Navigating the Complexity of Life Science

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2 Δεκ 2013 (πριν από 3 χρόνια και 6 μήνες)

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Navigating the Complexity of Life Science
Compliance

Riya

Cao


Director Vertical Marketing, QAD

Ray Greenwood, VP Consulting Services, Strategic Information Group



Life Science Compliance

1

2


The following is intended to outline QAD’s general
product direction. It is intended for information
purposes only, and may not be incorporated into
any contract. It is not a commitment to deliver
any material, code, functional capabilities, and
should not be relied upon in making purchasing
decisions. The development, release, and timing
of any features or functional capabilities
described for QAD’s products remains at the sole
discretion of QAD.

Safe Harbor Statement

Life Science Compliance


Introductions


Compliance challenges


What is validation?


Planning your upgrade with validation in
mind


QAD life sciences update


Agenda

Life Science Compliance

3


600
+

Accounts in 64 Countries



21 New Accounts FY10



24 New Accounts FY11



27% Revenue increase FY11

QAD Life Sciences At
-
A
-
Glance

Life Science Compliance










APAC
18%
EMEA
35%
Lamer
7%
Namer
40%
Medical
Device
51%
Pharma
Biotech
37%
Other
12%
4

Regions

Sectors

Life Sciences Sample Customers

5

Meeting Life Sciences Industry Requirements

Life Science Compliance

Customer Satisfaction


Configured
products


After
sales
s
ervices


Returned
goods


Complaints

Quality
Accountability


Product
s
afety


In
-
coming
inspection


Supplier
performance

Supply Chain Distribution



Contracts



Packaging &
l
abeling



EDI

Regulatory Compliance


cGMP


FDA 21 CFR Part 11


European Commission
Annex 11


ePedigree


GAAP, SOX, IFRS

6

Suppliers

Finished
Product

Mfgr

Distribution
Channels

Customers

7

Winner of Best White Papers Category

http://www.qad.com/erp/Life
-
Sciences/

8


Security


Audit trails


Electronic signatures


Training


Supporting procedural infrastructure


Computer system validation

21 CFR Part 11 / Annex 11

Life Science Compliance


Enhanced security


Audit trails


E
-
Signatures

QAD Enhanced Controls

Life Science Compliance

9

QAD Enterprise Applications

QAD Enhanced Controls

Audit trails

e
-
Signatures

Enhanced
security

Sarbanes
-
Oxley infrastructure

21 CFR Part 11

10


Security


Audit trails


Electronic signatures


Training


Supporting procedural infrastructure


Computer system validation

21 CFR Part 11 / Annex 11

Life Science Compliance

11

Training & Procedural Control

Life Science Compliance

Life Sciences Easy On Boarding

12


25 processes


230+ Work Instructions


137 Compliance points


30 Training links


Training & Procedural Control

13


Security


Audit trails


Electronic signatures


Training


Supporting procedural infrastructure


Computer system validation

21 CFR Part 11 / Annex 11

Life Science Compliance

14

What is Validation?
Proof That a System Is
“Performing As Designed”

STRATEGIC INFORMATION GROUP

QAD Validation Product Partner


All production and/or quality system software

should have
documented requirements that fully define its intended
use, and information against which testing results and other
evidence can be compared,
to show that the software is
validated for its intended use













Food & Drug Administration





A Definition for FDA Validation

Life Science Compliance

15


System development lifecycle policy for computer related systems

-
SOP describing the lifecycle for the acquisition, development, implementation,
upgrade and retirement of software applications and computerized systems.


User specification/requirements
-
high level

-
Created as an aide for the software selection process


Computer system validation plan

-
Is system specific and defines the scope, approach, tasks, roles, responsibilities, testing
environment and acceptance criteria for the computer system.


Hardware Installation Qualification (IQ) protocol

-
Verify and document that all critical aspects of the server installation adheres to
company specifications and manufacturer’s specifications.


Software Installation Qualification (IQ) protocol

-
The purpose of this protocol is to provide documented evidence to a high degree of
assurance that the QAD enterprise applications software application has been
installed in accordance with vendor specifications and company requirements.

Validation Deliverables and Definitions

Life Science Compliance

16


Configuration baseline

-
Modules implemented

-
Control file settings

-
GMP related item status codes, inventory status codes

-
Sets the stage for change control


System design requirements

-
Define the intended use of the system

-
Generated by evaluating user requirements against intended use of QAD, cGxP and
Sarbanes
-
Oxley requirements.

-
If the software is configurable, off the shelf software, and the configuration will be
done in an iterative fashion, the software design specification may be omitted.


Functional requirements

-
Define the intended use of the system.

-
Generated by evaluating the user specification/requirements document against the
intended use of the system.

-
Describe the functions that the system will perform.


Validation Deliverables and Definitions

Life Science Compliance

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Functional specification

-
Define the intended use of the system in support of the functional requirements

-
Process flows/design document


Part 11 assessment

-
21 CFR part 11 compliance assessment


Risk assessment/hazard analysis

-
Identify and evaluate cGxP risks for the QAD ERP system.


Operational Qualification (OQ) protocol/test scripts

-
Provide documented verification that a system operates according to written and
pre
-
approved specifications throughout all specified operating ranges and may
include testing outside operational ranges.

