Validation computerized equipment

Equipment used to generate, measure, or assess data should undergo a validation process to ensure that such equipment is of appropriate design and adequate capacity and will consistently function as intended. Examples of such equipment include scales balances analytical equipment (HPLC, GC, etc.) hematology, blood chemistry, and urine analyzers computerized equipment for the direct capture of data and computers for the statistical analysis of data. Because the data generated, measured, or assessed by such equipment are the essence of a nonclinical laboratory study, the proper functioning of such equipment is essential to valid study results. 

To describe validation guideline for the computerized equipment to meet the installation qualification... 

To describe the validation guideline for performance qualification of computerized equipment to ensure that it meets the performance requirement... 

Equipment must be suitable, maintained and, where appropriate, calibrated. Computer systems used to generate, store and retrieve data should be of appropriate design and capacity, validated and suitably located. If there are computerized systems used to control environmental factors, then these also require the same consideration. Issues relating to computerized systems are covered in Section 9.2.1.8. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

A pharmaceutical company has to adopt a proactive policy of validation for its facilities, production processes, production equipment and support systems, analytical methods, and computerized systems. A properly validated approach will help to assure drug product quality, optimize the processes, and reduce manufacturing cost. 

Huber has published two validation reference books for the analytical laboratory [7,8]. The first one covers all validation aspects of an analytical laboratory, including equipment, analytical methods, reference compounds, and personnel qualification. The second covers the validation of computerized and networked systems. 

In the case of a computer system applied to a live manufacturing process and integral with plant equipment and the process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerized operation are sometimes combined. 

Narrowly focused, the tenets of 21 CFR 11 are indisputable that firms must establish and maintain the integrity of their electronic information. What has been lost is the clear indication of which electronic information the requirements apply to. In my opinion, data generated outside a computerized system, that are manipulated by that system and are ultimately available in hard copy should not be subject to this ruling. Validation of the computerized system should be more than sufficient to establish that the final documentation accurately reflects the input information. In that instance, the computerized system is little more than a tool whose functionality can be readily established, yet firms are endeavoring to assure 21 CFR 11 compliance for numerous systems in which the computer is little more than an adjunct to the cGMP activity and corresponding hard copy. Batch record preparation, SOP and test method archives, and many process equipment control systems are examples of systems in which requirements for 21 CFR 11 compliance appear excessive. A system that processes or communicates data or records and subsequently retains and stores hard copies should not be subject to the 21 CFR 11 requirements. Far too many systems are being unnecessarily held to the very restrictive portions of 21 CFR 11. Electronic record retention as defined in 21 CFR 11 has its place, but not necessarily in every computerized system used within the industry. 

Table 19.1 lists in chronological order the steps that a user of computerized analytical equipment can follow for the entire validation process. 

These guidehnes aim to give guidance to inspectors of pharmaceutical manufacturing facilities and manufacturers of pharmaceutical products on the requirements for validation. The main part covers the general principles of validation and qualification. In addition to the main part, appendices on validation and qualification (e.g. cleaning, computer and computerized systems, equipment, utilities and systems, and analytical methods) are included. 

Based on the lecture notes of A. Bmtsche on the subject of Calibration and Qualification of Analytical Equipment in Pharmaceutical Quality Control , the four concepts of equipment qualification in the field of analysis are listed here and elucidated in the form of headings [148]. The subject is discussed in more detail by L. Huber in the book Validation of Computerized Analytical Systems [149],... 

During the OQ process, documented evidence is given that all parts of the plant and equipment work within their specifications and process parameters are within the acceptance criteria. Process controls that are part of the equipment (e.g., PLC [programmable logic controller]) will be qualified during the OQ process. Computerized process controls (i.e., for complex processes) should be qualified in the Computer Validation (CV) process. To ensure that the systems tested during OQ are doing what they are believed to do, a simulation of normal production conditions must be done. 

Computerized systems are specialized pieces of equipment which must meet all the requirements as other pieces of equipment. A logical application of the cGMPs should be applied in conjunction with special requirements such as 211 CFR Part 11. Validation is required, however, the depth and scope of the validation is dependent of the computerized application. The degree of validation may be dependent on the source of the computer system commercially available software requires little validation, while software developed for a specific manufacturing step will require extensive validation. Once validated, the computer system must be maintained in a state of control. After all, it is still a piece of equipment, albeit highly specialized. 

Sphon JA (1978), J. Assoc. Official Anal. Chemists 61, 1247. SQA (Society for Quality Assurance, 2000), Validation cf Computerized laboratory Instruments and Equipment, SQA... 

The qualification exercise included parts of computer and software validation as well as equipment qualification. To ensure a coherent qualification it was determined that portions of the computer and software validation would be subject to an interim approval. This would allow specified computerized systems validation tasks to be completed prior to making equipment operational, and subsequently performance qualification (6,7). 

SECTION A SECTION B SECTION C Computer Equipment Maintenance Logs Computer Software Validation and Verification Computerized Tracking Logs... 

Furthermore, the level of preventive maintenance activity needs to be driven by the importance of the equipment to the process and the desired level of reliability. In modern complex systems, computerized preventive maintenance systems are used to accomplish these objectives in plants of most sizes. A preventive maintenance system also needs to be dynamic for example, there should be some mechanism for review of preventive tasking to ensure that the tasks are still valid and to see if any task can be replaced with a predictive task. ... 

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