Question 1

What is QMSdesk and who is it built for?

Accepted Answer

QMSdesk is a next-generation electronic Quality Management System (eQMS) engineered specifically by GxP quality practitioners for Pharmaceutical, Medical Device (ISO 13485 / EU MDR), Biotechnology, and CRO/CDMO organizations. It replaces fragmented paper and SharePoint systems with 8 connected quality modules, cryptographic SHA-256 audit trails, and predictable tiered pricing.

Question 2

How does QMSdesk comply with FDA 21 CFR Part 11 and EU Annex 11?

Accepted Answer

QMSdesk enforces dual-factor authentication, cryptographic timestamping, automated Segregation of Duties (SoD), and immutable SHA-256 chained audit logs anchored at the database level. Every record creation, review, and approval generates a legally binding, audit-ready electronic signature record.

Question 3

How is QMSdesk validated, and how long does implementation take?

Accepted Answer

QMSdesk deploys rapidly with a vendor-validated SaaS baseline (Platform URS, FMEA Risk Assessment, RTM, and Core Functional OQ evidence), allowing customers to streamline intended-use verification (PQ/UAT) using pre-configured Industry Packs and lean CSA templates.

Question 4

How does QMSdesk pricing compare to legacy eQMS software?

Accepted Answer

Unlike legacy platforms (Veeva, MasterControl) that charge $800–$1,500+ per user per year plus expensive add-on modules, QMSdesk provides predictable organization-tiered subscriptions (1–25, 26–250, 251+ users) with all 8 core quality modules included standard, resulting in approximately 50%–70% lower 5-year Total Cost of Ownership (TCO).

QMSdesk Terms of Service

1. SaaS Subscription & Tiered Organization Licensing

2. Service Level Agreement (SLA) & Uptime Guarantee

3. Computerized System Validation (CSV & CSA)

4. Contact Legal & Compliance