-
Discrete test scripts


Performance Qualification (PQ) protocol/test scripts

-
Provide documented verification that the system is capable of performing and
controlling the activities of the process it is required to perform or control while
operating in its specified operating environment.


Validation Deliverables and Definitions

Life Science Compliance

18


Stress test

-
Verify and document that the QAD system performance is acceptable to all
company locations while operating under typical load conditions.


Traceability matrix

-
Matrix that ties user requirements, functional requirements, user instructions, OQ test
scrip document ID and test number.


Data migration Installation Qualification (IQ) protocol/test scripts

-
The IQ provides documented evidence that cGxP related data was successfully
loaded by comparing source and target reports/files.


Validation final report

-
Review/summary of all validation deliverables. Sign
-
off that the system is approved.




Validation Deliverables and Definitions

Life Science Compliance

19


STRATEGIC INFORMATION GROUP

QAD Validation Product Partner

21

Planning Your Upgrade With Validation In Mind

22


Determine scope

-
Technical upgrade only with new .NET UI and
QAD EE


Rely on QAD release notes for guidance on
enhancements with potential compliance impacts


Rely on QAD ECO information for guidance on fixes with
potential compliance impacts

-
Upgrade and implement new
modules/functionality


Validation Approaches When Upgrading

Life Science Compliance

23


Option
A:
Revalidate everything

-
Draft required new/revised cGxP related functional
requirements.

-
Identify previous functional requirements that may be
affected by product enhancements or eco’s.

-
Combine the above with previous functional requirements

-
Perform risk assessment on all of the above functional
requirements.

-
Write and execute OQ protocol/test scripts for medium or
high risk requirements

-
Re
-
execute PQs.


Validation Approaches When
Upgrading

Life Science Compliance

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Option B:
Leverage
previous validation packages

-
Draft required new/revised
cGxP
related functional
requirements.

-
Identify previous functional requirements that may have be
affected by product enhancements or ECO’s.

-
Perform risk assessment on the above new/revised or
affected functional requirements.

-
Write and
execute
OQ
protocol/test
s
cripts
for medium or
high risk requirements

-
Re
-
execute PQs.


Validation Approaches When Upgrading

Life Science Compliance

25

Where Do I Find Release Notes and
ECO Information
?

Life Science Compliance


support.qad.com


QAD Release Notes

Computer System Validation

26

QAD Release Notes

Computer System Validation

27

QAD Release Notes Sample

Computer System Validation

28

QAD ECO Information

Life Science Compliance

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QAD ECO Information

Life Science Compliance

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Computer systems validation plan


Hardware installation qualification


Software installation qualification


User/functional requirements


Validation Deliverables to
Consider

Life Science Compliance

31


Risk assessment


Operational qualification protocol/test
scripts


Performance qualification protocol/test
scripts


Baseline configuration

Validation Deliverables
To Consider

Life Science Compliance

32


Backup & restore protocol/test scripts


Traceability matrix


Stress test


Data migration plan/protocol

-
Possibly was not part of the initial
validation


Validation final report

Validation Deliverables to
Consider

Life Science Compliance

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QAD Life Sciences Update

Life Science Compliance

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35

Serialization

Life Science Compliance

Packaging Line
Product Serialization
EPCIS
Data
Collection
Print Packer
/
Case
/
Pallet
labels
Wholesaler EPCIS
Distributor EPCIS
Retailer EPCIS
RxASN
Wholesaler ERP
Distributor ERP
Retailer ERP
ePedigree
ePedigree
Pedigree
Messaging
Serialized
Inventory
Mgmt
Pick
/
Pack
/
Ship

Qualified environment including

-
Qualified IT infrastructure


Hardware (IQ/IR)


Operation systems (IQ/IR )


QAD enterprise applications (IQ/IR)

-
Qualified processes


18 SOPs

-
Qualified personnel


Extensive experience in admin & network


Employees trained to SOPs


Training records





On Demand LS Edition

Life Science Compliance

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Corrective and
Preventative
Actions

Records,
Documents,
Change Controls

Equipment and
Facility Controls

Production and
Process Controls

Material Controls

Design Controls

Meeting FDA QS Requirements

Life Science Compliance

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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm

EAM

QAD EA

QMS

PLM

QAD EA

QMS

QAD EA

Management

38

Metrics Affected

Life Science Compliance

Process

Benefit

Value



On

Demand

Risk

mitigation

Scalability

Qualified environment

Compliance

Best

practice IT Administration


䍯C灵p敲

卹St敭eV慬i摡dion

䍆刲C 偡Pt ㄱ 䍯Cpli慮ae


Risk based

Industry

validation best practice

39


Ask your account manager to arrange an
Upgrade Q−Scan


On Demand Q−Scan


Stop by the Strategic booth


Attend Thursday morning QMS presentation


QAD Life Sciences website
http://www.qad.com/erp/Life
-
Sciences/



Next Steps

Life Science Compliance

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Riya

Cao:
zrc@qad.com


Ray Greenwood:
rayg@strategic.com


Questions & Answers

Life Science Compliance


www.qad.com

© QAD Inc

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