SharePoint for Pharma - Computer System Life Cycle Management

www.montrium.com COPYRIGHT MONTRIUM 2010

SharePoint for Pharma -Computer System Life Cycle Management

Presented by Michael ZwetkowPharmaceutical IT Project Leader

June 04th 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


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


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

• 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


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


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


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 GxPcomputerized systems provide summary information such as:• Validation status• Ownership• Impact (Functional Area affected)• Current system version• Supplier/Vendor

Source: GAMP5


System Inventory

System DescriptionSystem

Validation State

System Owner & Admin

COTS

Hardware

Functional Areas

CSV Pack

Process Owner

ComponentsFeature

Sets Forms Workflows Web services


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?

• 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



• 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

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


CSV Process & Deliverables (Cont.)

Project



• 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


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 ZwetkowMontrium Inc.

361 St-Joseph West,Montreal (QC) H2V 2P1

Canada

Tel. [email protected]

SharePoint for Pharma - Computer System Life Cycle Management

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