Document Management Solution (EDMS)

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Implementing TrackWise with an Electronic

Document Management Solution (EDMS)

Alex Kotikovsky

Product Manager

Sparta Systems

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Gilad Kigel

Manager, Solutions Consulting

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Sparta Systems

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Agenda

Document Management Overview

Agenda

Document Management Overview

Document Management within TrackWise

Benefits of an Integrated Solution

Best Practices

Demo of TrackWise Document Management

Q&A

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Compare/Contrast Document Management

and EQMS

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EQMS Vision

Deviations & Audit Complaint Lab Issues Deviations & Incidents Audit Management Supplier Quality Complaint Handling Adverse Event Management Investigations Investigations Risk Evaluation Risk Evaluation Reporting Product Registration Tracking Training Management Root Cause Analysis Root Cause Analysis CAPA CAPA Commitments Commitments Correspondence Correspondence Change Control Batch / IT / Process / Document Material / Equipment Change Control Batch / IT / Process / Document Material / Equipment Effectivity Analysis Effectivity Analysis

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Typical Document Management

Strategies

Many of our customers have existing document management systems

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Strategies

in place that they want TrackWise to link to:

Other companies that don’t already have EDMS may want to leverage

their EQMS investment to support both. This presentation will focus

primarily on helping these companies understand how TrackWise can

support document management needs

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Intro to Document Management



What is it: fundamentally, the ability to control documentation

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Intro to Document Management

and distribute to appropriate employees



Key features?: revision control and check in/check out

functionality



Some companies distinguish between types of documents



Controlled – SOPs, Policies, Forms, Work Instructions

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− things that require change control approval to be released



Standard or Project documents – meeting minutes, validation

reports, testing summaries, project plans

Do not require change control approval to be released even though some

− Do not require change control approval to be released, even though some

may support change control (e.g., a validation plan may be electronically

approved for CAPA or Change Control but doesn’t require the same

approval steps as an SOP update)

For the purposes of this presentation we will focus on Controlled documents, or those that

require Change Control approval to be released

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Document Management vs. EQMS

Document Management

EQMS

Key feature

Revision control

Workflow management

Key searching capability

Display all SOPs needed to

perform job

Ability to identify trends in

database

Key value proposition

Ensure products are made

per specification and

company operates under

l

Enables closed‐loop

processes

control

Historical tools before

electronic systems

Shared network drive,

paper printouts

Paper with excel tracking

Key risks to process

1. Using outdated

procedures

2. Not knowing procedure

exists

1. Not completing things

in a timely manner

2. Incomplete

documentation

exists

3. Not following

procedure

documentation

3. Bypassing process/ late

documentation

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EQMS

Nonconformity

CAPA

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Document Management vs. EQMS

1.0 Retired

1.0 Effective

1.0 in progress

Document Management vs. EQMS

Approve

WIP

New

SOP

2.0 Retired

2.0 Effective

2.0 in progress

Approve

WIP

Revise

SOP

3.0 Retired

3.0 Effective

3.0 in progress

Approve

WIP

Revise

SOP

4.0 Effective

4.0 in progress

Approve

WIP

Revise

SOP

Discussion point: should documents become effective as soon as they are approved?

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High‐level Change Process



Change request vs. change

High level Change Process

Change request vs. change

management

− Why is the change happening?

Request

− Who does it impact?

− What actions are required?

Regulatory implications?

Assessment

Change

M

t

Change

Request

Regulatory implications?

− What approvals are required?

− Real‐time status?

Pre‐approval

Execution

Management

Post‐approval

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Enterprise Change Control:

Desired State



Hierarchical relationship of one change

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Desired State

Electronic attachment

request and its associated activities



Electronic attachment and organization

of supporting documentation

Change Request

attachment



Logical association of supporting

information directly to change request



Automated, consistent, and efficient

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Impact Assessment Clear i k

change control process



Clear visibility to all levels of the

organization through centralization of

information and dashboards

Regulatory Assessment Linkage

information and dashboards



Accommodation of both proactive and

reactive change activity

Implementation Activities

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TrackWise Document Management

Options

TrackWise file attachments:

Options

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se

e attac

e ts



Leveraging repository to securely store and associate

documents to TrackWise records.

