SDLC Methodologies and Validation
|
|
- Melina Dorsey
- 8 years ago
- Views:
Transcription
1 SDLC Methodologies and Validation Presented by: Pamela Campbell Lead Consultant, Compliance Services DataCeutics, Inc. Presented for: DIA Annual Meeting, June 2004 Session 330 VA Validation, EDM, IT June 16, :30am
2 Who We Are. The Leader in Information Technology Support and Services for the Clinical Research Environment Headquartered in Pottstown, PA Solutions include Services and Software Products Three Business Lines: Clinical Systems Services (CSS) Clinical Reporting Services (CRS) Computer Systems Compliance Services (CSCS) Expert Consultants
3 Our Computer Systems Compliance Philosophy... Computer Systems must be planned, designed, developed, tested, installed, operated, maintained, and archived according to regulations and acceptable industry and company standards
4 Agenda Validation The Phases of a Project Project Conception System Study Programming Acceptance Operational Maintenance Decommission Conclusions
5 Validation Validation The establishing of documented evidence through defined tests & challenges, that a system or process meets design criteria & that adequate provisions have been established to keep it in a state of control so it will produce a product that meets predetermined specifications and quality attributes. When done correctly validation creates sustainable, repeatable success! When done incorrectly validation becomes a burden that hinders business and results in audit findings and Form 483s.
6 Phases of a Project Project Management Conception Define Scope SDLC Validation Plan Validation System Study (Design) Programming Acceptance Operational Maintenance User / Function Requirements Design Code Unit Testing System and Integration Performance and User Acceptance Testing Installation Release User / Function Requirements Specification System Design Specification Vendor and Risk Assessments Code Reviews Unit Test Plan, Scripts, Matrix, Report System and Integration Plan, Scripts, Matrix, Report PQ/UAT Test Plan, Scripts, Matrix, Report IQ/OQ Plan, Execution, IQ/OQ Report, Validation Report Change Control, Backup Functioning under SOPs for change and Recovery, Archiving control, etc.
7 Project Conception Critical function definition of scope Both the project scope and the scope of the validation must be defined in this phase! Both should be defined in the validation plan. Scope creep will kill a project! Determine what is not covered by the project, examples: Network qualification Data Center qualification
8 System Study Chosen methodology for designing system should be spelled out in a SDLC SOP or the validation plan. Validation and project deliverables: User & Functional Requirement Specifications Remember requirements must be testable! Don t forget 21 CFR Part 11 & Predicate Rules! System Design Specification edms purchased system describe how the system is to be installed, configured, and programmed Matrix from UFRS to Design For Vendor systems Vendor Assessment! Risk Assessment
9 Development Methodologies (System Study) Waterfall Whirlpools Incremental / Spiral Prototyping Whichever is selected it must be documented in the validation plan and any matching SOPs!
10 Waterfall Conception Requirements Design Programming Code Review Unit Test SIT UAT Installation Operation Maintenance
11 Waterfall - issues Studies show waterfall method is 90% project management and 10% what is to be done and how to do it. Each phase feeds into the next and therefore there is no feedback creating a gap between end user and developers. No way to go back and fix mistakes. Very expensive to use. Takes a long time.
12 Whirlpool Conception Initial Iteration Conception Requirements Design Programming Code Review Unit Test SIT UAT Installation Operation Verification Loop Reconcile system to expectations Maintenance
13 Whirlpool Basics More interaction between initiators and staff implementing requirements. Verification Loop second iteration to remove bugs found in testing. Loop to reconcile system to user expectations was the correct system built? Steps move and shift to save time and money when answering this question.
14 Whirlpool Difficulties Very complex methodology. Difficult to manage due to number of iterations. Hand off to maintenance tends to be shaky. Still gaps between - What and How Developers present system instead of users presenting requirements.
15 Incremental / Spiral Conception Reconciliation Requirements Requirements Reconciliation Reconciliation Design Requirements Design Verification Reconciliation Programming Verification Design Code Review Programming Unit Test Verification Code Integration Review Unit Test Programming Integration SIT Code Review Unit Test UAT SIT Integration UAT Installation SIT Operations Installation& UAT Maintenance Operations & Reconciliation Maintenance Installation Reconciliation Operations & Maintenance Reconciliation
16 Incremental / Spiral Perform the waterfall in sections. Several mini projects are undertaken to implement the goal. Gap between what and how is narrowed. Requirements and Design are closely related. Clean Interfaces must be maintained between the modules.
