SharePoint for Pharma - Computer System Life Cycle Management

SharePoint for Pharma -
Computer System Life Cycle
Management

Presented by
Michael Zwetkow
Pharmaceutical IT
Project Leader

June 04th 2010

www.montrium.com COPYRIGHT MONTRIUM 2010

Recap of last
webinars
• SharePoint and 21 CFR Part 11 – we saw the approaches being
taken by companies to validate their SharePoint environments, and
emerge with a set of guidelines for a risk-based validation strategy
for SharePoint
• Effective Configuration Management – we saw the various
elements of the system that must be managed under configuration
control as well techniques and tools that can be used to facilitate
this requirement
• Extracting Actionable Intelligence from SharePoint – we saw
how GxP operational components can be organized and connected
to act as a Business Intelligence (BI) and Business Process
Management (BPM) solution that integrates people, platforms and
processes and delivers actionable intelligence back to the
organization.

www.montrium.com 2
COPYRIGHT MONTRIUM 2010

Webinar Overview
• Introduction to the GAMP 5 Life Cycle Approach
• Activities for achieving and maintaining
compliance of IT systems within a regulated GxP
environment
• The challenges of faced during each phase of the
Computer System Life Cycle
• Overview of how SharePoint can be configured to
help maintain control and manage changes made
to validated systems
• Demo of Montrium’s SharePoint based Computer
System Life Cycle (CSLM) Workspace:
• System Inventory
• System Documentation
• IT Change Control Process


GAMP 5 Life Cycle
Approach
• Defining activities in a systematic way from system
conception to retirement
• Forms an intrinsic part of the company's QMS
• Activities should be scaled according to:
• system impact on patient safety, product quality, and data
integrity
• system complexity and novelty
• outcome of supplier assessment


Benefits of a defined
process
• Systems that are implemented according to a well
defined process often have the following benefits:
• Ensures system is fit for intended use
• Reduces cost and time
• Enables early defect identification and resolution
• Improves change management
• Promotes continuous improvement
• Promotes common system life cycle, language, and
terminology
• Provides practical guidelines and examples
• Allows pragmatic interpretation of regulations


Life Cycle Phases
and Activities

Concept Project Operation Retirement

• Develop • Planning • System • Data
Initial • Supplier Maintenance Retention
Requirements assessment • Functional • Migration
• Identify and selection Change • System
potential • Specification Management Withdrawal
solutions & • Configuration
Configuration Change
• Verification Management
• Report &
Release


GAMP 5 – Systems
Management
Establishing computerized systems compliance policies and procedures

Identifying roles and responsibilities
Quality
Management
Training

Managing supplier relationships

Maintaining a system inventory

Life Cycle
Management Planning for validation

Change management & continuous improvement activities


Computerized Systems
Policies and
Procedures
• Identify and comply with all applicable GxP
requirements
• Integrate life cycle activities into the regulated
company's QMS
• Identify and assess each system
• Ensure GxP regulated systems are compliant and fit
for intended use according to established SOPs
• Follow a validation framework, including the use of
validation plans and validation reports
• Maintain compliance throughout the life of a system

Source: GAMP5

Identifying Clear
Roles and
Responsibilities
• Key responsibilities include:
• Defining, approving, and maintaining policies
and SOPs
• Compiling and prioritizing the system
inventory
• Producing plans and reports
• Managing compliance and validation activities
• Maintaining compliance during operation

Source: GAMP5

Training
• Establish and provide the necessary training
• Evaluate the effectiveness of the training
• Ensure that supplier staff are adequately
trained, e.g., as part of supplier assessment
• Maintain appropriate training records
• Ensure training is maintained up to date
following system changes

Source: GAMP5


Managing supplier
relationships
• Ensure internal and external suppliers are made
aware of the need for regulatory compliance
• Verify the supplier has adequate expertise and
resources to support user requirements and
expectations

Source: GAMP5


Maintaining the
System Inventory
• Maintain an inventory of GxP
computerized systems provide summary
information such as:
• Validation status
• Ownership
• Impact (Functional Area affected)
• Current system version
• Supplier/Vendor

Source: GAMP5


System Inventory

System Description
System
Validation
State
Functional Areas
System
Owner &
Admin

COTS
CSV Pack
Components
Feature Web
Process Forms Workflows
Sets services
Owner
Hardware


