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Migration

 

of

 

Controlled

 

Do ments into

Documents

 

into

Compliant

 

SharePoint

 

Document

 

Management

Systems

Presented

 

by:

Joe

 

Lucadamo

F

d C

l i

Focused

 

Consulting

(2)

The

 

views

 

and

 

opinions

 

expressed

 

in

 

the

 

following

 

PowerPoint

 

slides

 

are

 

those

 

of

 

the

 

individual

 

presenter

 

and

 

should

 

not

 

be

 

attributed

 

to

 

Drug

 

Information

 

Association,

 

Inc.

 

(“DIA”),

 

its

 

directors,

 

officers,

 

employees,

 

volunteers,

 

members,

 

chapters, councils, Special Interest Area Communities or affiliates, or any

chapters,

 

councils,

 

Special

 

Interest

 

Area

 

Communities

 

or

 

affiliates,

 

or

 

any

 

organization

 

with

 

which

 

the

 

presenter

 

is

 

employed

 

or

 

affiliated.

 

These

 

PowerPoint

 

slides

 

are

 

the

 

intellectual

 

p p

property

y

 

of

 

the

 

individual

 

presenter

p

 

and

 

are

 

protected

 

under

 

the

 

copyright

 

laws

 

of

 

the

 

United

 

States

 

of

 

America

 

and

 

other

 

countries.

  

Used

 

by

 

permission.

  

All

 

rights

 

reserved.

 

Drug

 

Information

 

Association,

 

DIA

 

and

 

DIA

 

logo

 

are

 

registered

 

trademarks

 

or

 

trademarks

 

of

 

Drug

 

Information Association Inc All other trademarks are the property of their

Information

 

Association

 

Inc.

  

All

 

other

 

trademarks

 

are

 

the

 

property

 

of

 

their

 

respective

 

owners.

 

(3)

What

 

is

 

This

 

Presentation

 

About?

Overview of SharePoint

Overview

 

of

 

SharePoint

What

 

it

 

is,

 

how

 

it’s

 

structured

To provide framework for this presentation

To

 

provide

 

framework

 

for

 

this

 

presentation

The

 

migration

 

process

(4)

What

 

is

 

This

 

Presentation

 

Not

 

About?

How to configure SharePoint

How

 

to

 

configure

 

SharePoint

How

 

to

 

validate

 

SharePoint

S

ifi

fi

d

i d Sh

i

Specific

 

configured

 

or

 

customized

 

SharePoint

 

(5)

Presentation

 

Assumptions

SharePoint is validated

SharePoint

 

is

 

validated

SharePoint

 

implementation

 

meets

 

some

 

or

 

all

 

of the regulatory requirements for compliance

of

 

the

 

regulatory

 

requirements

 

for

 

compliance

 

(6)

Key

 

Terms:

 

Traditional

 

EDMS

 

vs.

 

SharePoint

 

Traditional

 

EDMS

• Current

 

market

 

leaders

 

in

 

EDMS

• Documentum solutions,

 

QUMAS

 

SharePoint

• Microsoft

 

EDMS,

 

collaboration,

 

and

 

web

 

site

 

software

, Q

DocCompliance,

 

Pilgrim,

 

MasterControl,

 

etc.

• Typically

 

dedicated

 

to

 

compliance

 

EDMS solutions

• Highly

 

configurable

 

but

 

not

 

out

of

the

box

 

dedicated

 

compliance

 

EDMS

• FDA

regulated

 

industries

 

showing

 

increasing interest in SharePoint

EDMS

 

solutions

• Key

 

Terms:

• Document

 

as

 

a

 

combined

 

object

 

(content,

 

renditions,

 

metadata,

 

increasing

 

interest

 

in

 

SharePoint

• Key

 

Terms:

• Document

 

as

 

multiple

 

objects

• No

 

PDF

 

renditions

previous

 

versions)

• PDF

 

Renditions

• Content

 

Databases:

 

Oracle,

 

MSSQL

(7)

Migrations

 

from

 

One

 

Traditional

 

EDMS

 

to

 

Another

Traditional EDMS

Different Traditional EDMS

Traditional

 

EDMS

Different

 

Traditional

 

EDMS

(8)

Migration

 

from

 

Traditional

 

EDMS

 

to

 

SharePoint

Traditional EDMS

SharePoint

Traditional

 

EDMS

SharePoint

(9)

Traditional

 

EDMS

 

Document

 

Objects

Traditional

 

EDMS

 

D

t Obj t

Document Object

Document

 

Object

Document

 

Object

Native

 

Content

An electronic “document” consists of 

native content, metadata, signature 

data, and a dynamically generated PDF 

Metadata

rendition.