17 Prototyping Conception Requirements Design Programming Code Review Prototyping Each phase feed into the next, But there is feedback among the first three phases Unit Test SIT UAT Installation Operation Maintenance
18 Prototyping Prototyping is a process that permits the developer to create a model or mock-up of the system to be built. It must be decided in advance if the prototype is a throwaway or to be kept as the initial version of the system. If the prototype is the initial version of the system the code must be placed under configuration management. The choice must be documented in the validation plan.
19 Prototyping Prototyping begins with some type of protosystem or model. Then an initial set of requirements is created. The model is then updated with modifications. A matching update of the requirements is made. This process is repeated until the requirements are finalized.
20 Prototyping Issues Keeping code under control. Customer does not realize the prototype is not a working supportable code model and does not understand additional time required to go from prototype to deliverable system. An inappropriate operating system or programming language may have been used to create the model and everything must be reworked. Rules must be defined before prototyping begins! Validation Plan Prototyping SOP
21 Programming Validation and Project Deliverables Code Code walk throughs Memos Responses Unit Testing Plan (Matrix from UFRS to Design to Scripts) Scripts Report of results (include resolutions to errors) System and Integration testing Plan (Matrix from UFRS to Design to Scripts) Scripts Report of results (include resolutions to errors)
22 Programming Code should be written in a controlled manner. Standards help promote the writing of maintainable code. Code / configuration management Permits the easy backing out of changes. Allows for repeatability. Metrics. Code walk throughs! Verify standards are being followed. Match code to what is being stored and tracked in Code Management tools.
23 Programming Unit Testing Test the individual modules. Do the requirements track to a module or will an SOP need to be written to meet a requirement? Users should be told as soon as possible. System and Integration Testing When modules interface with each other and the target Operating System do they continue to work? Again do requirements track?
24 Acceptance Validation and Project Deliverables IQ/OQ for testing Installation and Operation Qualification for Test System Execution Report of Results Performance Qualification / User Acceptance Testing Plan Scripts Execution of scripts Resolution of non-conformances Traceability Matrix Report of results
25 Acceptance Performance Testing This is only useful if performance requirements were defined so that they are measurable. Internet speed can not be meaningfully tested! No one company has end to end control of an Internet connection. Performance testing should be executed on manufacturing systems and laboratory systems that function in real-time! Other items such as scanners for edms may also require testing for data transfer tolerances.
26 Acceptance User Acceptance Testing Scripts should mimic actual plan use of the system. If instruments or devices will be connected and transferring data, check those interfaces! Remember to do all those security tests for 21 CFR Part 11! This is critical for edms that will use electronic signatures. If a SOP will be used for missing functionality make sure this is documented in the PQ/UAT Traceability Matrix and PQ/UAT Report.
27 Operational Validation and Project Deliverables Installation and Operation Qualification for Production System Test items such as backup and physical security if not tested in PQ/UAT Execution Report of Results Validation Report Deviations from the Validation Plan Any non-conformances from testing - include resolution
28 Maintenance The system is now in a controlled, successfully functioning state, how will you keep it there? SOPs Change Control Validation and Re-validation Security Anti-Virus Disaster Recovery Business Continuity User Management Auditing
29 Decommission When the system becomes obsolete, how will the data from it be stored to match the data retention policy? Migrate information to another system? Mothball the system? Retire the system but keep it running?
30 Other things to worry about... Security Do your backups really work? Test them! Disaster Recovery (did you test that plan?) Network Qualification Data Center Qualification Training in the new application On going training for new hires
31 Training Make sure your developers data center staff receives validation training! Also help your staff understand the end product that actually brings in the money that pays their salary. Give them a reason to take pride in the validation and compliance process.
32 Conclusions and Summary Validation need not be a burden. Incorporate it into daily operations! Results Functioning systems Supportable systems Repeatable performance Improved business processes Fewer audit findings!
33 References DeGrace, P. & Stahl, L. H. (1990). Wicked Problems, Righteous Solutions: A Catalogue of Modern Software Engineering Paradigms. Englewood Cliffs, NJ: Yourdon Press Computing Series. Pressman, R. S., (1993). A Manager s Guide to Software Engineering. New York: McGraw- Hill. The Validation Dictionary. Royal Palm Beach, FL: Institute of Validation Technology.
