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Small control systems, e. Usually delivered embedded in a unit or machine Multi-discipline engineering effort required to produce Much of the lifecycle documentation produced by supplier.
Lifecycle ref. Draft Figs 3. Provide a structured definition of system requirements Enable requirement traceability matrix Allow complimentary lifecycle documents to be developed Support focused and auditable system development Establish test acceptance criteria Support maintenance of the system. For small embedded applications, could be part of equipment specification For large standalone applications, e.
Embedded System FS may be part of overall equipment specifications, including instrument, electrical, and mechanical elements. Standalone System FS typically one document, identifying the functions, features and the design intentions for the system hardware and software. Functions to be performed Facilities to be provided Detailed process sequence logic and interlocks Interfaces to instruments, equipment, and other systems. Basis of subsequent testing and verification, e.
System Acceptance Testing Divergence with the URS to be identified Should identify any software functions that are not being utilised Often a contractual document subject to Change Control by Supplier. Design Specifications Specifications for system design: Software Hardware Instrumentation may include mechanical and electrical general arrangement drawings.
Showing process flow Identification and location of associated control and monitoring loops Identification and location of major items. Connections to field instrumentation Wiring termination, identification, rating, and polarity Sufficient detail to enable assembly, installation, and fault diagnosis. Defines how the software is to implement the Functions Specification Defines the software and data structure, architecture, the software modules, their interactions, and interfaces.
Should identify programming standards where coding is involved, and naming conventions in all cases Ensure annotated hardcopy of software software provides clear understanding and can be used testing aid All non-standard software to be identified. Formal and systematic verification that specified requirements are covered by the design and development activities. Supported by a structured set of lifecycle documentation May be a series of reviews throughout system design and development To verify adherence to Requirements Traceability Matrix Can encompass elements of acceptance testing Requirements and Design intentions should be agreed before significant code development Findings to be documented in a Design Review Report.
Proving the correct operation of software, hardware, and instrumentation, as defined by the URS and FS Based on approved Test Specifications, and formally reported Test specifications to include objectives, procedures and acceptance criteria To focus on GxP and other critical functions and data Determine level of testing to support Lifecycle Qualifications. Pre-delivery Normally a contractual milestone For standalone systems - without connection to field instrumentation, with an agreed level of process simulation Testing constraints to be documented Opportunity to identify problems best resolved in Supplier environment.
To determine that the system and any associated equipment has not been damaged, and functions correctly in the operating environment Normally a repeat of the FAT plus tests possible with process, instrumentation, interfaces, and service connections in place With adequate level of test procedures may be combined with engineering commissioning to provide necessary test data for IQ and OQ. Pre- and post-delivery, to defined, approved procedures Test equipment documented, and traceable back to acceptable standards Calibration test results retained Establish calibration interval depending on criticality, robustness, sensitivity, and operational experience.
Decommissioning to include archiving data and software Archive Report to describe approach, list documents, raw data, and electronic records Verification of critical instrument calibration Special care with preservation and availability of GxP records throughout their retention period, as required by of 21 CFR Part 11, and associated predicate rules.
GAMP Principles - can be applied effectively to process control systems, both embedded and standalone Good Engineering Practice - normal engineering commissioning activities can support the requirements of Qualification testing. Whats next? Learn more about Scribd Membership Home. Much more than documents. Discover everything Scribd has to offer, including books and audiobooks from major publishers.
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