This is represented as one document 

object in the system – the user sees 

onl one entr

Signature

 

Data

only one entry.

Whereas in standard SharePoint 

systems…

(10)

SharePoint

 

Document

 

Objects

Document

 

Object

 

1

Document

 

Object

 

2

Document  Object Document  Object Native  Content Metadata PDF Content Metadata Metadata Metadata Signature  Data Signature  Data

(11)

Traditional

 

EDMS

 

Architecture

Traditional

 

EDMS

 

A hit t

PDF Render

Other EDMS

Architecture

PDF

 

Render

 

Solution

Other

 

EDMS

 

Components

Custom solutions that sit directly on a 

database layer. 

EDMS Solution

These solutions are designed to meet 

compliance requirements for FDA‐

regulated industries.

EDMS

 

Solution

Traditional EDMS products typically 

have an integrated PDF render 

solution.

(12)

SharePoint

 

Architecture

Sh

P i t A hit t

PDF

 

Render

 

Other

 

EDMS

 

SharePoint

 

Architecture

Solution

Components

SharePoint is a standardized EDMS 

platform, that is designed to meet 

generic document management 

EDMS

 

Solution

needs.

Customized EDMS solutions sit on top 

of the SharePoint platform to meet 

ind str specific req irements

SharePoint

SharePoint

 

API

industry‐specific requirements. SharePoint does not provide an 

integrated PDF render solution.

MSSQL

 

Database

The SharePoint API is used to interact 

programmatically with the SharePoint 

(13)
(14)
(15)

Migration

 

Process

 

Stages

Export

Transform

Load

Export

Transform

Load

Compliance

 

complexity

 

is

 

the

 

greatest

 

at

 

the

 

Transform

 

stage

(16)

Export:

 

Introduction

Exporting from an existing solution is

Exporting

 

from

 

an

 

existing

 

solution

 

is

 

straightforward,

 

provided

 

you

 

account

 

for

 

the

 

following key components:

following

 

key

 

components:

• Document

 

metadata

• Document

 

content

 

(native

 

and

 

renditions)

• Electronic

 

signatures

• Change

 

Request

 

history

• Audit

 

information

(17)

Export:

 

Risks

 

&

 

Mitigation

D

t

• Proper

 

requirements

 

definition

• Content

 

counts

 

to

 

verify

 

source

 

and

 

exported

 

documents

Documents

 

Missed

• Clean

up

 

in

 

the

 

source

 

system,

 

if

 

possible

• Clean

up during the Transform stage

Corrupted

 

Clean up

 

during

 

the

 

Transform

 

stage

• Customize

 

destination

 

system

 

to

 

work

 

with

 

available

 

data

Data

• Establish

 

timeline

 

to

 

close

 

out

 

all

 

open

 

revision

 

cycles

 

in

 

the

 

(18)

Transform:

 

Introduction

The work of transforming

The

 

work

 

of

 

transforming

 

data

 

requires

 

the

 

skills

 

of:

Subject Matter Experts

Subject

 

Matter

 

Experts

Technical

 

Experts

Y

t t

f

You

 

cannot

 

transform

 

your

 

data

 

until

 

you

 

know

 

what

 

it

 

i

d h

it i

i

(19)

Transform:

 

Planning

• What

 

business

 

requirements

 

are

 

driving

 

this

 

new

 

implementation?

• What changes would you

like to

make in

Business

 

Requirements

What

 

changes

 

would

 

you

 

like

 

to

 

make

 

in

 

the

 

new

 

system?

Requirements

• What

 

changes

 

do

 

you

 

have

 

to

 

make

 

to

 

the

 

data to meet new system requirements?

Technical

data

 

to

 

meet

 

new

 

system

 

requirements?

• What

 

can

 

you

 

do

 

in

 

the

 

new

 

system

 

that

 

Technical

 

(20)

Transform:

 

Typical

 

Business

 

Requirements

Document Type

Custom Attribute

Document

 

Type

 

Consolidation

• Streamline

 

system

 

configuration

• Revise design to

Custom

 

Attribute

 

Cleanup

• Modify

 

existing

 

values

 

to

 

meet

 

new

 

syntax

Existing

 

Attributes

• Map

 

existing

 

attributes

 

to

 

new

 

attributes

New

 

Attributes

• Determine

 

rules

 

for

 

populating

 

new

 

attributes

• Revise

 

design

 

to

 

meet

 

current

 

business

 

needs

syntax

• Correct

 

data

 

inaccuracies

attributes

• Identify

 

attributes

 

to

 

be

 

brought

 

over

 

“as

is”

• Identify

 

attributes

 

attributes

• Assign

 

SMEs

 

to

 

generate

 

the

 

new

 

data

to

 

be

 

transformed

Proper

 

planning

 

at

 

this

 

stage

 

is

 

critical

 

to

 

defining

 

the

 

scope

 

of

 

the

 

migration

 

effort.

