COMPUTER VALIDATION.
Computer System Validation Rationale.
Validation Online's GMP compliant computer validation (CSV) documentation and protocols start with our unique three level User Requirements Specification document (URS). Since most documents, post the URS, will either fully, or partially, base their contents on the URS, it is essential that this document clearly, concisely and in a manner that is testable, specifies the exact requirements of the end user. It is also essential that these exact testable requirements remain attributable through the development of the Functional Specification (FS) Design Specification (DS) to the actual lines or groups of lines of code that enable them. The Computer System Validation Master Plan - VMP, must be specific about this and all cGMP requirements, and instruct all personnel involved in the computer validation program, of the importance of maintaining this traceability through the Installation Qualification - IQ - Operational Qualification - OQ - Performance Qualification - PQ. Traceabilty of URS functionality, to lines of code is an essential element in computer system validation (CSV). Once this traceability is establish future maintenance and modification of software is made much simpler and more manageable. There is much discussion throughout the industry regarding the use of automatic testing programs. A recent guidance document contained these details of current thinking among the regulators. Proposals for device manufacturers would require manufacturers that use automated quality control measurement (this could include almost any automation system used within a medical device or in the production of a controlled product) equipment to 1) Determine the validity of the automated test and determine whether the method will produce results directly applicable to the device being tested; 2) Insure that QC test devices are compatible with each other; 3) Verify computer programs used and to document the testing of the program, and 4) Have a routine calibration program with appropriate records. Computer system validation and GAMP.
The guide-lines laid out in Good Automated Manufacturing Practices GAMP 5, for the computer validation of automated systems including automatic computerized manufacturing equipment, control systems, automated laboratory systems, manufacturing execution systems and computers running laboratory or database systems. These computerized system generally consists of the hardware, software and network components, together with all control functions and GAMP 5 is a useful guide in scoping your computer validation activities for such systems. It must be remembered at all times that GAMP is collective ideas from the industry and does try to be all things to all people. The Importance of Traceability in Validation.There must be correlation between the elements of the various phase deliverables / validation documents; for example, the correlation between the functional requirements and the test cases that challenge them. This correlation can be demonstrated by using a traceability matrix. This matrix facilitates maintenance of the cross-referencing between requirements, the corresponding design elements, and the test cases that challenge them, as well as between the design and the code. During the design phase, the traceability matrix can help facilitate design review since correlation of requirements to design can unearth mismatches and omissions. Additionally, completing the traceability matrix can help ensure adequate test coverage in the testing phase. In the system’s maintenance phase, if any of the requirements or design elements need to be updated due to a change, it is easy to determine what other documents are affected and/or what tests must be re-executed once the change takes place. In short, the usefulness of the traceability matrix cannot be overstated. Validation Tests and Interpretations.Dynamic Testing.Dynamic testing verifies the execution flow of software, including decision paths , inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software. Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible. Static Analysis.Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods . One such method is static analysis. This somewhat new method largely automates the software verification process. The technique attempts to identify errors in the code, but does not necessarily prove their absence. Static analysis is used to identify potential and actual defects in source code. Abstract Interpretation Verification.A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the pharmaceutical regulators. Revalidation Scheduled.There is no regulatory requirement to re-validate a process as long as that process operates in a state of GMP control and no changes have been made to the process or output product, the process does not have to be revalidated. Whether the process is operating in a state of control is determined by analyzing day-to-day process control data and any finished device testing data for conformance with specifications and for variability. Revalidation on Relocation.When equipment is moved to a new location, installation and operation should be re-qualified. By comparing data from the original installation and operation qualification (IQ and OQ) and the re-qualification , the manufacturer can determine whether there have been any changes in equipment performance as a result of the move. Changes in equipment performance should be evaluated to determine whether it is necessary to revalidate the process. Revalidation Justification.Part 820.75 of the QS regulation requires that validated processes be monitored and controlled so that when changes or process deviations occur, a manufacturer will know to review and evaluate the process and perform revalidation when appropriate. Procurement and Computer System Validation.Recent research has highlighted that in the pharmaceutical and bio-medical industry, thirty two percent of all equipment procurements are unsatisfactory. The major problem has been identified as companies not specifying in sufficient detail and or accuracy, what their actual needs are. The lack of a quality company approved User Requirements Specification (URS) , leads to many companies having to resort to otherwise un-necessary and costly retrospective actions in modifying the equipment or producing unspecified documentation or engineering drawings, post procurement. These extraneous GMP requirements often cost more than the equipment.
