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One of the difficult questions, especially for the first several validations, is what do I need to test in each of my IQ, OQ, and PQ protocols. This document explains 15 types of items that may need to be tested in one or more of the protocols for a system. In addition, it explains 11 types of testing that can be used for each dimension. While using test data is the most common type of testing, one of the other options may be better suited to your system or the context in which it is used. 13 pages
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Departments or individuals often bring applications into the company, or build their own using software like Access. Two types of problems result: the company is out of compliance because QA was not told and the system was not validated. In addition, the need to support a new system is sprung on IT. This procedure provides a computer system project proposal form and instructions. The form is used to assess if validation is required and the IT support needs before a new system is purchased or created. It also provides an early view into computer system implementations so that the organization can plan for the needed resources. 9 pages
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This procedure defines the process for the validation of off-the-shelf and configured computer systems. Deliverables are clear defined. It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485. In addition, the procedure includes practices to manage the risks associated with computer system failures. This procedure is based on the RiskVal Life Cycle described in The Computer System Risk Management and Validation Life Cycle (Paton Press, 2006). 26 pages
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This procedure defines a method for determining the system risk level and the risk levels associated with failures of a computer system to meet requirements. These analyses are the basis for risk based adjustments to the validation of computer systems. This procedure adapts the risk management standard (ISO 14971) to computer systems. A methodology for a high-level risk analysis is used to determine the risk level of a computer system. The system risk level is used to determine the validation activities and the rigor and intensity of those activities. A detailed risk evaluation is also presented for determining the risks associated with the failure of the computer system to meet specific requirements. The results of the detailed analysis are used to mitigate risks, and to determine the level of testing that ought to be done on the ability of the system to meet each requirement. This analysis can result in a large reduction in the testing that needs to be done for a validation.
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The system specification documents the technical requirements for the system and its configuration prior to installation in the test environment and conducting the IQ. This template provides instructions and examples on how to document the existing hardware and software platform and the configuration of a computer system. The system specification is used as the basis for the IQ, for detailed documentation of the system as validated, and as the blueprint for rebuilding the system in case of a need to replicate or restore the system as validated. 9 pages
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