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Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Second Edition

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Second Edition
Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Second Edition
  • Συγγραφείς: Guy Wingate ,  Glaxo Smith Kline ,  Durham
  • ISBN: 9781420088946
  • Εκδότης: Informa Healthcare
  • Σελίδες: 798
  • Έτος Έκδοσης: 2010
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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

•GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
•ICH Guidance Q8, Q9, and Q10 expectations
•FDA cGMPs for the 21st Century Initiative and associated guidance
•PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
•WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
•the indirect developments from FDA/EU/Japan regulators and industry
•the role of QA department, and internal and external suppliers
•the integration of computer systems validation into single overall approach for wider system
•practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
•managing outsource partners and handling legacy systems
•topical issues uncovered by regulatory authorities including US FDA

    Introduction

     

  • Strategic advantage

     

    Rudimentary computer system characteristics. Trends in today’s computing environment

     

  • Problems implementing computer systems

     

    Industry observations. Regulatory observations

     

  • New 21st century paradigm

     

    Key principles & terminology. Life cycle approach within qms. Scaleable life cycle. Activities. Process and product understanding. Science based quality risk management. Leveraging supplier involvement

     

  • Good practice

     

    Quality assurance. Gxp philosophy. Duty of care. Buyer beware

     

  • Business case

     

    Benefits. Implementation cost. Cost of failure. Measuring success. Misconceptions

     

  • Good business sense

     

  • Persistent regulatory non-compliance

     

  • Wider applicability

     

    History of computer validation

     

  • A regulatory perspective

     

    Significant regulatory developments. Good manufacturing practice (gmp). Good distribution practice (gdp). Good laboratory practice (glp). Good clinical practice (gcp). Medical devices. Electronic records and electronic signatures (eres). Collective gxp requirements

     

  • Developing industry guidance

     

    Pma’s concept paper. Red apple consensus report. Gamp supplier guide. Pda’s technical report on computer validation. Phrma’s computer validation key practices. Gamp3. Pda/gamp harmonised terminology. Gamp infrastructure & pda network guidance. Pda technical report on laboratory systems. Gamp4. Pda/ispe good practice & compliance for part 11. Gamp guide for electronic signatures & records. Pic/s gxp computerised system guidance. Gamp5. Body of knowledge

     

  • Pivotal inspection incidents

     

    Organisation & management

     

  • Organisational responsibilities

     

    Quality & compliance roles. Concept of internal supplier. External supplier responsibilities. Recent inspection findings

     

  • Compliance strategy

     

    Organisation considerations

     

  • Policy & procedures

     

    Recent inspection findings

     

  • Computer systems inventory

     

     

  • Project delivery

     

    Getting started. Life cycle approach. Risk management. Recent inspection findings

     

  • Management review

     

    Recent inspection findings

     

  • Resource planning

     

     

  • Key principles for computer system compliance

     

    Supporting processes

     

  • Training

     

    Organisational roles. Qualifications. Training plans & records. Recent inspection findings

     

  • Document management

     

    Document preparation. Document review. Document approval. Document issue. Document change. Document withdrawal. Document administration & storage. Quality of documentation. Recent inspection findings

     

  • Change control

     

    Request for change. Change evaluation (impact analysis) and authorisation. Testing and implementation of the change. Change completion and approval. Emergency changes. Recent inspection findings

     

  • Configuration management

     

    Configuration identification. Configuration control. Configuration status accounting. Configuration evaluation. Recent inspection findings

     

  • Self-inspections

     

     

  • Managing deviations

     

     

  • Example self-inspection checklist

     

    Approach to project delivery

     

  • Approach to validation

     

    Standard software. Commercial off-the-shelf (cots) products. Open source software. Software tools. Managing user modifications. Software reuse. Managing change. Roles & responsibilities

     

  • Choosing an appropriate life cycle methodology

     

    Integrating systems. Segregating systems

     

  • Project initiation & compliance determination

     

    Project scope (outline specification). Compliance determination. Validation (master) planning. Project & quality plans