Computerised Systems. Seeing the Wood from the Trees
Computerised Systems Seeing the Wood from the Trees Scope WHAT IS A COMPUTERISED SYSTEM? WHY DO WE NEED VALIDATED SYSTEMS? WHAT NEEDS VALIDATING? HOW DO WE PERFORM CSV? WHO DOES WHAT? IT S VALIDATED -
More informationComputer System Validation for Clinical Trials:
Computer System Validation for Clinical Trials: Framework Standard Operating Procedure (F-SOP) Author: Tim Cross Version History: 0.1di DRAFT 24-April-2013 0.2 DRAFT 12-June-2013 Current Version: 1.0 17-June-2013
More informationCONTENTS. List of Tables List of Figures
Prelims 13/3/06 9:11 pm Page iii CONTENTS List of Tables List of Figures ix xi 1 Introduction 1 1.1 The Need for Guidance on ERP System Validation 1 1.2 The Need to Validate ERP Systems 3 1.3 The ERP Implementation
More informationThe Software Development Life Cycle (SDLC)
Document ID: Version: 2.0 1 / 22 2 TABLE OF CONTENTS INTRODUCTION... 4 THE SDLC WATERFALL... 4 ALLOWED VARIATIONS... 5 OTHER SDLC MODELS... 6 REFERENCES... 7 GENERIC STAGE... 8 KICKOFF PROCESS... 8 INFORMAL
More informationValidating Enterprise Systems: A Practical Guide
Table of Contents Validating Enterprise Systems: A Practical Guide Foreword 1 Introduction The Need for Guidance on Compliant Enterprise Systems What is an Enterprise System The Need to Validate Enterprise
More information074-8432-552 Page 1 of 7 Effective Date: 12/18/03 Software Supplier Process Requirements
Page 1 of 7 Software Supplier Process Requirements 1.0 QUALITY SYSTEM FRAMEWORK 1.1 QUALITY POLICY The Seller shall document and implement a quality program in the form of Quality manual or detailed Quality
More informationHow To Write An Slcm Project Plan
SLCM 2003.1 Artifacts in a Nutshell ( as of 01/21/2005) Project Development Phases Pension Benefit Guaranty Corporation s (PBGC) System Life Cycle Methodology (SLCM) is comprised of five project development
More informationProject Risk and Pre/Post Implementation Reviews
Project Risk and Pre/Post Implementation Reviews Material Changes to the System of Internal Control VGFOA Conference (Virginia Beach, VA) May 20, 2015 Agenda/Objectives Understand why system implementations
More informationComputerized System Audits In A GCP Pharmaceutical Laboratory Environment
IVTGXP_july06.qxd 6/28/06 1:09 PM Page 36 Computerized System Audits In A GCP Pharmaceutical Laboratory Environment By Maintaining data integrity for both clinical laboratory processes and patient data
More informationUnit I. Introduction
Unit I Introduction Product Life Cycles Products also have life cycles The Systems Development Life Cycle (SDLC) is a framework for describing the phases involved in developing and maintaining information
More informationInternational Journal of Advance Research in Computer Science and Management Studies
Volume 2, Issue 12, December 2014 ISSN: 2321 7782 (Online) International Journal of Advance Research in Computer Science and Management Studies Research Article / Survey Paper / Case Study Available online
More informationServices Providers. Ivan Soto
SOP s for Managing Application Services Providers Ivan Soto Learning Objectives At the end of this session we will have covered: Types of Managed Services Outsourcing process Quality expectations for Managed
More informationInstallation and Operational Qualification Protocol (Reference: SOP )
Project Name Equipment Process Line/Location Project Number Serial Number Model Number Protocol number WRITTEN BY: REVIEWED BY: Position APPROVAL TO EXECUTE: Position: PROTOCOL COMPLETION APPROVAL: Position:
More informationComputer System Validation - It s More Than Just Testing
Computer System Validation - It s More Than Just Testing Introduction Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application
More informationTesting Automated Manufacturing Processes
Testing Automated Manufacturing Processes (PLC based architecture) 1 ❶ Introduction. ❷ Regulations. ❸ CSV Automated Manufacturing Systems. ❹ PLCs Validation Methodology / Approach. ❺ Testing. ❻ Controls
More informationIntroduction to Cloud Computing What is SaaS? Conventional vs. SaaS Methodologies Validation Requirements Change Management Q&A
Best Practices for Validation of a Software as a Service (SaaS) Customer Relationship Management (CRM) Solution Presented By: Gregg Mauriello Validation Manager Elise Miner Associate Validation Manager
More informationYour Software Quality is Our Business. INDEPENDENT VERIFICATION AND VALIDATION (IV&V) WHITE PAPER Prepared by Adnet, Inc.
