Computer documentation systems

If you operate a computerized documentation system, your problems can be eased by the versatility of the computer. Using a database you can provide users with all kinds of information regarding the nature of the change, but be careful. The more you provide the greater the chance of error and the harder and more costly it is to maintain. 

The DS team uncovered four additional sets of documentation systems when they conducted their detailed search of programs and elements. Each documentation system had its own set of standards for recording information, distribution, review and approval and for archiving. Furthermore, the incompatibilities of the various electronic systems were exacerbated by the lack of a corporate hierarchy on preferred computer platforms. 

The use of conventional photographic systems for data acquisition, printing and archiving results of planar chromatography [401] has now largely been superseded by video documentation systems. A sample method for documentation of TLC plates has been described by a combination of computer, scanner, and digital colour thermal printer resulting in a very... 

A detailed and comprehensive system of record keeping is necessary, including, for example, worksheets, notebooks, computer output and reports, and all of these should be retained for a reasonable period of time or as required by the customer. A period of six years is often chosen. The content of reports and certificates is tightly defined, to ensure that customers receive all relevant information and that the laboratory does not make exaggerated claims about which parts of its work have been accredited. A documented system for dealing with any customer complaints and for informing customers if discrepancies in results are subsequently discovered must be available and in place. 

C. A. Floudas. OASIS Discrete-Continuous Optimization Approaches In Process Systems. Computer-Aided Systems Laboratory, Dept, of Chemical Engineering, Princeton University, 1990. Part I Documentation, Part II Input Files. 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

The development model associated with the SLC contains the software engineering tasks and associated work products necessary to support the computer system validation effort. It breaks the systems development process down into sub-periods during which discrete work products are developed. This approach leads to well-documented systems that are easier to test and maintain, and for which an organization can have confidence that the system s functions will be fulfilled with a minimum of unforeseen problems. 

After being released for use, all computer systems must be periodically reviewed until the system is no longer required for operation. The system documentation, system operation, modifications, deviations, upgrades, and the electronic record management associated with the software application must be reviewed to determine ... 

The dehnition of Performance Qualification is documented verification that the computer related system performs its functions in accordance with the computerized system specification while operating in its normal operating environment. ... 

Most basic validation activities within the cGMP pilot plant are identical to those expected in practice in a manufacturing facility. A validation master plan should be developed that addresses the design specifications and qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of all major utility systems, process equipment, and computer control systems. Installation and commissioning data should be retained as part of an engineering documentation package. A workable... 

All training must be documented and a tracking system established by using the individualized syllabus to identify initial and reinforcement training requirements. The syllabus can also be used for entry into a database or one of the commercially available computer tracking systems. 

The electronic inventory, ordering, and dispensing system is the first step in creating a computer-based system to support the areas requiring GMP documentation, and/or manually intensive operations, which provide a disproportionatelysmall return on... 

Advances in technology can facilitate the generation and transfer of patient documentation. As more pharmacies use the Internet as a means of communication, information can be transferred quickly and accurately over greater distances. Handheld computers and specialty software allow health care practitioners to document information in an electronic format that can be transformed immediately for rapid transfer to others. Reports in the literature have described methods to assess pharmacist interventions related to medication errors, the use of computer-based systems, and recently, the use of personal digital assistants (PDAs) in specific patient care areas. Many of these documentation systems tend to be individualized apphcations in which the transfer of data to other providers is not possible or quite limited. Often these systems focus on the generation of reports for workload analysis or accreditation purposes. 

Using digital cameras is also a type of photographic documentation. Nearly all advice for practical use given in Section 8.3 apply here too. However digital cameras need a computer-controlled system, and likewise when working with video cameras. Therefore most of the advice given in Section 8.4 also applies here. 

The best that can be said for all these codes, again per se, is that they keep a job market going for billing specialists called coders. The codes must be increasingly under the hood of IT. At least it is helpful to this end that the first AMA edition not only helped encourage the use of standard terms and descriptors to document procedures in the medical record but also provided the basis for a computer-oriented system to evaluate operative procedures, as well as contributed basic information for actuarial and statistical purposes. 

Upon receipt, raw materials must be placed in quarantine status and should not be used prior to acceptance. Effective quarantine can be established with suitable identifying labels or signs, and/or validated documentation systems. With increasing frequency, quarantine and documentation is widely accomplished with a computer system in lieu of a physical stock control system. This is acceptable provided that system controls are adequate to prevent use of unreleased material. 

Major equipment (e.g., reactors, storage containers) and permanently installed processing lines used during the production of an API or intermediate should be identified appropriately. This can be accomplished by identifying individual vessels, documentation, computer control systems, or alternative means. 

QA is responsible for auditing computer-related systems that are used in GxP environments in order to assess adherence to policies and procedures. The frequency of the audits should preferably be related to experiences during previous audits (in the same discipline and/or of the same or similar systems). For systems in the operational phase, special attention should be given to the change control process, including the relevant documentation and training. 

The assessment and qualification of software for computer based systems important to safety requires (as e g. in lEC 60880) a set of detailed documents according to the development steps of the software life cycle. For pre-developed software the amount of documentation available and its detail will not be sufficient in most cases. On the other hand, the pre-developed software may have been operating in many applications, and it should be possible to evaluate this operating experience to demonstrate dependability. 

This hierarchic classification of chemical reactions by their R- and BE-matrices may not only serve as a means of formal ordering of reactions and as a basis of documentation systems, but can also serve as a device in the systematic computer-assisted deductive search for new chemical reactions, by an algorithm which finds all of the mathematically and chemically fitting pairs (B, E) of BE-matrices for a representation R-matrix of an R-category. 

System suitability is guaranteed if both apparatus test and validation match their requirements. It is best performed on a routine basis and can be done very easily if the HPLC apparatus is equipped with a computer data system. Then during each run or in well-defined intervals a number of parameters are acquired plate number, resolution, precision, retention time, relative retention time (i.e. k value) and peak asymmetry-also if necessary linearity and limits of quantification. The results are followed by statistical tools, including easy-to-monitor graphical documentation with control charts. ... 

Sometimes, differences between the obtained analytical results of two inks can occur, even if the two considered inks have a common origin. These differences can be explained under certain circumstances by the storage condition of the document, prior to the analysis. For example, the age of the samples has been shown to decrease the extraction efficiency and the exposure to sunlight has been shown to degrade certain dyes. The interpretation of such differences is often left to the judgment of an experienced forensic scientist, although some computer expert systems have actually been developed. 

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