     

  • Requirements capture & supplier (vendor) selection

     

    User requirements specification (urs). Gxp assessment. Request for, receipt of, and evaluation of proposals. Supplier selection. Purchase orders and contracts of supply

     

  • Design & development

     

    Supplier project & quality plan. System overview. Functional specification. Architectural design. Hardware and software design. Data definition (inc. Configuration). Operating manuals. Design review (inc. Hazard study)

     

  • Coding, configuration & build

     

    Hardware platform. Application software. Source code review

     

  • Development testing

     

    Unit/module testing. System/integration testing. Pre-delivery inspection

     

  • User qualification & authorisation to use

     

    Pre-qualification activities (commissioning & calibration). Data load (inc. Configuration). Installation qualification (iq). Operational qualification (oq). Performance qualification (pq). Operation and maintenance pre-requisites. Validation (summary) reports

     

  • Project delivery supporting processes

     

    Training. Document management. Change management. Configuration management. Requirements traceability. Deviation management

     

  • Validation package

     

    Reviews and approvals

    Project initiation & compliance determination

     

  • Project scope

     

    Understanding the scope of the computer system. Outline specification. Project risk management. Project & quality plans. Glossary of terms

     

  • Validation determination

     

    Early indication of validation requireme

     

    nt. Compliance determination statement

     

  • Validation master plan Hierarchy of validation master plans. Contents of validation master plans. Structure of validation master plans. Preparation of a validation master plans. Recent inspection findings

     

  • Validation plan

     

    Contents of validation plan. Preparation of a validation plan. Supplier relationships.magnitude of validation effort. Recent inspection findings

     

  • Validation strategy

     

    Approach to hardware. Approach to software. Criticality-impact analysis. Managing compliance issues

     

  • Example validation determination statement

     

     

  • Example contents for validation master plan

     

     

  • Example contents for validation plan

     

    Requirements capture & supplier (vendor) selection

     

  • User requirements specification

     

    Contents. Electronic record/signature requirements. Recent inspection findings

     

  • GXP assessments

     

    Identifying gxp processes and functions. Identifying critical components and devices. Recent inspection findings

     

  • Supplier selection

     

     

    Regulatory expectations. Invitation to tender. Supplier proposal. Proposal evaluation. Contract of supply. Recent inspection findings

     

  • Supplier audits

     

    Applicability. Audit preparations. Conducting audits. Audit report & follow-up. Preferred suppliers. User groups. Recent inspection findings

     

  • Example contents for urs

     

     

  • Supplier checklist for receiving customer audits

     

     

  • Example postal supplier audit questionnaire

     

     

  • Example supplier audit checklist

     

     

  • Example contents for supplier audit report

     

    Design & development

     

  • Supplier project and quality plans

     

     

  • Functional specification

     

    Content. Dealing with cots products. Anticipating testing. Recent inspection findings

     

  • Requirements traceability

     

    Contents. Maintenance. Recent inspection findings

     

  • Architectural design

     

    Content. Recent inspection findings

     

  • Software & hardware design

     

    Software design. Hardware design. Dealing with cots hardware and software. Recent inspection findings

     

  • Design review (inc. Hazard study)

     

    Haccp. Chazop. Fmea. Dealing with cots hardware and software. Recent inspection findings

     

  • Accelerated development

     

    Prototyping. Rapid application development. Extreme programming

     

  • Contents for supplier project/quality plan

     

     

  • Example checklist for functional specification

     

     

  • Example software design structure

     

     

  • Example hardware design structure

     

     

  • Example hazard study questions

     

    Coding, configuration, and build

     

  • Software programming

     

    Programming approach. Redundant code (‘dead code’). Compilers. Recent inspection findings

     

  • Source code review

     

    Review criteria. Reporting. Effectiveness. Access to application code. Recent inspection findings

     

  • system assembly

     

     

  • Checklist for software production, control & issue

     

     

  • Example programming standards

     

     

  • Example checklist for software code reviews

     

    Development testing

     

  • Testing strategy

     

