Meanwhile, most Pharmaceutical professionals have a detailed understanding of the process's process, and understands little of the process of validating computerized systems.
The problem is, of course, that microprocessors are now being built around the entire pharmacy. These include stock control, integrated production, environmental monitoring, laboratory analysis, vision testing systems, and even recorders and temperature controllers. To ensure the integrity of the process, each of these devices must be properly checked as part of a larger authentication process.
Simply having the concept of computers and software systems is not enough, it's not only necessary to fully understand the process, but also the certified equipment. It can be difficult because those who are best aware of the equipment are the manufacturers, but often they can learn more or less about ratification.
This article applies only to one of the important features of computer systems validation. Lending System Documentation (FMS).
FMSs are commonly used for purity and adjacent areas. Such systems can not be used for the classification of space or objects. they carry out only monitoring functions that indicate that the environment in the controlled area has been maintained within the defined limits. However, the FDA and other regulatory authorities recognize that the recycling period for FMS users may be prolonged (see ISO 14644-2).
FMS usually includes several monitoring devices: temperature, humidity and pressure sensors or switches, as well as speed sensors and particle counters. It can also include digital equipment for monitoring vacuum pumps or vehicle driving states and digital output signals / signal indicators, such as lights or sirens and other control functions.
Documentation:
The most important document for the proposed system is User Requirement Specification (URS). Without this document, it is not possible to validate the system. This is a definite surprise, but ratification is determined by the process of generating no more than a documented evidence to ensure that the system consistently performs its function.
URS mentions the required system functions. It should not be long, but it should indicate that the system should perform the functions. Despite his name, there is no need for URS to emerge. the provider may issue a document, but the URS must be authorized by the user. Its purpose is to ensure that both the user and the provider understand what is required. The document must have the required shots , like-places , and would like to make it better . The customer must provide all the mandatory reserves , but do not necessarily want to know some of the things and good things .
All other URS authentication papers and stages follow. This progress is usually displayed on this article described the practical validity of the model (V- model) form . These documents and processes are presented as Life Cycle Documents.
After URS, the next step causes the provider to have a functional feature (FS). This document, which should address all users, should have the desire to have it and it will be best to set up before installing. If certain requirements can not be met, as inevitably would be the case, the discrepancies should be listed within the FS. Very often the requirement may be fulfilled in another way. Sometimes the demand is not even important. The FS should include a cross-reference matrix so that the user can easily see how the supplier offers each claim.
At this stage, the user must request from the provider to produce a Quality Plan (QP) or Master Validation Plan (MVP) , where the provider determines how the program will control who will be responsible for each stage of the project and on time scale at each project stage.
The system has been fully clarified and agreed upon in the FS, the design of the system should be defined within the framework of the General Design Specification (DS) . This clarification should be a high-level document that clearly outlines what materials are required and how mechanical and programmatic points should be connected to meet the functional adjustment requirements.
Design Qualification (DQ) is associated with URS, FS, and DS. It is necessary to verify that all the items listed in the previous document are addressed (not addressed , but addressed ). DQ prevents the claim.
Next Module Specifications (MS) . The "module" can be a control panel or program. It does not matter. If something needs to be built or programmed, the module requirements must be clearly defined.
Test stage:
The ultimate operation of the first part of the V-model is actually building panels, ordering particle counters and related equipment or equipment, and then writing and / or configuring the software. But since this V model shows, this is only half of the program. When all the equipment has been built or shipped on a provider's site and its written and configured programs, the system must be enabled and tested to ensure that all the work is done.
Module testing should be developed against the module specifications to ensure that each module functions. In the case of a console, it is important to ask whether all the equipment is installed, whether it is properly wired and whether it meets all the relevant criteria.
By software, it is wider for conventional modular features than the user's requirements. This allows modules to be restarted in other projects. But it is important to be sure that the module, as mentioned, acts as declared. Again, the clarification of the module is used to process a number of tests that confirm that all functions have been completed and acted as specified. This set of tests should include software stress testing to ensure that normal error conditions are correct.
After the modular test system should be consolidated, and then used for the application of the completed system tests in another package ( Software Quality, SQ ), to ensure that it functions as a DS- in detail within. Some companies do this on the site, but if there is one problem, they will bring the added costs of staff to the site, and usually design engineers are out of place. Simulators should be used when the system installation site is difficult or impossible.
Users can note that they want to make a factory admission exam (FAT) . This is very common with the delivery of cars, but not least with the FMS. The purpose of FAT is to see how the system operates before it can be used to reach it (this is also usually the payment stage). The best way to perform FAT is to use the System Deployment Qualification (IQ) , Operating Qualification (OQ) and Manufacturing Qualification (PQ) documents and reference the tests that are used simulators have been applied as applicable or the test is feasible. Again, if there are any trial failures, it is much simpler and more expensive to solve the problems on the vendor's website than on the user.
