Producing a Quality Plan by Tony Simmons is first in a programme ofPharmaceutical Automation Updates, applicable to all regulated manufacturers. It shows how professionals at all levels can learn to cope with the increased dependence on automated systems within all healthcare related industries such as pharmaceuticals, cosmetics, agrochemicals, food etc.
Recommended by top industry professionals.
Software Management Basics by Keith Baker and Tony Simmons, second guide in the Pharmaceutical Automation Updates programme, explains software management from the beginnings, moving on to explore the implementation and deployment of software systems, and how they must be managed for compliant drug production. Change control, configuration management and test management are among the activities explained.
Writing the Validation Report by Christopher Clark reveals a key area ofcompliance within regulatory requirements for those supplying and using computer systems, in the framework of pharmaceutical manufacturing. Validation reports must be written to satisfy the rigorous demands of many regulators and Christopher, EMEA at Napp Pharmaceuticals, explains this clearly for all professionals. Computer Systems Validation Life Cycle series.
due Oct. 2001 50 pp
Preparing the Validation Master Plan by Chris Clark is an overview of the requirements for planning the GMP computerised systems critical for the use of formal Validation Plans, showing how to manage and create these documents. Clarifies the roles and responsibilities for effective planning in the framework of quality and compliance. CSV Life Cycle Series
System Acceptance Test Specification and Testing by David Stokesdemonstrates the value of a careful approach to system acceptance, providing detailed guidance on the contents of the System Acceptance Test Specification (SATS). Shows where SATS is placed within the context of the computer systems validation life cycle with practical advice on testing methods; a valuable tool for all industry professionals dealing with IT systems and their validation. Part of the Computer Systems Validation Life Cycle series.
due Dec. 2001 50 pp
Laboratory Systems Validation Testing and Practice by Paul Coombes --engineering and automation professionals need to be familiar with computerised laboratory systems, and similarly engineers who currently work in computer 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 Guy Wingate is intended forthose involved in the use and supply of audited computer systems, software and related services. Helps both user and supplier to prepare for audit, not only to complete them efficiently, but also to present themselves to regulators in a professional manner. This guide is based on work conducted with the GAMP Supplier Forum, and defers to GAMP throughout.
Due Dec. 2001 About 60 pp
The User Requirements Specification by Chris Reid and Barbara Mullendoretakes an interactive approach to the creation of a User Requirement Specification (URS) and puts this all-important document under the microscope to provide all the necessary details for developing and implementing 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 Life Cycle Activities programme, who has many years' experience in CSV including Glaxo Wellcome and Eutech Engineering Solutions (now ABB Eutech) is Chris Reid, Director and Senior Consultant of his own company, Integrity Solutions Limited of Middlesborough, UK. He examines the Functional Design Specification, explaining the development of a fully traceable specification which can be translated into the software code and system configuration. Included here is GAP analysis, traceability matrix, document approvals and change control issues.
Hardware Acceptance Test Specifications and Testing by David Stokes is a guide to hardware in the CSV life cycle, with detailed guidance to content of the hardware acceptance test specification and how it related to the CSV project as a whole. Practical advice on testing in practice, the guide reflects David's many years experience with IT and automated systems.
Electronic Records and Electronic Signatures Compliance Assessment by Chris Reid and Barbara Mullendore provides practical guidance on the interpretation of 21 CFR Part 11 and the steps you need to take to address current and future compliance issues. This quick guide is designed to help you identify ERES business benefits, establish policies, procedures, and processes that ensure compliance, and define and evaluate system requirements. Topics covered include: Procedural and administrative controls including details about policies, 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 McNeil Consumer Products at Fort Washington, USA.
21 CFR 11 Compliance Assessment System
Documents the GxP compliance analysis for hybrid, closed systems based on the Subpart B in 21 CFR Part 11 – ERES Rule. The electronic signature function is separately addressed in the title above.
Spreadsheet Qualification Applications
Examines the test cases to be executed as part of the qualification of these applications based on final 21 CFR Part 11 ruling, the American Society for Testing and Materials, and current Computer Systems Validation (CSV) practices.
Retrospective Validation Plan for Computer-Related Systems
Identifies legacy systems to be retrospectively validated, procedures to be followed during associated processes, expectations for a retrospective validation of a controlled process. Falls in line with current GMP requirements to help ensure that legacy systems operate correctly.
Automated Batch Record Systems and Qualification Test Cases
Batch records involve arrangement of discrete control actions, regulatory control actions, sequencing, logic decisions, variable calculations, alarm conditions, and failure modes: as well as instruction on making the batch product, the batch record documentation records, QA approvals, and product testing. Here Orlando examines the test cases to be executed 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 of computerised hardware associated with regulatory process control systems. An overview that includes computer hardware characteristics, qualification methodology, documentation of critical hardware and peripheral components, verification of supporting utilities, calibration, wiring, loops, operational procedures. Presents the validation project plan and all its components, complete with helpful figures, lists and charts.
Qualification of Computer Networks
Based on such issues as 21 CFR Part 11, FDA Compliance Policy Guidelines, and the Draft GAMP SIG "Validation of the IT Infrastructure", Orlando explains qualification of cable media and associated hardware/communication software interconnecting automated systems. Step-by-step guidance is given on a Manufacturing Execution System (MES), including ERP 11, quality management, validation requirements and documents to be adapted or copied.
Qualification of SCADA (Supervisory Control and Data Acquisition) Systems
Following the introduction of 21 CFR Part 11, which established detailed requirements for the qualification of computerised systems, Orlando fills the need for guidance to the Factory Acceptance Test and implementation of SCADA systems.
Supplier Computer Systems Validation Responsibilities
This quick guide defines an approach to incorporating software suppliers/integrators early in software projects and effectively coordinating project activities to significantly reduce the cost of validation. Timely and clear, the author details the System Life Cycle (SLC) of the software, shows how supplier support is vital to Computer System Validation (CSV), offers Detailed Documentation Checklist to ensure that all necessary areas are covered. The case referenced in the guide is for a computer system controlling a manufacturing process.
ISBN to be advised
Qualification of Computer Networks
This document describes the qualifications of the cable modem, associated hardware, and communication software that interconnect automated systems in a pharmaceutical manufacturing environment. It also contains sample data collection forms to record the installation of a repeater for an Ethernet network system.
ISBN to be advised