INDEPENDENT VERIFICATION AND VALIDATION (IV&V) WHITE PAPER Prepared by Adnet, Inc. February 2013 1 Executive Summary Adnet is pleased to provide this white paper, describing our approach to performing
More informationPHASE 6: DEVELOPMENT PHASE
PHASE 6: DEVELOPMENT PHASE The Phase features a key step in the project: system construction. The previous phases lay the foundation for system development; the following phases ensure that the product
More informationTemplate K Implementation Requirements Instructions for RFP Response RFP #
Template K Implementation Requirements Instructions for RFP Response Table of Contents 1.0 Project Management Approach... 3 1.1 Program and Project Management... 3 1.2 Change Management Plan... 3 1.3 Relationship
More informationPHASE 8: IMPLEMENTATION PHASE
PHASE 8: IMPLEMENTATION PHASE The Implementation Phase has one key activity: deploying the new system in its target environment. Supporting actions include training end-users and preparing to turn the
More informationRe: RFP # 08-X-39202 MOTOR VEHICLE AUTOMATED TRANSACTION SYSTEM (MATRX) FOR MVC ADDENDUM #10
State of New Jersey DEPARTMENT OF THE TREASURY JON S. CORZINE DIVISION OF PURCHASE AND PROPERTY BRADLEY I. ABELOW Governor PURCHASE BUREAU State Treasurer P.O. BOX 230 TRENTON, NEW JERSEY 08625-0230 September
More informationImplementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.
Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title
More informationPHASE 9: OPERATIONS AND MAINTENANCE PHASE
PHASE 9: OPERATIONS AND MAINTENANCE PHASE During the Operations and Maintenance Phase, the information system s availability and performance in executing the work for which it was designed is maintained.
More informationConsiderations When Validating Your Analyst Software Per GAMP 5
WHITE PAPER Analyst Software Validation Service Considerations When Validating Your Analyst Software Per GAMP 5 Blair C. James, Stacy D. Nelson Introduction The purpose of this white paper is to assist
More informationOverview of STS Consulting s IV&V Methodology
Overview of STS Consulting s IV&V Methodology STS uses a 5 Step Methodology for IV&V. Our risk-based methodology conforms to Best Practices, relevant international standards, and regulations/guidelines
More informationInformation Technology Policy
Information Technology Policy Systems Development Life Cycle Policy ITP Number ITP-APP012 Category Recommended Policy Contact RA-itcentral@pa.gov Effective Date May 1, 2013 Supersedes Scheduled Review
More informationIndependent Verification and Validation of SAPHIRE 8 Software Project Plan
INL/EXT-09-17022 Rev. 2 Independent Verification and Validation of SAPHIRE 8 Software Project Plan March 2010 The INL is a U.S. Department of Energy National Laboratory operated by Battelle Energy Alliance
More informationThe SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies
The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies The SaaS LMS and Total Cost of Ownership in FDA-Regulated Companies By Rob Sims, Director, Life Science, UL EduNeering When a Life Science
More informationTIBCO Spotfire and S+ Product Family
TIBCO Spotfire and S+ Product Family Compliance with 21 CFR Part 11, GxP and Related Software Validation Issues The Code of Federal Regulations Title 21 Part 11 is a significant regulatory requirement
More informationCS 389 Software Engineering. Lecture 2 Chapter 2 Software Processes. Adapted from: Chap 1. Sommerville 9 th ed. Chap 1. Pressman 6 th ed.
CS 389 Software Engineering Lecture 2 Chapter 2 Software Processes Adapted from: Chap 1. Sommerville 9 th ed. Chap 1. Pressman 6 th ed. Topics covered Software process models Process activities Coping
More informationCDC UNIFIED PROCESS JOB AID
CDC UNIFIED PROCESS JOB AID Independent Verification & Validation Activities Document Purpose This Job Aid is a brief document listing the items to be noted, checked, remembered, and delivered when completing
More informationSTS Federal Government Consulting Practice IV&V Offering
STS Federal Government Consulting Practice IV&V Offering WBE Certified GSA Contract GS-35F-0108T For information Please contact: gsa70@stsv.com 2007 by STS, Inc. Outline Background on STS What is IV&V?
