDA 21 CFR Part 11 controls matrix, latest penetration test summary, security architecture overview, business continuity plan summary, and a completed vendor security questionnaire (CAIQ-aligned). Current SOC 2 attestation status is available on request from your account contact. See also the Security & Privacy page.

Hosting region is set at tenant provisioning. Each tenant runs in an isolated environment with its own database. Data does not move across regions without explicit written customer consent. EU customers receive a data-residency commitment in the DPA. Region availability and data-residency options are confirmed during pilot scoping.

IQ (Installation Qualification) and OQ (Operational Qualification) are executed by Complere using a controlled, pre-approved test pack. PQ (Performance Qualification) is executed jointly: Complere provides scripts and evidence templates, your QA team executes against your business processes and signs the validation summary report. Customer-led PQ with Complere providing templates only is also supported. See the validation approach.

Standard migration uses CSV or Excel import with column mapping for controlled documents, training records, supplier lists, and master data. Migration from legacy eQMS platforms such as MasterControl, Veeva, or ETQ uses scoped extract scripts during Core deployment. Migration is treated as a controlled change, with reconciliation evidence captured in the IQ pack.

Before contract end you receive a full export: documents in PDF with signature pages, structured records (CAPA, audits, training, change) in CSV and JSON, and the audit trail in CSV with hash-chain integrity evidence. Audit trail retention before deletion follows your regulatory obligation — typically 6+ years for Part 11 records. A tenant data deletion certificate is provided when the retention window closes.