    Test plans. Test specifications. Test conditions. Test traceability. Text execution. Independent checks. Test outcome. Inconsequential test deviations. Test failures. Issues log. Test reporting. Managing changes during testing. Test environment. Inspection findings

     

  • Unit & integration testing

     

    Structural (white-box) testing. Acceptance testing of cots software and hardware. Inspection findings

     

  • System testing

     

    Functional (black-box) testing. Upgrade compatibility. Inspection findings

     

  • Pre-delivery inspection

     

    User qualification & authorisation to use

     

  • Qualification

     

    Test documentation. Leverage development testing. Beta testing. Stress testing. Parallel operation. Inspection findings

     

  • Pre-qualification

     

    Site preparations. Calibration. Data load. Inspection findings

     

  • Installation qualifcation

     

    Inventory checks. Operating environment checks. Diagnostic checks. Documentation. Inspection findings

     

  • Operational qualification

     

    Scope of testing. Test reduction. Verifying sops. Test environment. System release. Inspection findings

     

  • Performance qualification

     

    Product performance qualification. Process performance qualification. Inspection findings

     

  • Authorisation to use

     

    Validation report. Validation summary report. Validation certificate. Inspection findings

    Operation & maintenance

     

  • Performance monitoring

     

    Monitoring plan. Status notification. Recent inspection findings

     

  • Repair & preventative maintenance

     

    Scheduling. Calibration. Documentation. Recent inspection findings

     

  • Upgrades, bug-fixes and patches

     

    Why upgrade? Bug-fixes & patches. Installation & validation. Upgrade considerations. Beta software. Quick fix. Availability of software & reference documentation. Prioritising changes. Ecent inspection findings

     

  • Data maintenance

     

    Data life cycle. Audit trails. Retention of raw data. Recent inspection findings

     

  • Backup and retrieval

     

    Scheduling. Media. Recent inspection findings

     

  • Archive and restoration

     

    Archiving requirements. Retrieving archives. Storage requirements. Recent inspection findings

     

  • Business continuity planning

     

    Procedures & plans. Redundant systems & commercial hot sites. Service bureau. Backup agreements. Cold sites. Manual ways of working. Software licences. Recent inspection findings

     

  • Security Management. Computer viruses. Recent inspection findings

     

  • Contracts and service level agreements (slas)

     

    Recent inspection findings

     

  • User procedures

     

    Recent inspection findings

     

  • Periodic review

     

    Recent inspection findings

     

  • Revalidation

     

    Recent inspection findings

    Phase-out & withdrawal

     

  • Site closures, divestments & acqusitions

     

    Site closures. Site divestments. Site acquisitions

     

  • Retirement

     

    Electronic records management. Preservation of archive records. Duration of retention. Archiving options

     

  • Replacement

     

    Migration strategy. Legacy systems

     

  • Decommissioning

     

     

  • Example retirement checklist

     

     

  • Electronic records & electronic signatures

     

     

  • Electronic records

     

    Record life cycle. Audit trail. Timestamps. Meta-data. Record maintenance. Software programs & configuration. Recent inspection findings

     

  • Electronic signatures

     

    Admissability. Signature attributes. Linking a signature to an electronic record. Identification codes and passwords. Digital signatures. Recent inspection findings

     

  • Operating controls

     

    Device checks. Sequence checks. Continuous sessions system access. Open and closed systems. Recent inspection findings

     

  • Expected good practice

     

    Validation. Backups & archive. Training. Security. Business continuity plans. Recent inspection findings

     

  • Implications for new systems

     

    Hazard study. Common practical issues

     

  • Implications for existing systems

     

    Regulatory expectations. Management approach. Master plans. Recent inspection findings

     

  • Example electronic records

     

     

  • Example electronic signatures

     

     

  • Procedural and technological controls for 21 cfr part 11

     

     

  • Risk management

     

     

  • Project initiation & compliance determination

     

    Compliance determination

     

  • Requirements capture & supplier (vendor) selection

     

    User requirements specification. Supplier assessment

     