SOP for Computer Equipment Validation.The SOP for Computer Validation continues to be an extremely popular document. This computer validation document leads you through the validation process, from the URS to the final P2Q. Purchase your copy now at Special Price of $22.00. Combined IQ / OQ Protocol. Combined IQ/OQ/PQ Protocol This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software. The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS . Validation Risk Assessment. Now click here for further details on this SOP covering Validation Risk Assessment and 21 CFR Part 11 application. Validation Risk Assessment (Issue10.) -- $125.00 VIEW COMPUTER VALIDATION DOCUMENTS AVAILABLE. CLICK HERE TO VIEW DOCUMENT PACKAGES THAT ARE AVAILABLE. Computer System Validation User Requirements.
The Software User Requirements Specification (SURS) document should contain a written definition of the software functions. This must define the functionallity that the end user requires from the system. These requirements must be set out in a manner that is none ambiguous, clear and easy to understand. Further to this the requirements must be grouped or worded in a manner that renders them testable and verifiable. It is not possible for computer validation to be properly executed without having predetermined and documented software strong requirements to validate against. Typical software requirements specify the following: a) All software system inputs ; b) All software system outputs; c) All functions that the software system will perform; d) All performance requirements that the software will meet, (e.g., data throughput, reliability, and timing); e) The definition of all external and user interfaces, as well as any internal software-to-system interfaces; f) How users will interact with the system; g) What constitutes an error and how errors should be handled ; h) Required response times; i) The intended operating environment for the software, if this is a design constraint (e.g., hardware platform, operating system); j) All ranges, limits, defaults, and specific values that the software will accept; k) All safety related requirements , specifications, features, or functions that will be implemented in software . l) The degree to which the manufacturer is dependent upon that software or equipment for production of a their product. GAMP 5 Software Categories.
Computer System Validation Sope (CSV).
Computer Validation (CSV), must include the under listed tests / inspections, but is not limited to them alone. The inclusion of the 21 CFR Part 11, Applicability is deliberate. This allows the executor of the computer validation (CSV) protocols to clear this requirement by cross referencing the risk assessment reference number and stating Yes or No, to the applicability question. The regulator now does not have to search further, he can see that requirements for 21 CFR Part 11 (and the latest official guidelines) have been considered and judged. a) Introduction. b) Scope. c) Software Verification. d) Hardware Verification. e) Testing Personnel CV & Details Sheet. f) 21 21 CFR Applicability. g) Backup Software Storage Security. h) Menu Navigation. i) Operating Environment. j) System Security (physical/access to data). k) Power Failure Recovery. l) Test Alarms. m) System Stress Testing / Boundary Test. n) Interface Signals. o) Menu Navigation. p) 21 CFR Part 11 Conformance. q) Functionality tests. There is a degree of flexibility in deciding precisely at what stage in the validation process some of these test and inspections are executed. Where this flexibility exists the choice between the IQ or OQ or PQ, must be rationalized and documented in the Validation Master Plan (VMP) or the Validation Plan (VP).
Computerized System Design & Testing
In this diagram it can readily be seen that the URS, along with the VMP and the applicable company Practices and Procedure documents, come together and are used to produce a Project Quality Plan (PQP). This can be vendor or end user produced. This PQP must document the scope and intensity of the QA and QC involvement in the design, build, test, commissioning and validation of the proposed system. The PQP will also specify the range of documentation that must be produced to enable the regulatory compliant introduction and maintenance of the system into cGMP use. Once this documentation is produced, a complete package of validation documents will be raised consisting of the DQ, IQ, OQ and PQ. The execution of these protocols must verify that all the end user's requirements as specified in the URS are fully complied with. Computer validation (CSV) activities are grouped in two colours (orange and blue). The blue colour is the requirement for standard computer validation (CSV).
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