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1 Manage Software Development, Testing, and Validation Presented by Sharon Strause, Senior Consultant EduQuest, Inc. IVT s Computer and Software Validation EU Conference The Hilton Dublin Dublin, Ireland September 27 29, 2010 Sharon Strause 15 years with the Pharmaceutical industry Documentation Computer System Validation Quality Assurance in information management. 6 years consulting LifeScience Industries Consumer Product Industries Software Development Companies September 29, 2010 Copyright EduQuest, Inc. 2 1
2 Where are you from? September 29, 2010 Copyright EduQuest, Inc. 3 SDLC Software Development Life Cycle Custom Software Procedures Requirements Testing Integration Maintenance/Change control System Development Life Cycle Custom software completed and ready for integration system. September 29, 2010 Copyright EduQuest, Inc. 4 2
3 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc. 5 Benefits -In-House Development Defined policies, SOPs, & guidelines Accountability to Senior Management Resources and budget Knowledge of business Personnel are available Team approach September 29, 2010 Copyright EduQuest, Inc. 6 3
4 Drawbacks -In-House Development Limited Resources No technical expertise Non-efficient use of resources Long-term maintenance September 29, 2010 Copyright EduQuest, Inc. 7 Company Concerns With Vendors Determining that qualified development resources are available Understanding of the project Ability to work independently Delivery of a functioning system within time and budget Meeting internal QA standards Final accountability level September 29, 2010 Copyright EduQuest, Inc. 8 4
5 Benefits - Vendor Development Availability of internal resources Availability of technical matter experts Experience Multiple implementation approaches What they do best Unlimited resources available September 29, 2010 Copyright EduQuest, Inc. 9 Drawbacks - Vendor Development Not accountable to Company management Delays when questions require answering General knowledge of Company operations Conflicts between Company procedures and Vendor procedures Budget & resources may be fixed We vs. Them approach to project Team approach not evident September 29, 2010 Copyright EduQuest, Inc. 10 5
6 Vendor s Concerns Project Completing on time Project efficiency Who s coordinating the plan Keeping work in the pipeline Adhering to Company procedures/sops Multiple clients Ability to service all Flexibility to meet different standards and needs September 29, 2010 Copyright EduQuest, Inc. 11 Finding a Qualified Vendor First: Check within your own company Second: Check other affiliate organizations Third: Industry networking resources Industry yp publications and journals Fourth: Other Vendor recommendations September 29, 2010 Copyright EduQuest, Inc. 12 6
7 Selecting a Vendor Previous Vendor Good experience Vendor known in your industry Benchmark their work Audit the vendor September 29, 2010 Copyright EduQuest, Inc. 13 Pre-Selection Audits In-Process Audits When to Audit... Post-Development Audits September 29, 2010 Copyright EduQuest, Inc. 14 7
8 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc. 15 Planning If you don t know where you are going, you are likely to end up someplace else! Lewis Carroll September 29, 2010 Copyright EduQuest, Inc. 16 8
9 Planning Basic Elements Problem Definition - Quote: 80% of projects that fail do so at the outset because they have not been defined properly James Lewis Helps define your solution/option suite Assists project team with scope control. September 29, 2010 Copyright EduQuest, Inc. 17 Quote: Planning Basic Elements Those who fail to plan, plan to fail.fda Common Characteristic of unsuccessful projects Conducted in secret Project plans Planned by the people who will use them to complete the project September 29, 2010 Copyright EduQuest, Inc. 18 9
10 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc. 19 Don t Plan to Fail (1) Project management Key to SDLC Stage Gates Concept Early Planning Project Initiation Definition Requirements Solution Analysis Quality Review September 29, 2010 Copyright EduQuest, Inc
11 Don t Plan to Fail (2) Stage Gates (Continued) Construction Detailed Design Assemble/Test Quality Review Implementation Preparation Warranty Quality Review Benefit Quality Review Sustain the Pipeline Quality Review September 29, 2010 Copyright EduQuest, Inc. 21 Identifying Stakeholders A person or organization (e.g. customer, sponsor, performing organization, or the public) that is actively involved in the project, or whose interest may be positively or negatively affected by the execution or completion of the project. A stakeholder may also exert influence over the project and its deliverables. September 29, 2010 Copyright EduQuest, Inc
12 Management User Community Project Team Technical Team Power Users Support Team Key Stakeholders September 29, 2010 Copyright EduQuest, Inc. 23 Controlling Computer System Software Hardware Controlled Process Equipment Operating Procedures and Documentation People Total Computerized System September 29, 2010 Copyright EduQuest, Inc
13 What needs to be validated? Software 1 Hardware 2 Equipment 4 Controlling System (Computer System) 3 Operating Procedures and Documentation 5 Total System (Computerized System) 7 Operational Environment 8 Controlled Process 6... and all the links between the boxes September 29, 2010 Copyright EduQuest, Inc. 25 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc
