The Paperless QMS March 2012
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The Paperless QMS
March 2012
© GxPi 2012 2
Overview
• Introductions
• What do we mean by ‘Paperless QMS’?
• Short history of the (pharma) Paperless QMS
• What do you need your Paperless QMS to do?
• Practical application and considerations
• Advantages and Disadvantages
• Practical applications - examples
• Close out and Questions
© GxPi 2012 3
GxPi Overview
“We simplify complex process and technology environments to deliver our customers’
compliance and quality goals in their regulatory framework.
We achieve this through a combination of Services and Products that transfer our expertise
to our customers”.
© GxPi 2012 4
QMS - definition
“The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.”
Source: GAMP Good Practice Guide – IT Infrastructure Control and Compliance
© GxPi 2012 5
QMS - definition
“A Quality Management System (QMS) provides a management framework that gives you the necessary controls to address risks and monitor and measure performance in your business. It can also help you to enhance your image and reputation and enable you to look for improvements through internal and external communications.”
Source: BSI
© GxPi 2012 6
QMS framework models
e.g. QC services company or
contracted-out manufacturing services
Mat
eria
l
Packaging & Labeling
Quality
Man
ufac
turin
g
Facilities & Equipment
Quality Control
Management
Mat
eria
l
Packaging & Labeling
Quality
Man
ufac
turin
g
Facilities & Equipment
Quality Control
Management
e.g. GMP Manufacturer with
contracted-out packaging
© GxPi 2012 7
QMS content – an example
Regulatory framework (GMP example)
Change Control Investigations/CAPA TrainingDocument Control
Specifications Quality Agreements Batch records Stability
Product Complaints Recall Annual Product Review Supplier Audits
© GxPi 2012 8
QMS - content
• The core element is the framework
• The content created is a by-product which is worth having and valued
because of the framework within which it was produced
• The volume of transactions and the increasingly virtual nature of
organisations:
• Increasingly electronic content
• Electronic approvals & workflows
• Overarching document and process control
• Paperless QMS = LESS paper!!!
© GxPi 2012 9
Paperless QMS - history
• Largely mirrors the development of systems overall
• Early days:
• Highly custom systems
• Number of separate (disparate even) systems to meet overall need
• High Total Cost of Ownership
• Inflexible systems, difficult to change, upgrade
• Complex to validate
© GxPi 2012 10
Paperless QMS - history
• Maturity of the market in terms of products leads towards:
• Creation of standard product platforms
• Greater integration between components
• Increased Configurability
• Decreased validation effort due to reduced customisation
• Lower TCO particularly around change, upgrade
© GxPi 2012 11
Paperless QMS - Principle Elements
• Content management components:
• Core Quality Documents – SOPs Policies, Guides, WI etc.
• Methods, Specifications, Master Batch records
• Records e.g. Executed batch records, CoA etc.
• Validation Documents
• All the other documents produced under the QMS framework
© GxPi 2012 12
Paperless QMS - Principle Elements
• Process Management components:
• Document management
• Templates and Forms
• Change Control
• CAPA
• Out of Specification (OOS) & Deviation management
• Complaints
• Training Management & resulting Records
• Audit
© GxPi 2012 13
Understanding your QMS
or
Its mostly a Process issue and the
Content is the smaller end of the deal
Its mostly a Content issue and the
Process is the smaller end of the deal
© GxPi 2012 14
Understanding your QMS
Process Engine
Content Mgt.
More of a balanced situation but the volume
of content is growing
very, very quickly
Perhaps it should be more like this......
© GxPi 2012 15
What do you need your QMS to do?
• Like all Quality related decisions the goal is to create an environment that is
• fit for purpose and right for your business
• not purely driven by the letter of the regulations
• Needs investment in specification definition from all stakeholders, not imposed by a
Quality Department
• It is not just an IT or Quality decision
• An electronic QMS offers access to a high degree of functionality..... BUT - is it all
needed ?
• Pick and choose the modules that add value
• Don’t kill the business with the burden/overhead
© GxPi 2012 16
Major characteristics of the system
• Global reach –
‘real’ or ‘virtual’
• Data driven,
document supported
• Capable of managing
complex issues
• Overarching reporting features:
• Progress to date
• Performance indicators
© GxPi 2012 17
Major characteristics of the system
• Capable of change, without fundamental rebuilding
• Modular
• Building block based
• Tool kit components
• Capable of ‘absorbing’
content from external
sources
• Management of training and
competence demonstration in the QMS
• Support the Audit – in the system or outside ?
• Need for flexible viewing tools to make audit sustainable
© GxPi 2012 18
Benefits of multi-track issue management
Corrective Action
CA
PA
Req
ues
t
Root Cause Analysis Preventative Action CAPA ApprovalCAPA
AuthorisationImplement
Preventative Action Clo
se
Typical linear ‘simple’ single track approach
Au
dit
Fin
din
gC
AP
A R
equ
est
CAPA Issue Initiation
Alt
ern
ate
Entr
y P
oin
ts
Preventative Action
Root Cause Analysis
Corrective Action
ImplementActions
CAPA Approvals
Sub Issue Closure C
lose
Preventative Action
Root Cause Analysis
Corrective Action
ImplementActions
CAPA Approvals
Sub Issue Closure
Preventative Action
Root Cause Analysis
Corrective Action
ImplementActions
CAPA Approvals
Sub Issue Closure
Preventative Action
ImplementActions
CAPA Approvals
Preventative Action
ImplementActions
CAPA Approvals
Root Cause Analysis
Data driven electronic multi stream approach
Overall Process DashBoard and
reporting
© GxPi 2012 19
Automation is not an end in itself
• Two important things to bear in mind
• Automating poor manual systems will not make them good
• Lack of compliance in an electronic paperless system will be clearer, more
starkly visible that ever it was in paper – the audit trail is unwavering
• It needs to be a balance
between the components
• All need to be
• Effective
• Contributing
• Balanced
© GxPi 2012 20
System selection – problems and pitfalls
• Have you got a QMS or is that part of the project?
• Is the goal to automate the current system?
• Or replace it with a complete solution?
• Key going into the project is clarity of
• Scope
• Objectives
• Requirements
• Commitment – across the business
• Timeline & drivers
© GxPi 2012 21
System selection – problems and pitfalls
• Other factors to consider:
• Cost!
• Level of resource to maintain
• Migration of current content
• Organisational Change management - adoption by all
• Validation and compliance
• Ownership
© GxPi 2012 22
Paperless QMS – Practical applications
• Big Pharma
• Part of standard business system portfolio
• Management tool
• KPIs
• Small Pharma / Biotech
• Lower cost of ownership from standard products
• Streamline the system
• Ease the burden to deliver the quality outcomes
• Suited to outsourced / virtualised companies
• Service Provider (such as contract QC lab)
• Management of vendor audit
• Evidence of competence to deliver service
• Access to information about the contract / service
© GxPi 2012 23
Paperless QMS – Conclusions
• Fitness for purpose
• Understand what it is you need your QMS to do for your business (Process and
Content)
• Preparation, preparation, preparation
• Just because functionality is available within an electronic QMS it may not be of
value to you
• Understand the investment in specification, implementation, validation and use
• A poor paper-based system will remain a poor QMS if change is not implemented
© GxPi 2012 24
Products and Services that are
Simply Compliant
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