Site acceptance test

Validation of the SIS functionality is performed as part of a site acceptance test (SAT). Validation involves a full functional test that demonstrates the SIS actually works in the real-world installation. It proves the SIS devices execute the logic according to the specification and ensures that the SIS and its devices interact as intended with other systems, such as the BPCS and operator interface. From a systematic error standpoint, the SAT also provides an opportunity for a first-pass validation of the procedures developed for the operating basis (see next subsection). 

DQ is performed by the supplier of the equipment or system at the supplier s factory as part of the factory acceptance test (FAT). IQ (based on site acceptance test—SAT), OQ, and PQ are performed on-site at the GMP facility. For a GMP manufacturing facility, the validation activities include the facility design, FTVAC system, environment control, laboratory and production equipment, water system, gases and utilities, cleaning, and analytical methods. Validation protocols (IQ, QQ, and PQ) are prepared for each item, listing all critical steps and acceptance criteria. Deviations are reviewed and resolved before the validation activity proceeds to the next phase. 

The FDS will also form the basis for contractual acceptance testing, both at the supplier s premises (factory acceptance test, FAT) and on delivery to the site (site acceptance test, SAT). With suitably compiled test procedures these traditional contractual acceptance tests may be incorporated with the qualification testing required by the validation life cycle. 

Once the computer system has been delivered to the pharmaceutical manufacturer s site and is installed and connected through field cabling and tubing to instrumentation (and possibly other systems) it is ready for site acceptance testing—this for both critical and noncritical parameters and functions. The in situ acceptance testing of the system under the SAT is a key element of engineering commissioning. For continuity, SAT test results should be analyzed and compared to the FAT results. 

The site acceptance testing also provides an opportunity to identify and correct any problems due to shipping, utility hookup, hardware assembly, and field installation. The extent of SAT required can be determined by the completeness of the FAT, and as such is a full or partial repeat of the acceptance test specification with connections to the field instrumentation and regulating devices. Where it is not considered necessary to conduct a full repeat of the FAT, the rationale for this decision should be recorded in the qualification report. 

The level of site acceptance testing should be such as to demonstrate satisfactory operation of the system functions in conjunction with the manufacturing process equipment and may involve control loop tuning. Site acceptance testing in its basic form should include installation checks, power-up, diagnostic checks, and commissioning of process and safety-related operational I/O, controls, sequencing, interlocks, alarms, and reports. 

Site acceptance test plan and results are documented (if applicable)... 

Site Acceptance Test (SAT) An acceptance test at the customer s site, usually involving the customer (IEEE). 

Equipment testing Ventilation testing to ensure proper function and operation required. For containment devices, factory acceptance testing and site acceptance testing should be completed... 

Site Acceptance Tests (SATs) generally carried out by the site installation engineers in conjunction with the manufacturer, ensures that the equipment is installed appropriately and still meets the requirements of the FATs. Any damage occurring before or during shipping will be spotted at this point. 

User/site acceptance testing of compnterized systems (known as qualihcation) must cover installation, operation, and performance in the wider system context inclnding equipment, processes, and operator interaction (i.e.. Installation Qnalihcation, Operation Qualification, and Performance Qualification). 

Confirmation that all tests or verification were executed and witnessed (if applicable) by suitably qualified and authorized personnel. This includes all supplier factory testing and site acceptance testing... 

Suppliers conduct factory and site acceptance testing (FAT, SAT). Testing carried out at the factory includes hardware and software tests. Successful completion of the tests allows shipment of the IPC system to site. Tests include ... 

Testing is condncted in several phases depending on the complexity of the software design. The snpplier shall be responsible for developing modnle, integration, factory, and site acceptance test specifications to demonstrate that the design has been fully and accurately implemented. 

There are two questions most commonly faced by validation organizations "What do we validate " and "How does validation differ from normal project activities such as Factory Acceptance Testing and Site Acceptance Testing " The answers are that we validate GxP critical aspects of the system, i.e., those aspects that can have a direct or indirect impact on product quality, safety and efficacy. Validation is essentiaily a term used to denote the additional rigor applied to the management and documentation of the each phase of the development and operational life cycle of the system. 

At the completion of supplier acceptance testing, a report will be produced, which must be accepted by the pharmaceutical manufacturer prior to shipping the system to the site. There should also be a list of actions that must be performed prior to the commencement of IQ and/or Site Acceptance Testing. 

The mixing procedure, preparation conditions and cure schedule all have a profound effect on the mechanical properties of the adhesives and, consequently, will affect their durability [20, 73]. Because of this, expeditious on-site tests should be conducted to detect possible deficiencies. A number of test methods have been proposed by the CEN/TC193/SC1/WG11) in the pre-standard Adhesives for on-site assembling or restoration of timber structures — on-site acceptance testing . This... 

Standard Proposal CEN TC193/SC1AVG11 N20 Adhesives for on-site assembling or restoration of timber structures. On-site acceptance testing. Sampling and measurement of the adhesive s cure schedule. European Committee for Standardization (CEN), Brussels (2003). 

All inspection and testing services including the vendor s factory acceptance test, system integration tests, site acceptance test... 

Carry out a factory acceptance test (FAT) and a site acceptance test (SAT), if applicable. 

Facility Review and Approval After installation, with which the vendor is extensively involved, site acceptance tests are performed. Approval is needed by the project team, including environmental, health, and safety personnel, before acceptance. The purpose of this step is to validate that the equipment performs as intended, that the quality level expected has been achieved and that environmental, health, and safety specifications have been met. 

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