14 Quality Process in place includes. SDLC Methodology Design Standards Project Planning Programming Standards Personnel Qualifications Configuration Documentation Management Standards & Procedures Testing Standards & Methods for review & Procedures approval Separation of Development, Test and Production Environments September 29, 2010 Copyright EduQuest, Inc. 27 Quality Process in place includes. Move to Production Change Management Process Training process Clearly defined Process for continuous responsibilities evaluation, incident Involvement of: monitoring, error correction Customer/User Processes and procedures for Quality Assurance physical & logical security of professionals system and data Technology Professionals September 29, 2010 Copyright EduQuest, Inc
15 System Development Life Cycle Retirement Recommendation Project Initiation P E R A O Aging Conceptualization Development Release for Use T I Maturity Early Operational Life l O N A L L I F E September 29, 2010 Copyright EduQuest, Inc. 29 Example Systems Development Life Cycle System Development Life Cycle Concept Phase Requirements Phase Design Phase Implementation Phase Integration Phase Installation Phase Maintenance Phase Feasibility Study Report - Project Scope - Risk/Safety Analysis - Process Desc. and PIDs - Technology Assessment - Regulatory Assessment Training Requirements Management Approval Appropriation Approval TPM Review Detail Project Plan Project Plan for Remaining Phases Validation Plan Vendor Quality Management Plan Vendor Qualification Report Risk/Safety Analysis Requirements Specifications Functional Specifications Training Plan User/Tech/Train Manuals Plan Test Plan TPM Review Bus Tech Risk ID Project Plan Approvals Risk/Safety Analysis Requirements Specification Functional Specifications System Design Specifications Traceability Matrix In-Process Audit Report Requirements Specifications Functional Specifications System Design Specifications Traceability Matrix Requirements Specifications Functional Specifications System Design Specifications Traceability Matrix Source Code Executable Code IQ, OQ, PQ Reports Periodic Review Traceability Matrix Report User/Technical Manuals Change Request/ Training Materials Implementation Reports Disaster Recovery Document Supplements Plan Maintain Training Vendor Quality System Retirement Management Plan Approvals Validation Report Test Plan Development Test Training Materials Production Installation Development Test Plan User/Tech/Train Turnover Plan Plan IQ, OQ and PQ Manuals Post Implementation Factory Acceptance FAT Plan FAT Documents/ Plan Test (FAT) Source Code Reports Approvals IQ, OQ and PQ Executable Code IQ, OQ, PQ Protocols Training Plan Code Review Integration Test User/Tech/Train Documents Documents Manuals Test Execution Approvals Conversion Plan Documents NOTE: TPM Review Training Plan/Materials - Documentation deliverables may be developed during Approvals User/Tech/Train Manuals one phase of the life cycle and updated in one or more Acceptance/Implementation subsequent phases. September 29, 2010 Copyright Plan EduQuest, Inc. Approvals 2010 EduQuest, Inc
16 Identifying Validation Dependencies Network qualification Servers Lines, Routers, etc. Data Migration Interfaces Data Migration as well as ongoing use interfaces Schedules from other groups Implementation i.e. Inventory completed Marketing Launch schedule Other support personnel Testing personnel Training personnel September 29, 2010 Copyright EduQuest, Inc. 31 Data Migration Migration Process Planned Defined Documented Cleansing Formatting Conversion Testing Production Testing Statistical Analysis September 29, 2010 Copyright EduQuest, Inc
17 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc. 33 Requirements Requirements are the foundation for your implementation ti and validation efforts. Requirements are the most critical aspect of your implementation for they will determine all aspects of the project from timeline to infrastructure to validation to testing to maintenance!! September 29, 2010 Copyright EduQuest, Inc
18 Requirements The cost to fix an error is generally 200 times more expensive in work or resources as compared to fixing it before implementation. Requirement errors account for 40-60% of defects in software. Requirements engineering is where the informal meets the formal Requirements should be detailed enough so that designers know what to build and those developing the tests know what to test. September 29, 2010 Copyright EduQuest, Inc. 35 How Long Does It Take To Develop Requirements? One study revealed that for the successful projects, 28% of the project resources were spent on requirements. Furthermore 38% of the schedule went to requirements. NASA projects that spent more than 10% of their total resources in the requirements phase, finished sooner and had lower costs compared to those that did not. European study indicated that faster projects dedicated 14% of their efforts on requirements and 17% of the schedule, as compared to slower projects only committing 7% of their efforts and 9% of the schedule. Results from summaries in Software Requirements by Karl Wiegers. September 29, 2010 Copyright EduQuest, Inc