 

(21)

Transform:

 

Typical

 

(Hidden)

 

Technical

 

Requirements

Critical

 

Compliance

 

Data

• Document

 

Names/Numbers

• Document Titles

New

 

Required

 

Data

• New

 

mandatory

 

system

 

attributes

• New system

Data

 

Type

 

Matching

• Special

 

characters

• Date/DateTime matchups

D t

l

• Document

 

Titles

• Document

 

relationships/references

• Signatures

R

diti

• New

 

system

 

architecture/functions

• Data

 

cleanup

• Renditions

The

 

technical

 

team

 

should

 

review

 

these

 

key

 

requirements

 

and

 

provide

 

feedback

 

to

 

(22)

What

 

About

 

Electronic

 

Signatures

 

on

 

Exported

 

Content?

• Content

 

may

 

be

 

migrated

 

as

is

• Some

 

banding/watermarking

 

may

 

need

 

to

 

be

 

d

d i

t

PDFs

 

Contain

 

done

 

during

 

export

Signatures

• A

 

tool

 

may

 

be

 

needed

 

to

 

extract

 

metadata

 

signatures and fuse them to the exported PDF file

PDFs

 

Do

 

N t

C

t i

• Rely

signatures

 

on

 

a

 

custom

 

and

 

fuse

 

SharePoint

 

them

 

to

 

 

the

solution

 

exported

 

to

 

replicate

 

PDF

 

file

 

the

 

functionality

 

of

 

the

 

legacy

 

system

Not

Contain

 

Signatures

(23)

Transform:

 

Risks

 

&

 

Mitigation

• Proper

 

requirements

 

definition

• QA

 

Verification

 

Plan

• Automated

 

data

 

verification

 

against

 

destination

 

system

Improper

 

Data

 

Transformation

• Manual

 

correction

 

of

 

content

f

bl d

Content

 

Corruption/Missing

• Mitigation

 

strategy

 

for

 

unrecoverable

 

documents

Corruption/Missing

 

Data

• Make

 

corrections

 

in

 

the

 

Source

 

System

 

prior

 

to

 

export

• Automate

 

transformation

 

as

 

much

 

as

 

possible

(24)

Transform:

 

Compliance

Validate

• Validate

 

all

 

tools

• Validate

 

the

 

process

Rules

QA Approval

Rules

• Document

 

transformation

 

rules

QA

 

Approval

• QA

 

sign

off

 

on

 

all

 

transformed

 

metadata

rules

(25)

Transform:

 

Key

 

Pitfalls

 

to

 

Avoid

Electronic

Rendition

d

Electronic

 

Signatures

• How

 

are

 

Rendition

 

Management

• Do

 

all

 

content

 

Metadata

• Will

 

all

 

signatures

 

manifested

 

in

 

the

 

current

 

files

 

have

 

PDF

 

renditions

 

for

 

controlled

 

attributes

 

exist

 

in

 

the

 

next

 

system?

system?

 

• Are

 

they

 

applied

 

to

 

renditions

 

on

 

viewing?

 

• Do

 

they

 

need

 

to

 

be

 

modified

 

for

 

• How

 

will

 

the

 

values

 

for

 

new

 

attributes

 

be

 

the

 

fly,

 

or

 

stored

 

in

 

the

 

storage

 

in

 

the

 

new

 

system?

(26)

Load:

 

Introduction

• Importing

 

to

 

SharePoint

 

requires

 

planning

 

for

 

how

 

and

 

where

 

Planning

you’ll

 

store

 

your

 

data

• Standard,

 

base

 

SharePoint

d h

l

Load

• Customized

 

SharePoint

 

solutions

• COTS

 

EDMS

 

SharePoint

Load

 

(27)

Load: Where is Data Loaded?

