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Medical Device Manufacturers use Rational

traceability
9 of Top 10

Pharmaceutical Companies use Rational

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System software and Hardware Categorization
Electronic Records and Electronic Signatures (ERES) Assessment
GxP Impact Assesment
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Supplier Assesment
Risk Management
Validation Plan (VP)
System overview
User Requirements Specification
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Backup and Restore
Continuity planning and Testing Disaster Recovery
Periodic Review
Data Archive & Retrieval
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Decommissioning
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Requirements Traceability
Change Management
Incident / Deviation Management
Document and Configuration Management
Access and Security Management
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Concept Phase

The concept phase addresses early evaluation and planning activities to determine if an automated solution is suitable for supporting a specific business process. High level assessments of benefits and costs may be considered to justify further investment in pursuing potential computerized solutions.

concept-phase

System Hardware and Software Categorization

The following GAMP 4 software and hardware categories are used to establish the validation approach and determine the deliverables.

Infrastructure Software

Unless a very simple control system (PLC and HMI) there is likely to be some elements of infrastructure software.

Infrastructure software in its most simple form is the operating system which the application software resides.

Additional software for managing the infrastructure the process control system includes:

  • Operating Systems
  • Anti-virus Software
  • Active Directory / Domain Controller
  • Database Software (SQL / Oracle)
  • Server and Network Hardware
  • Virtual Environments
  • Firewalls, including configuration
  • Server and Network Monitoring Tools
  • Backup Systems

Project Phase

Based upon a decision to proceed from conceptual planning, the project phase covers all aspects of system development and implementation. Multiple sub-phases support a controlled approach to providing a compliant computerized solution to support the regulated business process. Each sub-phase will produce key deliverables that provide evidence that the system is fit for its intended purpose, i.e., Computer System Validation.

concept-phase
Supplier Assesment

The system supplier must be assessed to determine their suitability to provide a quality system that meets all requirements. Confidence will be gained through their adherence to a documented Quality Management System and Software Development Life Cycle (SDLC). The assessment may take the form of a basic checklist, a postal questionnaire, or an onsite audit, depending on the outcome of the risk assessment. Supplier selection should then be documented in a report, along with whether the supplier documentation will be leveraged or not.

Code Review

If applicable, a code review is performed to detect and fix coding errors before the system goes into formal testing. It verifies that the software has been developed in accordance with the design and programming standards have been followed.

Operational Phase

The Operational phase of the typical System Life Cycle is supported primarily through Standard Operating Procedures developed and verified as key deliverables during system development. 

concept-phase

Key processes to consider include incident and problem management, system backup and recovery, system administration, change and configuration management, ongoing access controls, and periodic review. 

Emphasis is on maintaining a controlled and validated state for the system through the remainder of its life.

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Backup and Restore

Backup and restore is a routine process consisting of copying software, data and electronic records to a separate safe and secure area. This information is protected, available and when required, able to be restored, uncorrupted in its original format. 

Backup and restore is not the same as the archiving and retrieval processes.

Retirement Phase

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Decomissioning
 

Eventually, any system will reach the end of its productive life, often driven by advances in technology and changes in the needs of supported business processes. The final phase of the typical SLC focuses on activities that are important for the effective decommissioning of the system and transition to a new system to support it. Particular attention should be given to the migration or archive of critical business data to ensure its retention is consistent with company policies and regulatory requirements.

A decommissioning plan must be prepared for systems that are to be retired from operational service so that the process is documented and controlled. Consideration must be taken into account with regards to the archiving of data and records retention requirements, along with any hardware disposal. 

Multi-phase

concept-phase
Requirements Traceability

Traceability must be documented to identify the connection between the results 

of the risk assessment, via the requirements specification, 

design and through all testing to individual test cases.

 
 
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