Computerized systems, inspection

After the preparatory procedures and before blanching, or immediately after blanching and after cooling and draining depending on the product, thorough inspections are essential to eliminate unwanted material from the line. If done manually, such inspections either reduce the line output or require a lot of manpower. There are now computerized inspection systems... 

Wind Power Plant A group of wind turbines interconnected to a common utility system through a system of transformers, distribution lines and (usually) one substation. Operation, control and maintenance functions are often centralized through a network of computerized monitoring systems, supplemented by visual inspection. This is a term commonly used in the United States. In Europe, it is called a generating station. 

Almost everyone is now utilizing the computer for statistical analysis of sensory data. Some laboratories also are using computers to gather the data as well (18). A computerized sensory system would benefit most laboratories by freeing workers from laborious data entry and analysis. Also, it would allow for a more thorough analysis of the data. It should not replace inspection of the raw data by the sensory scientist, but allow this to occur more easily. 

Failure to establish and implement adequate computer security to assure data integrity in that during this inspection it was observed that an employee was found to have utilized another person s computer access to enter data into the XXXX computerized record system. [21 CFR 211.68(b)] Review 21 CFR Part 11 for regulations pertaiiung to the... 

Tetzlagg, R.F. (1992), GMP Documentation Requirements for Automated Systems Part IB, FDA Inspections of Computerized Laboratory Systems, Pharm. Tech. (May) 71-82. 

Up-to-day reliability requirements as applied to NPP strength maintenance govern development of new generation of computerized systems for in-service inspection. These systems in parallel with capabilities of ordinary ultrasonic techniques allow to reconstruct high resolution image of inner flaw and increase available amount of information. 

A National Transportation Safety Board Railroad Accident Report (1973) describes the accident which occurred in a shunting yard in East St. Louis, Illinois. Arriving cars are classified in the yard, then delivered to outbound carriers. On arrival, cars are inspected. They are then pushed up a mound, uncoupled, and allowed to roll down a descending grade onto one of the classification tracks. This process is called humping. Cars are directed and controlled by a computerized switching and speed-control system. 

Computerized systems should be included in facility inspections of field sites and analytical laboratories. Items discussed previously, such as computer maintenance records and personnel training records, can be reviewed more thoroughly during the facility inspection. 

Guide to Inspection of Computerized Systems in Drug Processing, found at http //www.fda.gov/ora/inspect ref/igs/csd.html. 

As one of its Guides to Inspections, the FDA introduced Guide to Inspections. Validation of Cleaning Processes in 1993 [9], This broadened the area of validation considerably by focusing on fields other than the manufacturing process itself. As time showed, further additions, such as Test Method Validation and Computerized Systems Validation, developed as validation topics on their own. The regulations and literature for these specialized fields will not be discussed here. The reader is invited to consult the relevant chapters of this book where the information is available. 

The proliferation of computers in the production of pharmaceuticals resulted in the U.S. Food and Drug Administration (FDA) publishing the "Guide to Inspection of Computerized Systems in Drug Processing" in 1983. FDA Inspectors have been using this guideline for the past three years to cite firms for their failure to validate their computer systems. 

FDA, Guide to Inspection of Computerized Systems in the Food Processing Industry, Office of Regulatory Affairs (ORA), Division of Emergency and Investigational Operations (DEIO) and the Center for Food Safety and Applied Nutrition (CFSAN), http //www.fda.gov/ora/nspect ref/igs/foodcomp.html. 

FDA (1995), Glossary of Computerized System and Software Development Terminology, August. FDA (1998), Guideline to Inspections of Computerized Systems Used in Food Processing Industry, October. 

Trill, A.J. (1993), Computerized Systems and GxP — A UK Perspective Part 1 Background, Standards and Methods Part 2 Inspection Findings Part 3 Best Practices and Topical Issues, Pharmaceutical Technology International, 5 (2) 12-26, 5 (3) 49-63, 5 (5) 17-30. 

Pharmaceutical Inspection Co-operation Scheme (2003), Good Practices for Computerized Systems in Regulated GxP Environments, Pharmaceutical Inspection Convention, PI 011-1, Geneva, August. OECD (1995), GLP Consensus Document The Application of GLP Principles to Computerized... 

FDA (1998), Guideline to Inspections of Computerized Systems Used in Food Processing Industry, October. 

Anthony J. Trill joined the Medicines Inspectorate in 1984 and since 1988 has had a leadership responsibility for MHRA GMP standards and inspection guidance relating to computerized systems. He also carries out routine regional GMP inspection work, both in the U.K. and abroad. Before joining the MHRA, he worked for more than 18 years for three multinational pharmaceutical companies in R D, new product and process development, production, QA, and technical services... 

In addition to the European GMP Guide, Pharmaceutical Inspections Convention Scheme (PIC/S) has an impact on pharmaceutical companies situated mainly in Europe. The Pharmaceutical Inspections Convention Scheme tries to harmonize inspections across the member countries. Therefore, even if the documents are not legally binding, they will be used by inspectors to measure companies against. This organization published in 2003 a new guidance document for the life-cycle management of computerized systems. 

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