B3, Introduction to Empower3 Method Validation Manager … · 2013-09-10 · ©2011 Waters Corporation 1 B3, Introduction to Empower3 Method Validation Manager Rune Buhl Frederiksen,

©2011 Waters Corporation 1

B3, Introduction to Empower3 Method Validation Manager

Rune Buhl Frederiksen, Manager, Waters Educational Services


Content

Presentation overview of Method Validation Manager

Live Demo


Prepare Standards & Samples

Data Management

Time consuming, repetitive tasks consisting of several sequential steps Faster and Easier Method Validation

Corporate Method Validation

SOP

Data Acquisition & Processing

Create Sample Sequence

Calculation Statistical Results

Reports Compiled

Method Validation Manager

Analytical Method Validation Process with Method Validation Manager


MVM Functionality

Workflow oriented: — Perform and manage the workflow from Empower - from creating the

validation protocol method through reporting the final results — Minimize the number of injections needed for validation using the

same injections for several tests, or combining several tests into the same sample set.

— Data approvals and automatic data checks ensures the proper raw and processed data is used throughout workflow

— Software tracks the status of each validation test o User can easily see what has been done and determine what they

need to do next o Multiple users can easily manage the study as a cooperative

effort as they readily determine what their peers have done because the Status field tells each user what step each test is at.

o This eliminates the need for colleagues to communicate with each other.

— Customizable Report templates can be used to standardize the report format o Automatic report generation o Ease of Review


MVM Functionality

Features for Regulatory Compliance : — Calculations are structurally validated and performed within Empower

o No data transfer and checking required; No spreadsheets of which to validate functions; No concern regarding security of spreadsheets

— Data is secure in the Empower database o No flat files

— Full Set of User Privileges and access control o For data security

— Fully audit trailed activities are available for any user activity


New Method Validation Manager Option For Empower 3

Method Validation Manager option for Empower 3 Software takes the currently disjointed process of method validation and automates the process within the software.

Incorporates corporate validation requirements in reusable templates that adhere to customer’s SOP.

Realize time savings anywhere from 50% – 80% in this formerly manual and error-prone iterative process.


Create Validation Protocol Method + Sample Set Methods used for each validation test

Workflow of MVM

Create Validation Study

Create Chromatographic Results

Create Validation Results

Print Customized Reports

(optional) Approve Validation Protocol Method

(optional) Approve Sample Sets

(optional) Sign-Off Result Sets

(optional) Sign Off regular and validation results

Acquire Sample Sets

(contains all validation data)


Purpose of Validation Protocol Methods

Validation Protocol Method is used as a generic template (just as the protocol/SOP is generic) and dictates requirements based on: —Compound Type (Drug Substance, Drug Product, Raw Material,

Process Intermediate)

—Analytical Method Type (Potency Assay, Impurity, Content Uniformity, Dissolution, etc.)

—Stage of Development (Development, Phase I, Phase II, Phase III,)

Tip: You can customize the names of these fields

You can open a validation protocol method based on its name or combination of these three fields


Validation Protocol Method

Identifies which Validation Tests have to be run —from 13 different tests

Specifies the configuration of each validation test —Number of levels, injections/level, etc.

Acceptance criteria on any desired results from any/all tests —Much like System Suitability Limits

Sample Set Method(s) which fulfill each validation tests’ configuration parameters (optional) —One sample set method can be used for multiple validation

tests —Multiple sample set methods may be used for one validation

test oEach row in the Sample Set Method is associated with one

or more tests, using checkmarks in the appropriate locations.


Creating a Validation Protocol Method Identify Compound Type

Identify Analytical Method Type Identify Development Type

Set Protocol Comments

Specify Validation Test

Acquisition Parameters (required)

Processing Parameters (required)

Acceptance criteria (optional)

Sample set Method (optional)

Add Validation Test(s)?

System Precision Required?

No

Approval/Signoff Required

Yes

Yes

Save Validation Protocol method

Yes

No Skip System Precision

No Skip Approval Signoff


Test Parameters

3 Parts to configuring a test:

1. Acquisition Parameters

2. Processing Parameters

3. Acceptance Criteria


Acquisition Parameters

Defines the data to acquire.

You can specify whether the acquisition criteria defined for each validation test are exact requirements or minimum requirements. — If you specify exact requirements, laboratory personnel must

acquire data that exactly fulfills the validation acquisition parameters.

— If you specify minimum requirements, laboratory personnel can acquire data that meets or exceeds the acquisition requirements.