Document Management Connector:



Integrate with existing content solutions (ex: Documentum,

SharePoint, LiveLink)

Integrated EQMS and Document Management:



A single, integrated solution to relate content management

processes directly to EQMS (CAPA, Change Control,

Regulatory Correspondence Auditing Training etc )

Regulatory Correspondence, Auditing, Training, etc..)

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TrackWise Document Management

Key Features



Workflow

Key Features



Automation



Check‐in and Check‐out



Version Control



Access Control

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

Escalations



Notifications



Auto Embedding of Metadata



Auto‐Embedding of Metadata



Search and Query

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Benefits of an Integrated Solution

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Typical Quality Process



Data received and monitored by EQMS

Typical Quality Process

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

Deviation or anomaly detected



Analysis preformed as directed

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

Interpret, document, and discuss results



Modify processes and documentation as appropriate

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

Publish and audit system changes

Cause

Cause and

and

correction

analysis

performed

Publish and

Quality

information

tracked and

monitored

Deviation

logged into

system

Ad hoc

review and

discussion of

results

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TrackWise Document Management

and EQMS

Lab Issues Deviations & Audit Complaint Lab Issues Incidents Management Supplier Quality Management Investigations Investigations Handling Adverse Event Reporting Investigations Investigations Risk Evaluation Risk Evaluation Root Cause Analysis Root Cause Analysis Document Control Training

Management _CAPA_CAPA

Change Control Batch / IT / Process / Document Change Control Batch / IT / Process / Document Effectivity Analysis Effectivity Analysis Material / Equipment Material / Equipment

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Benefits of Integrated TrackWise

EQMS & EDMS



Ensure compliance through document control

EQMS & EDMS

Ensure compliance through document control



Seamless integration



Reduced training cost



Reduced training cost



Improved system performance

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Case Study:

NVI (Netherlands Vaccines Institute)

Business Challenge

NVI (Netherlands Vaccines Institute)



Its previous system for managing records – a combination of Microsoft

Excel, Microsoft Access and old‐fashioned, paper‐based methods – had

become insufficient for managing documentation and readying reports for

submission to the EU.



NVI decided to seek out a centralized electronic system for document

management that would not only ensure efficient and effective compliance

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with reporting standards, but also seamlessly integrate with its current

systems

Why TrackWise

• Compliant with European Standards, easy to generate submission

reports

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Why TrackWise

• Compliant with European Standards, easy to generate submission

reports

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• Easy integration with other systems, minimal configuration

• Ease of use, intuitive GUI

• Easy integration with other systems, minimal configuration

• Ease of use, intuitive GUI

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Results

NVI Implementation

Results:

NVI Implementation



NVI was able to create a centralized repository for

all its critical documents, immediately migrating more than

20,000 documents into its new system, and eventually doubling

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that number to 40,000 over the next two years.

− Leveraging and Expanding TrackWise Investment beyond Document

Management:

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− Addition of 13 workflows within it its quality assurance department,

including:

• _Deviations

• Corrective and Preventive Actions (CAPA)

• _{Change Control}

• Internal and External Audits

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Best Practices

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Best Practices



All linked processes in a single system

Best Practices

All linked processes in a single system



Notifications on Sunset Dates, Updated Content, etc



Dashboards of document state and status



Dashboards of document state and status



Document Templates for consistency and repeatability



Use the EDMS Connector to leverage an existing

investment

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Documents in a Corporate Hierarchy

• SOP

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• Work Instructions

• Policies

• Batch Records

• Regulatory

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Submissions

• Correspondences

• CAPA Evidence

• Validation Docs

• Manuals

• Instructions

• Investigation

Reports

• Audit Reports

• Product

Registrations

• Plus more

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How Do Companies Manage The

Complexity?

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Define, Track, Manage and Report

Across Your Organization

Complaint

Manufacturing site conducts an investigation to determine

Investigation



Complaint Entry



Initial Assessment and

Data Collection



Send notification to

Customer called

about missing

instr ctions

cause of problem

_

_{Trend Detection}



Root Cause Determination



CAPA Determination

QA for impact Analysis



Immediate Action

Taken

instructions

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Define, Track, Manage and Report

Across Your Organization

Quality Assurance

Effectiveness

Check

Quality Assurance

Need to continuously verify effectiveness of CAPA

CAPA

Quality Assurance

Add procedure to verify instructions included before shipping