01
Access and security controls
Review user and privileged access, account lifecycle, authentication, permission assignments and the records available to demonstrate how controls operate.
MONTRÉAL / TECHNOLOGY AUDIT & IT RISK
A clear view of your technology and its risks.
MDose AI helps Montréal and Québec organizations assess software, infrastructure and technology controls. We define the review criteria with your team, examine evidence and turn findings into a practical remediation roadmap, with pharmaceutical context where it matters.
Serving Montréal and Québec · English & French
Make the next technology decision with evidence.
A modernization, a supplier change or a concern about access and recovery can be a useful starting point for a focused assessment.
Where we can help
Review the systems your operations depend on.
02
Change and software delivery
Examine how requirements, releases, configuration changes, testing, approvals and incidents are managed across the system lifecycle.
03
Operations and resilience
Assess backup and restore arrangements, monitoring, responsibilities, dependencies and continuity documentation within the agreed scope.
04
Governance and regulated use
Connect ownership, supplier oversight and data flows with business risks. For pharmaceutical systems, consider intended use and the implications for records and data integrity.
What you receive
A clear scope. Results you can review.
Scope and control matrix
Objectives, boundaries, review criteria and the controls selected for assessment.
Evidence and test records
A traceable register of reviewed documents, interviews, configuration evidence and test procedures.
Findings and executive report
Observed conditions, supporting criteria, business risk and recommendations, with agreed severity definitions.
Remediation roadmap
Prioritized actions, proposed ownership and a basis for follow-up verification.
Our experience in software development and pharmaceutical technology is supported by completed ISPE training:
- T45 — GAMP 5 Basic Principles
- T50 — Data Integrity and 21 CFR Part 11
- G01 — GMP Fundamentals for the Pharmaceutical Industry
Course links lead to the official ISPE descriptions.
FAQ
Questions before we start
What is the difference between an audit and a technical review?
An audit requires defined objectives and criteria, sufficient evidence, documented testing and a supported conclusion. A technical review can be narrower or advisory. The engagement letter establishes which service is being provided.
Can the assessment cover Microsoft 365 and SharePoint?
Yes. Depending on scope, it can cover identities, permissions, configuration, workflows, records, integrations and the procedures governing their use.
Is this a penetration test or an accredited certification audit?
This service is a technology and control assessment. Penetration testing and accredited certification audits require their own scope and appropriate specialist arrangements.
What if MDose also builds or maintains the system?
We identify prior implementation or operational responsibilities when scoping the work. Where independent assurance is required, the review must address self-review risks and may require a separate qualified reviewer.
MONTRÉAL
Explore our Montréal services
01
Technology expertise for teams in Montréal.
MDose AI supports Montréal and Québec teams with technology audits, GxP software validation, AI automation and custom software. Services in French and English.
Technology expertise for teams in Montréal.02
Software validation built around intended use.
Risk-based computerized system validation for Montréal pharmaceutical teams: intended use, URS, testing, traceability, data integrity and SharePoint validation.
Software validation built around intended use.03
Build software around the way your team works.
Custom software and AI automation for Montréal and Québec teams. Business applications, integrations and practical project support.
Build software around the way your team works.MDOSE AI / Technology Audit & IT Risk Assessment in Montréal
Let’s define the right next step.
Tell us about your systems, your team and the decision you need to make. We will agree on a practical scope, responsibilities and deliverables.