Other EDMS

Render

 

Solution

Other

 

EDMS

 

Components

SharePoint

Load

 

utilities

 

via

 

talk

 

the

 

 

to

API

 

EDMS

 

Solution

SharePoint

SharePoint

 

API

(28)

Load:

 

Understanding

 

Content

 

Requirements

Previous

 

Versions

• Determine

 

if

 

Native

 

Content

• Migrated

 

PDF

 

Renditions

• Understand

 

Permissions

• Document

 

previous

 

versions

 

are

 

required

 

in

 

the

content

 

may

 

look

 

different

 

than

 

content

 

created in the

the

 

rendition

 

management

 

solution

• Ensure your

permissions

 

must

 

be

 

set

 

by

 

the

 

API

 

during

 

import

the

 

compliance

 

SharePoint

 

EDMS

h b

created

 

in

 

the

 

new

 

system

• Metadata

 

gets

 

fused

 

into

 

d

• Ensure

 

your

 

migrated

 

PDFs

 

won’t

 

be

 

overwritten

 

h

h

import

• They

 

should

 

match

 

library

 

and

 

content

 

• Can

 

this

 

be

 

stored

 

in

 

an

 

archive?

document

 

properties

 

for

 

all

 

documents

 

they

 

have

 

signatures

 

embedded!

type

 

settings

(29)

Load:

 

Things

 

to

 

Consider

How are Renditions 

Managed? • Unlike a traditional  EDMS content Historic Electronic  Signatures • If they’re on the PDF,  you need to Are Documents 

Keeping Their Version 

Number?

• SharePoint doesn’t 

allow the manual

Data Verification

• All good migration 

tools verify data EDMS, content 

objects in SharePoint 

will always exist 

independently • Will both the native 

d PDF diti b

you need to 

understand the 

render solution • If they’re metadata 

only, how will they 

if t Eff ti

allow the manual 

setting of a version 

number via the API • To load a document 

as v4.0, the import 

t l t h k

tools verify data 

against a 

configuration prior to 

load

• Ensure that: and PDF rendition be 

loaded to the same 

library? 

• How are the native 

and PDF rendition 

l k d

manifest on Effective 

copies?

tool must check a 

document out and in 

4 times to set the 

version label to 4 • This will add to the 

l d

• All required fields 

are completed • All of the fields 

match the target 

data type linked? load time • Any listdriven 

(30)

Load:

 

Archiving

 

Options

Legacy

 

System

Database

File

 

Share

SharePoint

• Keep

 

system

 

running

• Limited

 

b

f

• Metadata

• Content

 

files

 

either

 

in

 

DB

 

fil

h

• Spreadsheet

 

of

 

metadata

• Content

 

Fil

• Simple

 

library

 

with

 

“text”

 

metadata

number

 

of

 

licenses

or

 

file

 

share

• Accessible

 

via

 

report

Files

metadata

• Content

 

files

 

are

 

stored

 

directly with

directly

 

with

 

metadata

(31)

Quality

 

Oriented

 

Migration

 

Phases

Plan

Development

Validate

Migrate

Overall

 

Project

 

Planning

Migration

 

Utilities

Export

Overall

 

Technical

 

Analysis

Create/Modify

 

Utilities

 

Based

 

on

 

Requirements

Transform

Requirements

 

q

Migration

 

Process

(32)

Data

 

Migration

 

Validation

 

Deliverables

Plan

Develop Validate

Migrate

Data Migration  Plan Data Migration  Test Protocol •Export •Transform •Load Data Migration  Utilities •Load

•Post‐Load Verification

Migrated  Production Data Data Migration  Requirements Data Migration  Summary Report

(33)

Key

 

Data

 

Migration

 

Validation

 

Deliverables

Data Migration

Data Migration

Data Migration Test

Data Migration

Data

 

Migration

 

Plan

• Outlines

 

the

 

approach

E l i

th

Data

 

Migration

 

Requirements

• Detailed

 

export

 

requirements

D t il d i

t

Data

 

Migration

 

Test

 

Protocol

• Protocol

 

Wrapper

• Export

 

Test

 

Script

Data

 

Migration

 

Summary

 

Report

• Documents

 

results

 

of

 

Data

 

Migration

• Explains

 

the

 

source

 

and

 

destination

 

systems

• Defines roles and

• Detailed

 

import

 

requirements

• Field

 

mapping

• Guides

 

d

l

t f

• Transformation

 

Verification

 

Script(s)

• Load

 

Verification

 

S i t

Migration

 

validation

 

testing

• Prerequisite

 

of

 

releasing

 

system

 

to production

• Defines

 

roles

 

and

 

responsibilities

development

any

 

custom

 

tools

 

of

 

• Provides

 

traceability

 

for

 

Data Migration

Script

• Error

 

Handling

 

Check

• Post

Load

 

Processing

to

 

production

Data

 

Migration

 

(34)

Succeeding

 

in

 

Your

 

Migration

Plan

Prepare

Process

Prosper

Plan

Prepare

Process

Prosper

(35)
(36)

Questions

Joe

 

Lucadamo

References

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