Validation-Ready by Design, You Validate for Your Use
Like any eQMS, MoniDoseQMS is validated by you, for your intended use. We support that with a GAMP 5-aligned approach and a Customer Validation Guide with IQ/OQ/PQ protocol templates (draft, shared under NDA).
GAMP 5 Aligned Approach
Our validation methodology follows ISPE GAMP 5 principles, ensuring a structured, risk-based, and scalable approach to computer system validation.
Risk-Based Approach
Validation effort is scaled to the risk each component poses to patient safety, product quality, and data integrity. Higher-risk areas receive deeper testing, while lower-risk elements follow streamlined protocols.
GAMP 5 Category 4 Classification
MoniDoseQMS is typically treated as a configured product (Category 4) under GAMP 5. The category is your call as the regulated user; our supplier documentation (the Customer Validation Guide, currently a pre-release draft) is there to reduce your own validation effort.
V-Model Structure
Our validation templates follow the V-model: user requirements map to performance qualification, functional specifications to operational qualification, and configuration to installation qualification.
Customer Validation Guide
Customers receive our Customer Validation Guide under NDA: IQ/OQ/PQ protocol templates, traceability guidance and execution notes. It is currently a draft, pre-release edition. You adapt it to your intended use and execute it; we answer questions along the way.
Three-Phase Qualification
What the IQ/OQ/PQ protocol templates cover. They are templates: nothing has been executed on your behalf, and you adapt them to your intended use.
Installation Qualification
The IQ template verifies that your MoniDose-hosted workspace is provisioned and configured as specified. Nothing is installed on your side; the protocol covers what you configure.
- Workspace and company settings as specified
- User roles and access configured
- Authentication and two-factor settings
- File storage and e-mail configured
- Backup and recovery arrangements reviewed
Operational Qualification
The OQ templates cover the functions you intend to use: functional requirements, security controls, audit trail behaviour, and electronic signature workflows, including boundary conditions.
- Functional requirements for your use
- Security and access controls
- Audit trail completeness
- Electronic signature workflows
- Error handling and boundary conditions
Performance Qualification
The PQ templates cover your own business processes end to end, run by your users in your workspace, including user acceptance testing.
- End-to-end business processes
- Your user acceptance testing
- Role and approval scenarios
- Records, exports and retrieval
- Your own acceptance criteria
ALCOA+ Data Integrity
MoniDoseQMS is designed to support ALCOA+ data-integrity principles. Your procedures and validation show that they hold in your use.
Attributable
Every record is traceable to the person who created or modified it.
Legible
Records are readable, permanent, and retrievable throughout their retention period.
Contemporaneous
Data is recorded at the time the activity occurs, not after the fact.
Original
The first capture of information is preserved. True copies maintain full integrity.
Accurate
Records reflect what actually happened without editing, deletion, or overwriting.
Complete
No data is missing — all relevant information is captured and retained.
Consistent
Data follows the same format and logic across the entire lifecycle.
Enduring
Records are durable and available for the full required retention period.
Available
Data is accessible when needed for review, audit, or regulatory inspection.
Regulatory Frameworks
Where MoniDoseQMS stands against frameworks for computerised systems. These are self-assessments, not reviewed by a notified body or auditor.
FDA 21 CFR Part 11
Supported, with open itemsSupported, with open items we track openly. E-signatures capture signer, meaning, reason, UTC time, IP address and file hash, with password re-authentication; the audit trail captures who, what, when, IP and before/after values. Open items: failed signature attempts are not yet audit-logged; the Make Effective step is not yet in the web interface.
GAMP 5 (ISPE 2nd Edition)
Aligned approachOur validation templates follow a GAMP 5-aligned, risk-based approach. This is a self-assessed alignment; it is not reviewed or certified by a third party.
ISO 13485:2016
SupportedThe platform provides functions and SOP templates that support organisations running an ISO 13485 quality management system. It is software, not a certification of your QMS.
ISO 14971
SupportedRisk records following ISO 14971 (severity x probability, with detectability where set) that you can link to your validation risk assessment.
21 CFR Part 11 Controls
How MoniDoseQMS addresses each Part 11 area, and where open items remain.
System Validation
IQ/OQ/PQ protocol templates and traceability guidance in the Customer Validation Guide (draft, under NDA). You execute them for your intended use.
Electronic Signatures
The signer re-enters their password. Each signature captures signer identity, meaning, reason, UTC date/time, IP address and the SHA-256 hash of the signed file. Signed records lock against editing; changes need a new revision.
Audit Trails
A tamper-evident, SHA-256 hash-chained audit trail records who, what, when, IP address, and before and after values for every create, update and delete.
Copies of Records
Export records to CSV (Excel or PDF on selected reports). Stored files carry a SHA-256 hash.
Shared Responsibility Model
Validation is a shared effort. We provide the platform, documentation, and support — you own the execution and maintenance of the validated state in your environment.
MoniDose Provides
- Maintain a documented Software Development Lifecycle (SDLC)
- Provide the Customer Validation Guide and protocol templates (draft, under NDA)
- Run an automated test suite and guardrail checks on every build
- Operate the hosted platform, backups and updates
- Answer your questions while you validate
You Own
- Develop validation protocols using our templates and guidance
- Execute and document IQ/OQ/PQ test cases in your environment
- Perform risk-based testing appropriate to your regulatory context
- Assess change impact when applying platform updates
- Conduct periodic reviews to maintain validated state
- Document deviations and corrective actions
Continuous Validation Readiness
Validation is not a one-time event. The platform is updated by us, so you assess the impact of changes on your intended use. The Customer Validation Guide includes periodic-review and revalidation guidance to help you keep your own validated state.
Want to see the validation guide?
Request a copy of our Customer Validation Guide (draft, pre-release edition), shared under NDA. No commitment required. Or book a 30-minute validation walkthrough with our team.