Processing Parameters

Identify the component type you want to use and which Empower field(s) you want to statistically assess.

After you use Empower to create chromatographic result sets, you use this data to create validation results.

Empower calculates the chromatographic result sets according to the processing parameters defined in the processing method.

Method Validation Manager uses the chromatographic result sets and the processing parameters listed in the test’s processing parameters to calculate validation results.


Acceptance Criteria (Optional)

Defines the specifications for validation result field values in order to determine whether the validation results are within specification or out of specification (OOS).

You can define the specifications that each validation result must pass in the acceptance criteria tables of the validation protocol method.

Method Validation Manager compares the results of each validation test to the specified acceptance criteria. If the acceptance criteria are not met, it "faults" the validation result. Faulted validation results fields appear in a different font and color in both Validation Review and in your Empower reports.


Creating a Sample Set Method

Sample Set Methods can be created and added to the Validation Protocol Method. —It is possible to leave certain SSM fields blank (even though they are

usually not allowed to be blank in a standard project) to allow variable application and usage of these SSM. These fields are Method Set, Vial#, RunTime and Injection Volume.

—Hence, any Validation Studies created based on this Validation Protocol Method will have the same Sample Set Methods as instructions on how to collect the data. This eliminates duplicating the work of creating the sample set method on each Validation Study based on the same Validation Protocol Method.

—There are checkbox fields that require enabling for each test so that the sample can be used to generate validation results

—The Sample Set Method Editor contains several new fields such as Laboratory Name, the DOE fields, Storage Time, Storage Condition etc., which are used for the various tests.


Sample Editor

Allows multiple validation tests to be performed in one sample set (software knows which injections pertain to which validation test)

Allows legacy data to be used in a method validation study (Validation test designation is added via Alter Sample)

Allows a single row in the Sample Set method to be used for >1 Validation Test.


Create Validation Protocol Method + Sample Set Methods used for each validation test

Workflow of MVM

Create Validation Study

Create Chromatographic Results

Create Validation Results

Print Customized Reports

(optional) Approve Validation Protocol Method

(optional) Approve Sample Sets

(optional) Sign-Off Result Sets

(optional) Sign Off regular and validation results

Acquire Sample Sets

(contains all validation data)


Options for Organization of Validation Studies

Validation Template Project

Validation Protocol Methods

(1) Validation

Study

Validation Protocol Methods

(2) Validation

Study

(3) Validation

Study

Validation Working Project


Validation Study

A Validation Study is the entire set of chromatographic data and results related to a series of validation tests used to validate a method.

A Validation Study is created from a previously defined validation protocol method (or another validation study) by anyone in the laboratory who has the privilege using Method Validation Manager. — Since a validation study is created based on a validation

protocol method, all acquisition parameters and processing and acceptance criteria from the validation protocol method are used.

— Note: There is more information stored in a validation study because a Study includes a validation protocol method plus all of the data collected for that validation protocol method.


Contents of Validation Study

Validation Protocol Method

Protocol Approval (optional)

Sample Set Methods (SSM)

Sample Sets (SS)

Data approvals (optional)

Chromatographic Result Sets (RS)

Result Set Signoffs (optional)

Validation Results (VR)

Validation Results Signoff (optional)

Study Approval (optional)


Create a Validation Study

Approval Required?

Signoff Required?

Signoff Required?

For each test, create & attach one or more Sample set methods

Approval Required?

Create/Attach one or more Result sets

Create validation results

Study Complete

Add or modify a validation test

No

Acquire/Attach one or more Sample sets No

No

No

Approve

Yes

Approve

Yes

Signoff

Yes

Signoff Yes

Approve

Yes

No

All tests complete? No

Study approval Required?

Yes


Validation Workflow

Test Status indicates what step you are at in the workflow


Green √ if the validation results were created successfully, and no errors occurred, and all acceptance criteria are met.

Yellow if the validation results were created successfully and no errors occurred but one or more of the validation results do not meet the acceptance criteria.

Red X if one or more of the validation results generated errors. — An error-type processing code appears for one or more of the

validation results — Not all of the expected validation results were created. — A red X status appears for one or more preceding data items

(result set, sample set, or sample set method).

Different VR Status Results


Different VR Status


Questions ?

Documents

B3, Introduction to Empower3 Method Validation Manager … · 2013-09-10 · ©2011 Waters Corporation 1 B3, Introduction to Empower3 Method Validation Manager Rune Buhl Frederiksen,