Computer software quality

The authors also are indebted to Mrs. Phyllis Reid for her skills in desktop publishing, ChemDraw, and other computer software programs, but mostly for her perseverance and good humor during the many revisions of this book. Phyllis input has improved the quality of this product and her knowledge has allowed us to put the entire manuscript into an electronic format. 

The quality of data recorded from weak, high-mass-ion beams can usually be improved by the use of signal averaging. The computer software necessary is now available from the mass spectrometer manufacturers. Although signal averaging has not yet been applied to high-mass-carbohy-... 

Computer software is used to improve spectral quality. The most widespread procedures deal with averaging and background subtraction. The averaging process is rather obvious. The intensities of ions peaks at each m/z, recorded along the analyte chromatographic peak profile, are summed in several spectra and divided by the number of spectra used. Averaging minimizes, for example, spectral skewing problems. 

Unfortunately, a combination of poor quality control in the computer software industry, generally inadequate user... 

Dunn R, Ullman R. Quality Assurance for Computer Software. New York McGraw-Hill, 1982. 

ISO 9000-3 1997, Quality Management and Quality Assurance Standards — Part 3 Guidelines for the Application of ISO 9001 1994 to the Development, Supply, Installation, and Maintenance of Computer Software. 

The computer system supplier s detailed project and quality plan incorporating the procedures for software quality assurance should be one of the first contracted deliverables, if not already submitted as part of the quotation or requested during precontract discussions. 

The software design specification is written by the system supplier and must identify how the supplier intends to provide system software under a software quality assurance plan. The design specification must describe the subsystem software that will make up the computer system software and subsystem interfaces to implement the aims set out in the FDS. Each subsystem should be traceable back to statements in the FDS. 

In many instances operating system software has already been developed and is offered as a fundamental part of the computer system ready for application software to be developed or configured. In such cases it is prudent to establish the existence of the respective software quality assurance plans and procedures and the design, development, and testing records. Identification and examination of this documentation can be conducted and recorded as part of the supplier audit. (See Sec. VI.)... 

The integrity of the information managed by a computer system is protected by procedural controls, rather than the technology used to apply the controls. Procedural controls comprise any measures taken to provide appropriate instructions for each aspect of system development, operations, calibration, and validation. For computer systems, procedural controls address all aspects of software engineering, software quality assurance, and operation. In a regulated environment, these controls are fundamental to the operation of the computer system. 

In practice, this process ensures that the system (computer hardware, computer software, controlled equipment, interfaces, operating environment, operators, equipment, procedures, and so on), in its normal operating environment, produces acceptable quality product and that sufficient documentary evidence exists to demonstrate this assessment. 

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented. 

The objective of the book series Developments in Environmental Science is to facilitate the publication of scholarly works that address any of the described topics, as well as those that are related. In addition to edited or single and multi-authored books, the series also considers conference proceedings and paperback computer-software packages for publication. The emphasis of the series is on the importance of the subject topic, the scientific and technical quality of the content and timeliness of the work. 

In order to produce defensible data of known quality, in addition to method-specific SOPs, the laboratory should develop a Software QA Manual, which describes activities related to data generation, reduction, and transfer with modern tools of data management, and the policies and procedures for modification and use of computer software. 

Part 11 regarding validation of computer software and hardware. Any software used to operate process equipment, generate electronic records, track and transmit laboratory data, automate quality systems, operate critical utilities or software that is itself a medical device must be validated to ensure accuracy, reliability, consistency, and the ability to discern invalid or altered records. Where off-the-shelf software is used for any of the above cGMP activities, it must also be validated for its intended use. For additional information on compliance issues related to computer hardware and software validation refer to Chap. 7 of this book. 

Computer system operating environment System description Software quality assurance Built-in entry and processing checks Testing... 

Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a hit list of top nonconforming components contains 16 record counts for part number 8601618 DC converter failures compared to 18 record counts for part number 860168 DC converter failures in the dbase database. The spreadsheet is used for management review of component suppliers for all components. 

ISO 9000-3 1997 Quality management and quality assurance standards Part 3. Guidelines for the application of ISO 9001 1994 to the development, supply, installation and maintenance of computer software. BSI 1998. 

The equipment hardware and computer software should be developed and validated according to a documented procedure, e.g., according to a product life cycle. The vendor should have a documented and certified quality system, e.g., ISO 9001. Quality must be designed and programmed into software prior to, and during, its development phases by following written develop-... 

The majority of analytical processes in regulated environments rely on computer control for automation and for data capture and evaluation. It is therefore important that not only is the instrument validated but also the computer and operational software. Validation of software is more complex than hardware validation, especially since source codes for many analytical processes can run to several hundred thousand lines. In this case the responsibility for validation still remains with the user, who should have the assurance that the computer system has been validated during and at the end of the DQ phase. The vendor should provide documentation with a declaration that the software has been validated to these or similar guidelines to ensure software quality standards. Further, the vendor should provide access to the source codes if required by the user. 

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