sharepoint for pharma - computer system life cycle management
DESCRIPTION
SharePoint for Pharma - Computer System Life Cycle Management Presented by Michael Zwetkow, VP Operations, Montrium Inc. For more information on Montrium please visit: - www.montrium.com - www.twitter.com/Montrium - www.youtube.com/Montrium - gplus.to/Montrium or email [email protected]TRANSCRIPT
www.montrium.com COPYRIGHT MONTRIUM 2010
SharePoint for Pharma -Computer System Life Cycle Management
Presented by Michael ZwetkowPharmaceutical IT Project Leader
June 04th 2010
www.montrium.com COPYRIGHT MONTRIUM 2010
• 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.
Recap of last webinars
2
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Webinar Overview• Introduction to the GAMP 5 Life Cycle Approach• Activities for achieving and maintaining
compliance of IT systems within a regulated GxPenvironment
• 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
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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
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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
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Life Cycle Phases and Activities
Concept
• Develop Initial Requirements
• Identify potential solutions
Project
• Planning• Supplier
assessment and selection
• Specification & Configuration
• Verification• Report &
Release
Operation
• System Maintenance
• Functional Change Management
• Configuration Change Management
Retirement
• Data Retention
• Migration• System
Withdrawal
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GAMP 5 – Systems Management
Change management & continuous improvement activities
Planning for validation
Maintaining a system inventory
Managing supplier relationships
Training
Identifying roles and responsibilities
Establishing computerized systems compliance policies and procedures
Quality Management
Life Cycle Management
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Computerized Systems Policies and Procedures
• Identify and comply with all applicable GxPrequirements
• 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
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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
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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
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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
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Maintaining the System Inventory
• Maintain an inventory of GxPcomputerized systems provide summary information such as:• Validation status• Ownership• Impact (Functional Area affected)• Current system version• Supplier/Vendor
Source: GAMP5
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System Inventory
System DescriptionSystem
Validation State
System Owner & Admin
COTS
Hardware
Functional Areas
CSV Pack
Process Owner
ComponentsFeature
Sets Forms Workflows Web services
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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
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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
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What are the challenges?
• 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
Concept
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What are the challenges?
• 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
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CSV Process & Deliverables
Relationship between CSV Deliverables
Develop test protocols & scriptsDevelop SpecificationsPerform Validation
AssessmentPlan / Determine
RiskIdentify requirements
Configuration Specification
Validation Plan
Traceability Matrix
Test Script Inventory
Design Specification
Specification(s)
Validation Assessment
Risk Assessment Functional Specification
Requirement(s)Test Script(s)
Test Protocol(s)
EXECUTE
Project
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CSV Process & Deliverables (Cont.)
Project
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What are the challenges?
• 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
Operation
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Source: GAMP 5
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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.)
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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
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Overview of Montrium’s CSLM Workspace
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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
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IT Change Control Process Overview
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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
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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!
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Contact Details
Michael ZwetkowMontrium Inc.
361 St-Joseph West,Montreal (QC) H2V 2P1
Canada
Tel. [email protected]