Producing a Quality Plan by Tony Simmons is first ina programme ofPharmaceutical Automation Updates, applicable to all regulatedmanufacturers. It shows how professionals at all levels can learn tocope with the increased dependence on automated systems within allhealthcare related industries such as pharmaceuticals, cosmetics,agrochemicals, food etc.
Recommended by top industry professionals.
Software Management Basics by Keith Baker and TonySimmons, second guideinthe Pharmaceutical Automation Updates programme, explains softwaremanagement from the beginnings, moving on to explore theimplementation and deployment of software systems, and how they mustbe managed for compliant drug production. Change control,configuration management and test management are among theactivities explained.
Writing the Validation Report by Christopher Clarkreveals a key area ofcompliancewithin regulatory requirements for those supplying and usingcomputer systems, in the framework of pharmaceutical manufacturing.Validation reports must be written to satisfy the rigorous demandsof many regulators and Christopher, EMEA at Napp Pharmaceuticals,explains this clearly for all professionals. Computer SystemsValidation Life Cycle series.
due Oct. 2001 50 pp
Preparing the Validation Master Plan by Chris Clarkis an overview of the requirements for planning the GMP computerisedsystems critical for the use of formal Validation Plans, showing howto manage and create these documents. Clarifies the roles andresponsibilities for effective planning in the framework of qualityand compliance. CSV Life Cycle Series
System Acceptance Test Specification and Testing byDavid Stokes demonstratesthe value of a careful approach to system acceptance, providingdetailed guidance on the contents of the System Acceptance TestSpecification (SATS). Shows where SATS is placed within the contextof the computer systems validation life cycle with practical adviceon testing methods; a valuable tool for all industry professionalsdealing with IT systems and their validation. Part of the ComputerSystems Validation Life Cycle series.
due Dec. 2001 50 pp
Laboratory Systems Validation Testing and Practiceby Paul Coombes --engineeringand automation professionals need to be familiar with computerisedlaboratory systems, and similarly engineers who currently work incomputer systems validation or classical engineering validation.This guide speaks their language on best testing practices.
due Dec. 2001 About 100 pp
Suppliers Guide to Computer Validation Audits by GuyWingateis intended for thoseinvolved in the use and supply of audited computer systems, softwareand related services. Helps both user and supplier to prepare foraudit, not only to complete them efficiently, but also to presentthemselves to regulators in a professional manner. This guide isbased on work conducted with the GAMP Supplier Forum, and defers toGAMP throughout.
Due Dec. 2001 About 60 pp
The User Requirements Specification by Chris Reidand Barbara Mullendoretakesan interactive approach to the creation of a User RequirementSpecification (URS) and puts this all-important document under themicroscope to provide all the necessary details for developing andimplementing a regulatory compliant URS. Includes timing, templates,requirements ranking, document approvals, format and content,process description and much else. Part of CSV Life Cycle Activities(ed Reid)
The Functional Design Specification by Chris Reid
The mastermind behind our CSV LifeCycle Activities programme, who has many years' experience in CSVincluding Glaxo Wellcome and Eutech Engineering Solutions (now ABBEutech) is Chris Reid, Director and Senior Consultant of his owncompany, Integrity Solutions Limited of Middlesborough, UK. Heexamines the Functional Design Specification, explaining thedevelopment of a fully traceable specification which can betranslated into the software code and system configuration. Includedhere is GAP analysis, traceability matrix, document approvals andchange control issues.
Hardware Acceptance Test Specifications and Testingby David Stokes is a guideto hardware in the CSV life cycle, with detailed guidance to contentof the hardware acceptance test specification and how it related tothe CSV project as a whole. Practical advice on testing in practice,the guide reflects David's many years experience with IT andautomated systems.
Electronic Records and Electronic SignaturesCompliance Assessment byChris Reid and Barbara Mullendore provides practical guidance onthe interpretation of 21 CFR Part 11 and the steps you need to taketo address current and future compliance issues. This quick guide isdesigned to help you identify ERES business benefits, establishpolicies, procedures, and processes that ensure compliance, anddefine and evaluate system requirements. Topics covered include:Procedural and administrative controls including details aboutpolicies, training, systems.
A DHI/PDA publication
CSV TECHNICAL REPORTS SERIES Orlando Lopez
A programme of concise clear guides all written by Orlando Lopez,who is Computer Systems Validation Senior Consultant for McNeilConsumer Products at Fort Washington, USA.
21 CFR 11 Compliance Assessment System
Documents the GxP compliance analysis for hybrid, closed systemsbased on the Subpart B in 21 CFR Part 11 – ERES Rule. Theelectronic signature function is separately addressed in the titleabove.
Spreadsheet Qualification Applications
Examines the test cases to be executed as part of the qualificationof these applications based on final 21 CFR Part 11 ruling, theAmerican Society for Testing and Materials, and current ComputerSystems Validation (CSV) practices.
Retrospective Validation Plan for Computer-RelatedSystems
Identifies legacy systems to be retrospectively validated,procedures to be followed during associated processes, expectationsfor a retrospective validation of a controlled process. Falls inline with current GMP requirements to help ensure that legacysystems operate correctly.
Automated Batch Record Systems and QualificationTest CasesBatch records involvearrangement of discrete control actions, regulatory control actions,sequencing, logic decisions, variable calculations, alarmconditions, and failure modes: as well as instruction on making thebatch product, the batch record documentation records, QA approvals,and product testing. Here Orlando examines the test cases to beexecuted as part of the qualification of an Electronic Batch Record(EBR) system, based on final 21 CFR Part 11 ruling and current CSV.
Regulatory Systems Hardware Specifications
Step-by-step examination of the approach to qualification ofcomputerised hardware associated with regulatory process controlsystems. An overview that includes computer hardwarecharacteristics, qualification methodology, documentation ofcritical hardware and peripheral components, verification ofsupporting utilities, calibration, wiring, loops, operationalprocedures. Presents the validation project plan and all itscomponents, complete with helpful figures, lists and charts.
Qualification of Computer Networks
Based on such issues as 21 CFR Part 11, FDA Compliance PolicyGuidelines, and the Draft GAMP SIG "Validation of the ITInfrastructure", Orlando explains qualification of cable mediaand associated hardware/communication software interconnectingautomated systems. Step-by-step guidance is given on a ManufacturingExecution System (MES), including ERP 11, quality management,validation requirements and documents to be adapted or copied.
Qualification of SCADA (Supervisory Control and DataAcquisition) Systems
Following the introduction of 21 CFR Part 11, which establisheddetailed requirements for the qualification of computerised systems,Orlando fills the need for guidance to the Factory Acceptance Testand implementation of SCADA systems.
Supplier Computer Systems ValidationResponsibilities
This quick guide defines an approach to incorporating softwaresuppliers/integrators early in software projects and effectivelycoordinating project activities to significantly reduce the cost ofvalidation. Timely and clear, the author details the System LifeCycle (SLC) of the software, shows how supplier support is vital toComputer System Validation (CSV), offers Detailed DocumentationChecklist to ensure that all necessary areas are covered. The casereferenced in the guide is for a computer system controlling amanufacturing process.
ISBN to be advised
Qualification of Computer NetworksThis document describes thequalifications of the cable modem, associated hardware, andcommunication software that interconnect automated systems in apharmaceutical manufacturing environment. It also contains sampledata collection forms to record the installation of a repeater foran Ethernet network system.
ISBN to be advised