Planning for
Validation
• Validation Plans should specify:
• Scope of validation effort
• Approach (i.e. risk based)
• Resources
• Roles and responsibilities
• Activities, tasks, and deliverables

Source: GAMP5


Continuous
Improvement
Activities
• Understanding
• Considering current levels of conformance to the process
• Reviewing current processes against recognized good
practices
• Identifying areas of the system that may require
improvement.
• Metrics
• Metrics may be gathered throughout the system life cycle,
including:
• design and development metrics
• testing metrics
• operation and maintenance metrics

Source: GAMP5

What are the
challenges?
Concept

• Correctly measuring business
processes and business risks
• Identifying what regulations apply to a
system
• Identifying existing functionality that
can be leveraged to reduce effort to
implement a new system


What are the
challenges?
Project

• Following a standardized
implementation & validation process
that is consistent across all systems
• Producing documentation according to
standard procedures and templates
• Tracking deliverables and overall
project status
• Managing document review and
approval cycles


Project

CSV Process &
Deliverables
Relationship between CSV Deliverables
Perform Validation Plan / Determine Develop test protocols &
Identify requirements Develop Specifications
Assessment Risk scripts

Validation
Validation Plan Test Protocol(s)
Assessment

Functional
Risk Assessment Test Script
Specification
Inventory

Specification(s) Configuration
Specification
Requirement(s)
EXECUTE
Test Script(s)
Design Specification

Traceability
Matrix


Project

CSV Process &
Deliverables (Cont.)


What are the
challenges?
Operation

• Maintaining IT systems in a validated state
• Establishing the IT system inventory and
landscape
• Traceability between specifications and tests
• Keeping system documentation up to date
• Managing system functional & configuration
changes
• Managing logical access to regulated
systems
• Gathering metrics and understanding the
effectiveness of the current processes


Source: GAMP 5

How can we use
SharePoint to meet
the challenges?
• SharePoint Sites, Libraries & Lists:
• Document Templates for creation of standardized system
validation documentation
• Libraries & List for storage of system documents and data
• Web-based Info Path Forms for capturing user process inputs
• Dashboard for tracking of KPIs and process metrics
• Nintex Workflows
• Workflows for management of process used to achieve and
maintain control over IT systems development,
implementation and maintenance
• Adlib Express
• Generation of PDF records for Validation Documents and
forms (i.e. Change Control, Non-Conformance Reports, etc.)


What are the
benefits?
• Centralized management of all systems
documentation and validation activities
• Centralized management of system maintenance
change management activities
• Improves control and traceability of the CSV process
• Enables standardization and reuse of generic
validation deliverables
• Standardized approach minimizes time, effort and
cost
• Ability to ascertain CSV progress and validated state
in real-time
• Information is available online in one single location -
facilitates access for internal audits


Overview of
Montrium’s CSLM
Workspace


CSLM Workspace
Characteristics
• Based on GAMP5
• System Description InfoPath File enables the full
traceability of all associated:
• Functional Areas
• Components
• Hardware
• COTS
• Facilitates the evaluation of validation activities and
determines the validated state
• Workflow for Change Control to manage review &
approval, implementation & close-out


IT Change Control
Process Overview


CSLM Libraries &
Lists
• System Inventory
• System Description (i.e. System Landscape)
• System Functional Areas
• System Component List
• Hardware Inventory
• COTS Inventory
• System Documentation
• CSV Documents
• Standard User Requirements Bank(i.e. Regulatory requirements)
• Standard Test Scripts Bank
• Other System Documents
• Templates
• System Testing
• CSV Packs
• Executed Test Scripts
• NCR
• System Maintenance
• Change Requests
• SharePoint Configuration Specifications


What’s next…
• Montrium will present the fifth and final webinar in its
SharePoint for Pharma series on Going Paperless –
Executing Validation of GxP Systems Electronically
using SharePoint on Friday June 18th 2010 at 11am
EST
• This webinar will cover:
• Using integrated workspaces in SharePoint to manage validation
documents
• Using workflows to manage validation document lifecycle and test
execution
• Maintaining the validated state: Integration with change control and
configuration management
• Automating traceability through the use of standards
• Leveraging business intelligence dashboards to manage validation
projects
We look forward to seeing you there!

Contact Details
Michael Zwetkow
Montrium Inc.
361 St-Joseph West,
Montreal (QC) H2V 2P1
Canada

Tel. 514-223-9153
info@montrium.com
www.montrium.com

SharePoint for Pharma - Computer System Life Cycle Management

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