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.