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Prototype · plans, experiments and reports contain example content. Methods and theme are stored only in this browser. Use Settings → Browser data to download a backup before changing devices or site addresses.

METHOD LIFECYCLE

Method & Validation Manager

Plan, execute, and track analytical method validation across your product lifecycle.

Active Methods

In Validation

Pending Review

Completed This Quarter

Validation Pipeline

All Product Areas

Method Development
18

Qualification
12

Validation
8

Pending Review
6

Approved
14

Featured Method

View Method →

ELISA Potency Assay

MTH-0042 · Protein Therapeutic

In Validation

Overall Progress76%

✓

Method DevelopmentCompleted

Mar 12

✓

QualificationCompleted

Apr 3

Validation3 of 5 experiments complete

76%

Pending ReviewNot started

Recent Methods

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Upcoming Review Milestones

HPLC Purity AnalysisRegulatory Review

Apr 15

ELISA Potency AssayValidation Report

Apr 18

CE-SDS PurityData Package Review

Apr 22

Open Actions

Complete precision studyELISA Potency Assay

High

Review outlier resultsHPLC Purity Analysis

Medium

Prepare validation reportEndotoxin (LAL)

Low

CONTROLLED METHODS

Methods

Create and manage analytical methods across development, qualification, validation and routine use.

VALIDATION CONTROL

Validation Plans

Define scope, parameters, acceptance criteria, reviewers and evidence requirements.

Draft

Approved

In Execution

Closed

Plan	Method	Parameters	Status
VP-0017	ELISA Potency Assay	Accuracy, Precision, Specificity, Linearity, Range, Robustness	Approved
VP-0021	Flow Cytometry Cell Viability	Precision, Specificity, Robustness	In Execution

VALIDATION RUNS

Experiments

Capture run-level execution, results, attachments, comments and audit trail.

Run ID	Method	Study Type	Owner	Status	Progress
VR-2024-015	ELISA Potency Assay	Precision Study	D. Jensen	In Progress	70%
VR-2024-014	ELISA Potency Assay	Accuracy Study	M. Chen	Completed	100%
VR-2024-011	CE-SDS Purity	Specificity	R. Patel	Completed	100%

VALIDATION OUTPUT

Validation Report

ELISA Potency Assay · VR-0035

Report Sections

7 of 7 complete

1 · ScopeComplete

2 · Method DescriptionComplete

3 · Validation ParametersComplete

4 · Results SummaryComplete

5 · DeviationsComplete

6 · ConclusionComplete

7 · Approval HistoryComplete

Document Readiness

86%

✓Required sections complete

✓Supporting data linked

✓Reviewers assigned

Final approval obtained

DATA INTEGRITY

Traceability

Follow the evidence chain from method definition to final report.

⚗ Method
MTH-0042

→

▣ Validation Plan
VP-0017

→

▦ Experiment Runs
3 linked

→

▤ Raw Data
12 files

→

✓ Final Report
VR-0035

WORKSPACE

Settings

Configure the Prove It workspace.

Appearance

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Prototype defaults

Default guidelineICH Q2(R2)

Audit trailNot implemented

Electronic signaturesNot implemented

Browser data

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