Regulatory and validation

# Validation projects, protocols and reports
Plan, execute and document equipment, facility and utility, process, cleaning and computer system validation: an AI-drafted plan with pre-execution activities, owners and due dates; protocols and reports from Part 11-ready templates; results, deviations, approvals and closure.
In the portal: [/app/validation](https://qlogix.ai/app/validation)

## The validation life cycle
Validation project - Person
1. Create the project
Type, system, risk, target date

- AI drafts
2. Draft the plan and activities
10 to 30 activities with owners and dates

- Person
3. Assign owners and dates

- E-signature
4. Validation plan approval

- E-signature
5. Protocols approved
IQ, OQ, PQ, PPQ or CVP before execution

- Person
6. Execute and report
Results, deviations, qualification reports

- E-signature
7. Summary report signed
VSR

- E-signature
8. Validation closure
Validated, with conditions, or not

- A report can only be created from an approved protocol: "The protocol must be approved before execution and reporting."

## Create a project
- 1Step 1 : Open [Validation](https://qlogix.ai/app/validation) and choose New validation project.
- 2Step 2 : Choose the Validation type: Equipment, Facility and utilities, Process, Cleaning, or Computer systems (CSV, with a GAMP 5 category 1, 3, 4 or 5).
- 3Step 3 : Enter the Project title and System name (required), the asset ID, site, area, department, validation owner, risk level (High, Medium, Low), target date, change control reference and a system description.
- 4Step 4 : Attach user requirements, supplier documentation, drawings or P&IDs, risk assessments, existing protocols, SOPs or change controls.
- 5Step 5 : Keep Draft the plan and activities now (AI) ticked and choose Create and draft the plan.

## Plan and activities
The plan covers the approach, scope, deliverables, acceptance criteria, prerequisites before execution, risks, regulatory basis and questions for the validation lead. The AI proposes activities in five phases (Planning, Pre-execution, Execution, Reporting, Closure), each with an owner role and a due date in working days.
- Assign a person to each activity (they are emailed) and Set due date; reassigning or rescheduling needs a reason.
- Statuses: Open, In progress, Blocked (reason), Done (evidence required: Record and mark done) and Cancelled (reason). Activities are never deleted.
- Add an activity for anything the plan missed. View the planner as a list or timeline, filtered by All, Mine, Overdue or Open.
- [Activities](https://qlogix.ai/app/validation/activities) tracks every open activity across projects by due week, with filters for mine, overdue, due in 14 days, unassigned and blocked.
- Draft the plan again (with a reason) replaces the plan and the open, unassigned AI activities; activities you added, assigned or started stay.
Before Validation plan approval: the approach written, deliverables chosen, at least one activity, and every open activity with an owner and a due date.

## Protocols, reports and deviations
Document Types
VP, URS, RA, TM Validation plan, user requirements, risk assessment, traceability matrix: all types
DQ, IQ, OQ, PQ protocols Equipment, Facility and utilities, Computer systems
PPQ protocol Process
CVP protocol Cleaning
QR, VSR, DEV Qualification report, validation summary report, protocol deviation report: all types

- 1Step 1 : On the project choose Create from template for a planned deliverable (or use the [Template library](https://qlogix.ai/app/validation/templates)).
- 2Step 2 : Generate with AI fills every section; facts it cannot find are left as [placeholders]. For protocols it drafts 4 to 20 test cases with steps, expected results and acceptance criteria.
- 3Step 3 : Route the protocol for Approval before execution. Execute on the exported copy (actual result, pass or fail, executed by, verified by).
- 4Step 4 : For an approved protocol choose Create the qualification report: the test cases carry over. Record each result Pass, Fail (with a note) or Not executed.
- 5Step 5 : Add a deviation for anything that did not go to plan; close it with its resolution.
- 6Step 6 : Route the report for approval after execution.
Before approval: a document number and no empty sections; protocols need tests with steps, expected results and acceptance criteria; reports need every result recorded and no open deviations.

## Closure
Record the outcome (Validated, Validated with conditions with the conditions stated, or Not validated), write the closure summary, and route Validation closure. Every activity must be done or cancelled, no document in review, and the validation summary report signed unless the outcome is Not validated.
Rule: "Not validated" means the system may not be used for GMP purposes: link the investigation or CAPA.

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Source: https://qlogix.ai/docs/validation
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