More informationSoftware Engineering Introduction & Background. Complaints. General Problems. Department of Computer Science Kent State University
Software Engineering Introduction & Background Department of Computer Science Kent State University Complaints Software production is often done by amateurs Software development is done by tinkering or
More informationChapter 8 Approaches to System Development
Systems Analysis and Design in a Changing World, sixth edition 8-1 Chapter 8 Approaches to System Development Table of Contents Chapter Overview Learning Objectives Notes on Opening Case and EOC Cases
More informationEssentials of the Quality Assurance Practice Principles of Testing Test Documentation Techniques. Target Audience: Prerequisites:
Curriculum Certified Software Tester (CST) Common Body of Knowledge Control Procedures Problem Resolution Reports Requirements Test Builds Test Cases Test Execution Test Plans Test Planning Testing Concepts
More informationConfiguration and Asset Management
IT Product Life Cycle Management 43 Chapter 4 Configuration and Asset Management Configuration management is the process of monitoring and reviewing approved product configurations periodically while the
More informationCLINICAL DATA MANAGEMENT
J * Edition Practical Guide to CLINICAL DATA MANAGEMENT Susanne Prokscha (g) CRC Press Taylor Francis Croup London York CRC Press is an imprint of the Taylor Francis Croup, an buslness Preface Introduction
More informationComputer and Software Validation Volume II
Table of Contents Maintaining the Validated State in Computer Systems Orlando Lopez Use Automated Testing Tools? Janis V. Olson Considerations for Validation of Manufacturing Execution Systems Chris Wubbolt
More informationPHASE 5: DESIGN PHASE
PHASE 5: DESIGN PHASE During the Design Phase, the system is designed to satisfy the requirements identified in the previous phases. The requirements identified in the Requirements Analysis Phase are transformed
More informationWhen printed the document is for reference only and is considered uncontrolled - refer to the Document Control System for the most current version
QM-1 SUPPLEMENT QUALITY MANAGEMENT SYSTEMS MANUAL Revision 6 Page: 1 of 6 APPROVED BY: TITLE DATE Electronic Signature on file Quality Director 10/3/15 D. Picciotti Page: 2 of 6 DOCUMENT REVISION HISTORY
More informationunless the manufacturer upgrades the firmware, whereas the effort is repeated.
Software Validation in Accredited Laboratories A Practical Guide Gregory D. Gogates Fasor Inc., 3101 Skippack Pike, Lansdale, Pennsylvania 19446-5864 USA g.gogates@ieee.org www.fasor.com Abstract Software
More informationWelcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014
Welcome Computer System Validation Training Delivered to FDA ISPE Boston Area Chapter February 20, 2014 1 Background Training Conducted on April 24, 2012 Food & Drug Administration Division of Manufacturing
More informationControl No: QQM-02 Title: Quality Management Systems Manual Revision 10 07/08/2010 ISO 9001:2008 Page: 1 of 22
ISO 9001:2008 Page: 1 of 22 Central Technologies has developed a Quality Management System, and the associated procedures and work instructions, to be compliant to ISO 9001:2008. Utilizing this Quality
More informationAttachment 7 Requirements Traceability Matrix (RTM) ATMS RFP. New York State Department of Transportation Advanced Traffic Management System
Attachment 7 Requirements Traceability Matrix (RTM) ATMS RFP New York State Department of Transportation Advanced Traffic Management System i 1. INTRODUCTION This Requirements Traceability Matrix (RTM)
More informationRTP s NUCLEAR QUALITY ASSURANCE PROGRAM
RTP s NUCLEAR QUALITY ASSURANCE PROGRAM RTP operates under one quality program, whether you purchase products that are commercial grade, nuclear safety-related or industrial safety compliant (IEC 61508).
More informationRisk-Based Validation of Computer Systems Used In FDA-Regulated Activities
September 2, 2003 Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities Purpose This document provides a summary of the requirements relating to use of computer-based systems in activities
More informationCORPORATE QUALITY MANUAL
Corporate Quality Manual Preface The following Corporate Quality Manual is written within the framework of ISO 9001:2008 Quality System by the employees of CyberOptics. CyberOptics recognizes the importance
More informationDomain 1 The Process of Auditing Information Systems
Certified Information Systems Auditor (CISA ) Certification Course Description Our 5-day ISACA Certified Information Systems Auditor (CISA) training course equips information professionals with the knowledge
More informationIT General Controls Domain COBIT Domain Control Objective Control Activity Test Plan Test of Controls Results
Acquire or develop application systems software Controls provide reasonable assurance that application and system software is acquired or developed that effectively supports financial reporting requirements.
