The HAVGATE platform

Quality is the lead. Business operations sit beside it, in separate modules, so a small regulated company can run audits and also run customers and invoices without mixing the records.

Quality modules

These modules exist in the product and have public pages, except items and bills of materials, which exist in the application as change-controlled records and are reached from the eQMS rather than from a second marketing site. Calibration scheduling is not a shipped module.

Audit management — Available. ISO 13485, ISO 9001, MDSAP and EU MDR audits, with report generation and approval.

CAPA and nonconformance — Available. Nonconformances, 5 Whys, Fishbone, and effectiveness checks linked to the source finding.

Document control — Available. Procedures, revisions, approvals and electronic signatures.

Training — Available. Role-based training assignments and completion records.

Supplier quality — Available. Approved suppliers, risk, re-evaluation and CAPA links.

MDSAP checklist — Available. AU P0002.010 tasks across all seven chapters.

Items and bills of materials — Available. Item and BOM records with change control, inside the eQMS.

Calibration and maintenance — Coming soon. Equipment calibration scheduling is described as a future quality module. It is not a separate product page today.

Business modules

CRM and bookkeeping are implemented in the application and turned on per workspace. They are not medical-device records, and they are not included in the audit-platform prices. Agency projects for websites, portals and custom tools are a different offer and live under services.

CRM

The CRM workspace covers companies, contacts, pipeline and related lead work. It is available in the product. Public visitors are not dropped into that workspace from this page, because access is granted per workspace. Ask for it to be enabled, or sign in if it already is.

Bookkeeping

Bookkeeping in the product includes customers, quotes, invoices, receipts, a ledger, statements and reports. It is available in the product and enabled per workspace. It is separate from CAPA, device records and the audit trail of the QMS.