Software regulation

Pharmaceutical and healthcare companies must then, in turn, themselves validate all the computer systems used to fulfill operations governed by GxP regulations. Software and hardware must comply with GxP requirements for manufacturing records and equipment, respectively. 

Document that the business practices are in place to operate, backup, and recover (including disaster recovery) regulated software systems. 

This chapter will give an overview on applicable regulations, software development issues, and software types encountered in the laboratory. We will address some typical situations, where the technologies described in the previous chapters can be useful to support laboratory data management. 

The Department of Defense has a long-standing standard on system safety. The standard covers methods and procedures. The Department of Defense also extends system safety practices to software development" and other procurement regulations. Software is often an integral and critical pait of aircraft, weapon, and other systems. Software can introduce hazards for those involved with a system. 

Assists with completion of form R. Provides list of synonyms and copy of regulations in software. Maintains audit (rail. 

In many cases these requirements will not apply but in some contractual situations the customer may provide products or services for use by the supplier in connection with the contract. This clause of the standard specifies requirements that apply in such situations. The product being supplied may have been produced by a competitor, by the customer, or even by your own firm under a different contract. These requirements apply to any product supplied to you by your customer and not only to what is to be incorporated into supplies. The customer may in fact supply facilities, equipment, software, or documentation for use in conjunction with the contract, which may be provided on loan, to be returned on completion of the contract or to be retained. Customer-owned tooling and returnable packaging also constitutes customer supplied product. If you use the customer s facilities, such use should be governed by the regulations imposed in the contract rather than these requirements. If the customer supplies documentation, unless it is required to be returned, you should assume it is yours to keep. Such documentation is not governed by these requirements although, if the customer requires the documents to be returned, you should assume that these requirements do apply, but apply them with discretion. 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

In 1999, to address the needs of regulators and industry to utilize CADDY fully as an evaluation tool, the CADDY group revised the strategic goal to include the examination and assessment of dossiers by regulatory authorities . This acknowledged the desire of the regulators and industry to enhance and develop the potential of CADDY as an evaluation tool. As part of this process, the retrieval software was further enhanced with the release of a 32-bit version with improved functionality and network support. 

An ESRI system can be built with small modifications of commercial spectrometers by, for example, gradient coils fixed on the poles of the spectrometer magnet, regulated direct current (DC) power supplies, and required computer connections [40,53,55]. Gradients can be applied in the three spatial dimensions, and a spectral dimension can be added by the method of stepped gradients. The spectral dimension is important when the spatial variation of ESR line shapes (as a function of sample depth) is of interest this situation will be described below, in the ESRI studies of heterophasic polymers. In most systems, the software for image reconstruction in ESRI experiments must be developed in-house. 

Temperature measurement is achieved by means of a remote IR sensor beneath the lower outer surface of the vessels. The operation limit of the IR sensor is 400 °C, but it is regulated by the software safety features to 280 °C as the operation limits of the materials used are around 300 °C. For additional control, temperature measurement in a reference vessel by means of an immersed gas-balloon thermometer is available. The operational limit of this temperature probe is 310 °C, making it suitable for reactions under extreme temperature and pressure conditions. 

The pressure is measured by means of a hydraulic system, either in one reference vessel of the 16-vessel rotor or simultaneously for all vessels of the 8-vessel rotor. The operational limit is 86 bar, sufficient for synthetic applications. In addition, a pressure rate limit is set to 3.0 bar s 1 by the control software provided. Protection against sudden pressure peaks is provided by metal safety disks incorporated into the vessel caps (safety limits of 70 bar or 120 bar, respectively) and by software regulations, depending on the rotor used and the vessel type. 

Some software packages additionally offer pressure-controlled method development, which relies on the resulting pressure as a limiting factor. The microwave power is regulated by the adjusted pressure limit, and thus there is no influence on the resulting temperature. Because the reaction temperature is the most crucial parameter for successful chemical synthesis, this program variation is used only rarely. For preliminary experiments, it is recommended that temperature programs... 

---