More informationMontana Department of Transportation Information Services Division. System Development Life Cycle (SDLC) Guide
Montana Department of Transportation Information Services Division System Development Life Cycle (SDLC) Guide Version 2 August 2, 2007 \mdt_sdlc_process\mdt_sdlc_v02.doc Table of Contents 1 Business Analysis...3
More informationOverview of how to test a. Business Continuity Plan
Overview of how to test a Business Continuity Plan Prepared by: Thomas Bronack Phone: (718) 591-5553 Email: bronackt@dcag.com BRP/DRP Test Plan Creation and Exercise Page: 1 Table of Contents BCP/DRP Test
More informationU. S. Department of Energy Consolidated Audit Program Checklist 5 Laboratory Information Management Systems Electronic Data Management
U. S. Department of Energy Consolidated Audit Program Checklist 5 Laboratory Information Management Systems Electronic Data Management Revision 4.0 February 2014 Use of this DOECAP checklist is authorized
More informationA Systems Implementation Project Planning Guide. Solutions & Project Management Services for Systems & Operations Projects
A Systems Implementation Project Planning Guide Solutions & Project Management Services for Systems & Operations Projects Business Requirements Analysis Overview Project Plan High-Level Detailed Design
More informationCamar Aircraft Products Co. QUALITY MANUAL Revision D
QUALITY MANUAL Revision D Gujll'y Manual Introduction The purpose of this manual is to describe the Quality Assurance Program implemented by Camar Aircraft Products Co. (hereafter referred to as C.A.P.C.)
More informationABSTRACT INTRODUCTION WINDOWS SERVER VS WINDOWS WORKSTATION. Paper FC02
ABSTRACT Paper FC02 Implementing SAS using Microsoft Windows Server and Remote Desktop Paul Gilbert, DataCeutics, Inc., Pottstown, PA Steve Light, DataCeutics, Inc., Pottstown, PA DataCeutics provides
More informationClinical database/ecrf validation: effective processes and procedures
TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized
More informationQUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents
Chapter j 38 Self Assessment 729 QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality
More information4.13 System Testing. Section 4 Bidder's Products, Methodology, and Approach to the Project. 4.14 System Training
Section 4 Bidder's Products, Methodology, and Approach to the Project 4.1 FACTS II Requirements Summary 4.11 Interfaces 4.2 Functional Requirements 4.12 System Development 4.3 Technical Requirements 4.13
More informationISO 9001:2008 Audit Checklist
g GE Power & Water ISO 9001:2008 Audit Checklist Organization Auditor Date Page 1 Std. 4.1 General s a. Are processes identified b. Sequence & interaction of processes determined? c. Criteria for operation
More informationBusiness Analysis Essentials
Understand the business analyst's role and responsibilities in a successful project. In this introductory course, you'll delve into the role and responsibilities of the business analyst (BA)- the communication
More informationCOST/FUNDING SOURCE: $549,050/FY2014 and FY2015 Uniform Rate
AGENDA ITEM C3 DATE: April 7, 2014 TO: FROM: SUBJECT: Matt Jordan, General Manager Charles H. Carden, Chief Operating Officer Computerized Maintenance Management System Implementation Services Award Contract
More informationPharma IT journall. Regular Features
Pharma IT journall The dedicated publication for those working with Computerised Systems, Processes and Software in the Pharmaceutical, Biotechnology, Medical Device, Clinical Research and Supporting Industries
More informationThe Software Life Cycle. CSE 308: Software Engineering
The Software Life Cycle CSE 308: Software Engineering 1 Life Cycle Models A software life cycle model represents all of the activities and work products necessary to develop a software system Life cycle
More informationObjectives. The software process. Basic software process Models. Waterfall model. Software Processes
Software Processes Objectives To introduce software process models To describe three generic process models and when they may be used To describe outline process models for requirements engineering, software
More informationTest Plan (a Real Sample) SoftwareTestingHelp.com Live Project Training - OrangeHRM
www.softwaretestinghelp.com Test Plan (a Real Sample) SoftwareTestingHelp.com Live Project Training - OrangeHRM 2/1/2014 SoftwareTestingHelp.com Name of the tester Note: This is a sample test plan created
More informationPharma CloudAdoption. and Qualification Trends
Pharma CloudAdoption and Qualification Trends OurCloudExperience Numerous implementations of EDMS systems with external hosting for smaller life science clients Development of qualification strategy for
More informationSoftware Development Process Models
Software Development Process Models Balasankar C S1 M.Tech CSE 1 / 24 Software Development Process Models Activities directly related production design, coding, testing Specifies major development & quality
More informationThe software process. Generic software process models. Waterfall model. Software Development Methods. Bayu Adhi Tama, ST., MTI. bayu@unsri.ac.