19 Basic Requirement Categories Essential If these are not met then the system will not be accepted. Core functionality, security, regulatory compliance, etc. Desired (but not essential) Having these would be great and may even have a large impact on the process being automated, but are not essential to the success of the project. Process improvements, personal preferences, etc. September 29, 2010 Copyright EduQuest, Inc. 37 Levels of Requirements Business process High level objectives for the business process being automated User What the user will be able to do with the system (typically focused on system/user interactions) Functional Specific behaviors the system must exhibit Non-functional External interfaces, design constraints, quality attributes, implementation constraints, etc. September 29, 2010 Copyright EduQuest, Inc
20 Requirements Characteristics of good requirements Complete Consistent Necessary Accurate Testable/Verifiable Traceable Unambiguous Valid September 29, 2010 Copyright EduQuest, Inc. 39 How to Gather Requirements Group effort All key stakeholders involved/represented Diagram current and proposed process Case studies Workshops Questionnaires September 29, 2010 Copyright EduQuest, Inc
21 Managing Requirements Develop a numbering scheme AT-1 AT-2 AT-2.1 AT-2.2 SEC-1 Requirement development is a group effort with stakeholder involvement Requirements should be approved and changes managed Change management process should be formal Changes are okay if they are controlled Change can affect scope, pending work, completed work, timeline, cost, etc. September 29, 2010 Copyright EduQuest, Inc. 41 Completing Requirements When are you done? Can t think of any more requirements within the scope of the project New use cases are just another alternative to derive requirements that have already been captured. Stakeholders start to repeat issues previously discussed A gap analysis of the areas that needed to be addressed shows all concerns are documented. September 29, 2010 Copyright EduQuest, Inc
22 Completing Requirements Inspect the requirements for the attributes they are supposed to possess Inspect the requirements for the attributes they are not supposed to possess such as design details, implementation details, project deadlines Checklists are often helpful September 29, 2010 Copyright EduQuest, Inc. 43 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc
23 GAMP Tools for Evaluation Lifecycle approach Phased to Project Management and Validation Process FMEA Quality Tools Six Sigma September 29, 2010 Copyright EduQuest, Inc. 45 Can Documentation Add Risk? Do not document for documentation sake (i.e. to make the validation stack bigger and weigh more) Improperly implemented documentation can add risk to your project Poor requirements Blanket procedures that apply to all situations without regard to risk Lack of key documentation Make your documentation meaningful and every word count September 29, 2010 Copyright EduQuest, Inc
24 Feasibility Stage User Requirements Specification Response to User Requirements Specification R Is Validation Required? Yes Determine Scope of Validation No Decision Documented Supplier Assessment and Purchase R Document Justification of Validation Approach Functional Spec and Design R Update Validation Plan Test System Validated System R Develop elop Test Plans Risk Assessment and Validation Process, GAMP 4 Change Control R September 29, 2010 Copyright EduQuest, Inc. 47 Project Implementation Activities Validation Activities Risk Management Risk Analysis Risk Evaluation Risk Mitigation/Control Identify the system Identify hazards and possible harms Estimate, justify and document risk level (probability/severity) Estimate costs of mitigation vs. non-mitigation Define and take actions for mitigation Risk asse essment On-going Evaluation Monitor for new harms Monitor risk levels Update plan and take actions September 29, 2010 Copyright EduQuest, Inc
25 Risk Assessment Start with a Process Flow Chart Determine potential risks of the process relative to intended use List critical control points for each identified hazard List critical limits for each of the critical control points List procedures used to monitor each of the critical control points September 29, 2010 Copyright EduQuest, Inc. 49 Custom Development In-House Vendor Planning Project Methodology Quality Process Requirements Risk Management Testing Agenda September 29, 2010 Copyright EduQuest, Inc
26 Test Scripts Test scripts provide documented evidence that you have tested the system against your requirements. The scripts may be called for to demonstrate your overall validation efforts or to demonstrate that a specific function is performing as anticipated. September 29, 2010 Copyright EduQuest, Inc. 51 Are All Test Scripts the Same? No - test scripts may be designed to fit the type of qualification testing but can contain similarities They should be traceable Vendor s or developer s specifications (equipment, environmental, etc.) (IQ) Functional requirements (OQ) Routine business process(es) (PQ) September 29, 2010 Copyright EduQuest, Inc
27 Approach Where do you begin? September 29, 2010 Copyright EduQuest, Inc. 53 IFYOUW OULDJUS TTELLMEW HATTODOTH ENIWOULDNOTH AVE TOTHINKATALL September 29, 2010 Copyright EduQuest, Inc
28 Right Things in Focus Understanding the principles Knowing the requirements Knowing the governing regulations Establishing the risk Detailed application Becomes a matter of rational trial and error Document, Document, Document Don t take shortcuts Do Lessons Learned Evaluate, Evaluate, Evaluate September 29, 2010 Copyright EduQuest, Inc. 55 Q U E S T I O N S September 29, 2010 Copyright EduQuest, Inc
29 Thank You September 29, 2010 Copyright EduQuest, Inc
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