  • Design & development

     

    Design specification (inc. Functional specification). Design review

     

  • Coding, configuration & build

     

    Programming standards & source code review

     

  • Development testing

     

    Supplier testing

     

  • User qualification & authorisation to use

     

    Data loading. Installation qualification. Operational qualification. Performance qualification. System release

     

  • Operation & maintenance

     

    Software support. Service level agreements

     

  • Phase-out & replacement

     

    Archiving. Data migration. Decommissioning

     

  • Outsourcing

     

     

  • Regulatory requirements

     

     

  • Planning & supervision

     

     

  • Organisational capability

     

     

  • Dis-entanglement

     

     

  • Ongoing oversight

     

     

  • Handling legacy systems

     

     

  • Setting priorities

     

     

  • Hazard control

     

     

  • Interim measures

     

     

  • Validation activities

     

     

  • Recent inspection findings

     

     

  • Regulatory inspections

     

     

  • Inspection authority

     

     

  • Inspection practice

     

    Approach to organisational capability. Approach to individual computer systems. Mutual recognition agreements

     

  • Inspection process

     

    Receiving an inspection request. Preparing for an inspection. Hospitality. Arrival of the inspector(s). Conducting the inspection. Daily wash-up with inspector. After the inspection. Inspection findings. Poor excuses. Iso 9000 and validation

     

  • Ensuring a state of inspection readiness

     

    Inventory of systems. System/project overviews. Validation plans/reports and reviews. Documentation. Presentations. Internal audit program. Mock inspections. Trained personnel. Knowledge management

     

  • Providing electronic information during an inspection

     

    Provision of electronic documents and reports. Provision of electronic copies of desktop applications. Provision of electronic records. Direct access to electronic information by regulators. Use of computer systems by regulators. Copies of electronic information

     

  • Inspection analysis

     

     

  • Pre-Inspection Questionnaire

     

     

  • GLP inspection checklist

     

     

  • GMP inspection checklist

     

     

  • Electronic record/signature inspection checklist

     

     

  • Recent fda warning letters

     

     

  • Capabilities & performance

     

     

  • Capability management

     

    Capability appraisal. Capability characteristics. Capability assessment outcomes. Supplier capability assessments

     

  • Project metrics

     

    Design & development metrics. Testing metrics. Understanding contributory factors

     

  • Operation & maintenance maxims

     

    Dependable operation. Change management

     

  • Process improvement

     

    Lean. Six sigma

     

  • Capabiliy questionairre

     

     

  • Six sigma tool kit

     

     

  • Concluding remarks

     

     

  • The business case for validation

     

     

  • Industry consensus

     

     

  • Golden rules remain unchanged

     

     

  • Risk management

     

     

  • Key role of suppliers

     

     

  • Organisational change

     

     

  • The final analysis

     

     

  • Appendix

     

     

  • Using statistical tools

     

     

  • Approach to projects. Approach to data. Approach to change control. Recent inspection findings

    Error rate tables

    Volume 2: case studies

     

  • Analytical laboratory instruments

     

     

  • Chromatography data systems (cds)

     

     

  • Laboratory information systems (lims)

     

     

  • Clinical systems

     

     

  • Control instrumentation

     

     

  • Programmable logic controllers (plcs)

     

     

  • Industrial personal computers

     

     

  • Supervisory control and data acquisition (scada) systems

     

     

  • Distributed control systems (dcs)

     

     

  • Electronic batch record systems (manufacturing execution systems)

     

     

  • Integrated automation systems

     

     

  • Building management systems (bms)

     

     

  • Engineering management systems

     

     

  • Spreadsheets

     

     

  • Databases

     

     

  • Electronic document management systems (edms)

     

     

  • Manufacturing resource planning (mrp ii) systems

     

     

  • Marketing & supply systems

     

     

  • Infrastructure & associated services

     

     

  • Networks

     

     

  • Web applications

     

     

  • Medical devices

     

     

  • Blood processing

     

     

  • Process analytical technology

     

 

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