The software process Software Development Methods Bayu Adhi Tama, ST., MTI. bayu@unsri.ac.id A structured set of activities required to develop a software system Specification; Design; Validation; Evolution.
More informationInternational GMP Requirements for Quality Control Laboratories and Recomendations for Implementation
International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. ludwig_huber@labcompliance.com Overview GMP requirements for Quality Control laboratories
More informationGuidance for electronic trial data capturing of clinical trials
Guidance for electronic trial data capturing of clinical trials 1 st November, 2007 Japan Pharmaceutical Manufacturing Association pg. 1 Table of Contents 1. Background... 3 2. Purpose... 3 3. Scope...
More informationPHASE 3: PLANNING PHASE
PHASE 3: PLANNING PHASE The ning Phase focuses principally on required project planning work. Proper comprehensive project planning is essential to a successful IT project, and incomplete project planning
More informationPHASE 3: PLANNING PHASE
PHASE 3: PLANNING PHASE The Planning Phase focuses principally on required project planning work. Proper comprehensive project planning is essential to a successful IT project, and incomplete project planning
More informationQuality management systems
L E C T U R E 9 Quality management systems LECTURE 9 - OVERVIEW Quality management system based on ISO 9000 WHAT IS QMS (QUALITY MANAGEMENT SYSTEM) Goal: Meet customer needs Quality management system includes
More informationHow to Survive an FDA Computer Validation Audit
How to Survive an FDA Computer Validation Audit The Myth Within the pharmaceutical, biotech, and medical device industry there is much fear and concern over approaching FDA audits. The FDA strikes fear
More informationSDLC- Key Areas to Audit in IT Projects ISACA Geek Week 2013 8/21/2013. PwC
SDLC- Key Areas to Audit in IT Projects ISACA Geek Week 2013 8/21/2013 1 Introductions and Projects Overview Presenters Charlie Miller and Andrew Gerndt The Coca-Cola Company Principal IT Auditors Atlanta,
More informationTable of Contents. Page 1 of 39
Oracle Health Sciences InForm Cloud Services Service Descriptions and Metrics June 18, 2015 Table of Contents Metric Definitions... 2 Customer... 2 Instance... 2 Patient... 2 Site... 2 Trial... 2 Service
More informationComputer System Configuration Management and Change Control
Computer System Configuration Management and Change Control What Your IT Department Is Really Doing Justin J. Fisher, Pfizer IT Quality and Compliance Manager Agenda 1. Background 2. Audience Demographics
More informationUsing SharePoint 2013 for Managing Regulated Content in the Life Sciences. Presented by Paul Fenton President and CEO, Montrium
Using SharePoint 2013 for Managing Regulated Content in the Life Sciences Presented by Paul Fenton President and CEO, Montrium Overview Informative Webinar that aims to provide an overview of how SharePoint
More informationThe Quality Assurance Centre of Excellence
The Quality Assurance Centre of Excellence A X I S T E C H N I C A L G R O U P A N A H E I M H E A D Q U A R T E R S, 300 S. H A R B O R, B L V D. S U I T E 904, A N A H E I M, CA 92805 PHONE :( 714) 491-2636
More informationTITLE: Control of Software
Page 1 of 8 TITLE: Control of Software WARNING This document is the property of United Technologies Corporation (UTC). You may not possess, use, copy or disclose this document or any information in it,
More informationValidation of Digital Pathology Systems in the Regulated Nonclinical Environment
Validation of Digital Pathology Systems in the Regulated Nonclinical Environment Authors: Jennifer Cann (NIH), Elizabeth Chlipala (Premier Laboratory), Jesus Ellin (Yuma Regional Medical Center), Yoshihiro
More informationSystem Build 2 Test Plan
System Build 2 Test Plan Version 1.0 System Build 2 Test Plan Author s Signature Your signature indicates that this document has been prepared with input from content experts and is in compliance with
More informationElite: A New Component-Based Software Development Model
Elite: A New Component-Based Software Development Model Lata Nautiyal Umesh Kumar Tiwari Sushil Chandra Dimri Shivani Bahuguna Assistant Professor- Assistant Professor- Professor- Assistant Professor-
More informationGOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES. Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme
GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme Contents 1. Why good documentation is essential? 2. What constitutes
More informationUpdating Your Skills from Microsoft Exchange Server 2003 or Exchange Server 2007 to Exchange Server 2010 SP1
Course 10165A: Updating Your Skills from Microsoft Exchange Server 2003 or Exchange Server 2007 to Exchange Server 2010 SP1 OVERVIEW About this Course There are two main reasons for the course. Firstly,
More informationColorado Department of Health Care Policy and Financing
Colorado Department of Health Care Policy and Financing Solicitation #: HCPFRFPCW14BIDM Business Intelligence and Data Management Services (BIDM) Appendix B BIDM Project Phases Tables The guidelines for
More informationValidated SaaS LMS SuccessFactors Viability
Validated SaaS LMS SuccessFactors Viability Executive Summary SuccessFactors has a long history of working with validated organizations and has brought this expertise to their validated SaaS LMS package.
