01
SharePoint and Microsoft 365
Define controlled-document, workflow and record uses, then assess permissions, versioning, approval steps, retention and interfaces relevant to the validated process.
MONTRÉAL / GxP & COMPUTERIZED SYSTEM VALIDATION
Software validation built around intended use.
MDose AI supports computerized system validation (CSV) for pharmaceutical and regulated teams in Montréal and Québec. We work with your quality and technical teams to connect the business process, system risks, requirements, tests and evidence in a reviewable validation package.
Serving Montréal and Québec · English & French
Scale the evidence to the system and its risks.
The validation boundary depends on the regulated process, records, configuration, integrations, supplier evidence and your quality procedures.
Where we can help
Support for new systems and changes to existing ones.
02
Pharmaceutical applications
Define the intended use of pharmaceutical and business applications, identify critical functions and specify the evidence needed to demonstrate that requirements are met.
03
Data integrity and records
Examine record creation, modification, review, access and retention. Identify where traceability, auditability or electronic signatures need defined controls.
04
Changes and periodic review
Assess the impact of configuration changes, releases and migrations. Document what needs retesting and how the validated state will be maintained.
What you receive
A clear scope. Results you can review.
Validation plan and URS
A defined scope, responsibilities, user requirements and acceptance criteria.
Risk assessment and test strategy
Risks connected to controls and appropriate verification, including IQ/OQ/PQ where suitable.
Tests, evidence and traceability
Executed records, deviations and a matrix linking requirements to verification and results.
Summary and lifecycle controls
A report for quality review, open items and proportionate change and review procedures.
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
Does every application need GxP validation?
The answer depends on intended use, its role in regulated processes or records, applicable requirements and a documented impact assessment. Scoping comes before selecting a validation package.
Do you validate SharePoint?
Yes. We support risk-based validation of the configured SharePoint processes used by a regulated team. Our dedicated SharePoint page explains the scope and deliverables.
What GAMP and GMP training have you completed?
Our completed ISPE courses include T45 GAMP 5 Basic Principles, T50 Data Integrity and 21 CFR Part 11, and G01 GMP Fundamentals for the Pharmaceutical Industry. These are training completions.
Who approves the validated state?
The regulated organization approves the intended use, procedures, acceptance decisions and validation conclusion through its quality system. MDose supplies the agreed assessment, testing and documentation support.
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
A clear view of your technology and its risks.
Technology audits and IT control assessments for Montréal and Québec teams. Review systems, access, changes, backups and governance with prioritized findings.
A clear view of your technology and its risks.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 / GxP Software Validation & CSV 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.