Or, after SQ or FAT, the system is installed, installed, and delivered. After handing over the system, I strongly recommend that the user be prepared before and after the final validation tests (IQ / OQ / PQ). There are two factors for that. Inevitably small differences will be between what is required by the URS and the operators actually use the system. Training before IQ / OQ / PQ allows for these small differences to change under control, while other documents are revised. Additionally, within the IQ framework, a test should be made that users have been trained.
From now on, any changes to the system should be taken very seriously. Change control should be applied. (Actually, change control should be applied before this phase as any change may have an impact on correction documents and previous attempts, in the ultimate case, one seemingly innocent change can actually lead to failure because it can be "erroneous" is presented):
Supply modular tests and SQ tests can be quite informal. By that I mean that the tests should not be encouraging. This allows engineers to really try the system without spending too much time producing test documents. The purpose of the test, however, must be clear and must be based on evidence that the test has been performed. Tests during IQ / OQ / PQ should be very encouraging for the user to experiment. Test evidence should be more than a check box label. Physical test evidence (print, screenshots, photos, etc.) should be provided. This is mainly a test evidence that will be submitted to the MCA or the FDA Inspector showing that the function is carried out as needed.
The installation qualification (IQ) during the test may be different. IQ tests should confirm that all the products listed in the functional specification are shipped and are the correct type. FS can declare that 0-100 Pa differential pressure switches should be used with accuracy of 1%. Is it there
The IQ test should test and confirm that:
- All the installed sites are presented or better.
- All support systems are installed (manuals, technical manuals, system diagrams, etc.).
- All the tools have been checked and the verification is still in effect.
- All software systems (CDs) are available and have been properly filed.
- At this point, the footprint (system files, dates, and dimensions) has been taken.
The system must be able to be re-certified later. To ensure IQ testing, all inputs / outputs of the data collection unit are operational and must be implemented to ensure that all switches, lights, switches and their functions are performed. These tests can be considered as practical tests. some companies include such tests as Operational Qualification (OQ) test documentation. When it has been documented that the system has been supplied within FS, OQ may begin. OQ's goal is to verify that the system is functioning (as described in FS). Experiments must show that all the products listed in FS have been tested, but tests should be more than that, especially for FMS, or in any case with any data collection system. There should be clear tests that show the correct collection of data and these manipulations are used correctly, and these data are stored correctly and can be correct.
Tests to verify the size of the colors and fonts on the systems are accurate, but they add little to ensure that.
The final part of the test is performance test (PQ) . Usually, PQ tests are designed to ensure that the machine operates at the right rates, with the user product. However, object monitoring systems are not applied, and in many cases PQ is not implemented. In areas where previously used enterprise methods were controlled by the object (with moving particle calculators, for example, and other tools), the comparison of the mobile particle counters and the FMS particle counters is performed. This can often result in test failures due to differences in particle optics, electronics, and test methods. When this happens, I strongly advise that the particle counters products are contacted for guidance.
Other documents should also be set up for complete authentication. The baseline is the Project Completion Report (PCR) or the Ratification Exam Report (VRR) . The Project Validation Summary, VRR must submit all the documentation that has been generated with the test results and must include a clear statement for system exploitation.
Vendor audits also apply to users. They should be performed prior to placing the order in order to ensure that the supplier is a good quality system and can provide the necessary system.
21 CFR, Part 11 Regulation
21 CFR, FDA Regulation 11 deals with electronic signatures and electronic records. Most environmental monitoring software systems do not use electronic signatures to confirm the batch release information. However, all monitoring software systems have electronic data, so the regulations apply. In general, object monitoring systems are closed systems that are accessible by system and system data tracking. In this case, although the provision of electronic signatures is not applicable, subparagraph B is applicable to this paragraph 11.10.
Part B, paragraph 11.10, in particular, specifies the following:
- The system must be validated.
- The system should be able to create accurate, complete data copies.
- Data records should be protected.
- System access must be limited.
- Audit trails should be used for all data.
- If possible, the operating system protection methods should be used.
- Authorization checks should be applied.
- Data entry / assembly checking should be applied.
- Users should be trained.
- Standard operating procedures (SOPs) should be on-site.
- Documents should be monitored.
- Change control should be applied.
Tests should be included within IQ and OQ to find out that the system actually performs the above requirements. Many should already be part of any trial, but some are not the supplier's scope.
Here are some simple ways to make the process easier and ensure that the system passes validation.
- Be sure that all switches, particle counters and other devices are suitable for the purpose and have valid validation certificates.
- Do not use complex data collection devices, such as programmable logic controllers (PLCs) if they are not required. If PLC is used then it will have a program and additional validation will be required.
- When designing the system, consider how to check things and how to make documented evidence.
- Think of the requirements of Part C of 21 CFR and how they will be fulfilled.
- Use qualified people and reputable providers.
- Follow the steps outlined in this V-model scheme.
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