More informationSEVEN KEY TACTICS FOR ENSURING QUALITY
SEVEN KEY TACTICS FOR ENSURING QUALITY 1 INTRODUCTION Besides avoiding disasters and fatal flaws, quality assurance (QA) delivers significant benefits for banks. Strong QA planning provides the groundwork
More informationPHASE 6: DEVELOPMENT PHASE
PHASE 6: DEVELOPMENT PHASE The Phase features a key step in the project: system construction. The previous phases lay the foundation for system development; the following phases ensure that the product
More informationPreparing for an FDA Pre-Approval Inspection (PAI)
Preparing for an FDA Pre-Approval Inspection (PAI) Jorge Torres CMQ/OE, CQE, CQA July, 2007 1 Agenda Introduction Understanding the PAI Experience: What to Expect Inspection Management Plan Preparing for
More informationInternal Control Deliverables. For. System Development Projects
DIVISION OF AUDIT SERVICES Internal Control Deliverables For System Development Projects Table of Contents Introduction... 3 Process Flow... 3 Controls Objectives... 4 Environmental and General IT Controls...
More informationTo introduce software process models To describe three generic process models and when they may be used
Software Processes Objectives To introduce software process models To describe three generic process models and when they may be used To describe outline process models for requirements engineering, software
More informationPowerful information management services and software for the oil, gas, and chemical industries
Powerful information management services and software for the oil, gas, and chemical industries RELIEF SYSTEM SERVICES Provenance Consulting has relief system design experience in all aspects of the petrochemical
More informationWhat is a life cycle model?
What is a life cycle model? Framework under which a software product is going to be developed. Defines the phases that the product under development will go through. Identifies activities involved in each
More informationOverview. Disasters are happening more frequently and Recovery is taking on a different perspective.
Overview Disasters are happening more frequently and Recovery is taking on a different perspective. Defining a Disaster/Disaster Recovery Basic requirements in preparing for a disaster The role of Quality
More informationKern Health System CORE Software Professional Services RFP Responses to Questions/Request for Explanation
Kern Health System CORE RFP Responses to Questions/Request for Explanation Kern Health Systems (KHS) has prepared the following responses to questions received regarding the CORE Request for Proposal (RFP).
More informationSoftware Engineering. Software Processes. Based on Software Engineering, 7 th Edition by Ian Sommerville
Software Engineering Software Processes Based on Software Engineering, 7 th Edition by Ian Sommerville Objectives To introduce software process models To describe three generic process models and when
More informationRevision Date Author Description of change. 10 07Jun13 Mark Benton Removed Admin. Manager from approval
Page 2 of 15 Document Revision History Revision Date Author Description of change 10 07Jun13 Mark Benton Removed Admin. Manager from approval 12Feb13 Mark Benton 08 01Oct12 Mark Benton 07 8/30/2012 Refer
More informationUpdating Your Skills from Microsoft Exchange Server 2003 or Exchange Server 2007 to Exchange Server 2010 Course 10165; 5 Days, Instructor-led
Updating Your Skills from Microsoft Exchange Server 2003 or Exchange Server 2007 to Exchange Server 2010 Course 10165; 5 Days, Instructor-led Course Description There are two main reasons for the course.
More information