Computerized systems validation

Preparation of standard procedures Document review Validation glossary Critical parameter assessment GMP criticality and risk analysis Process validation methodology Computerized system validation Preparation of validation plans Preparation of project and quality plans Manufacturing data specification... 

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. 

One of the other difficulties with computerized systems validation is the range of system validation requirements for different types of systems. A simple approach is to separate the computerized systems according to a defined hierarchy. This serves to reduce the validation requirements for systems with minimal cGMP impact. A possible approach is outlined below. 

After operational release comes the most difficult part of computerized system validation — maintaining the vafidation status of the system throughout its whole operational life. Look at the challenges that will be faced when dealing with maintaining the validation of a CDS or, indeed, any system some of the types of changes that will impact an operational CDS are ... 

The validation was performed according to the Roche Computerized System Validation Policy and Guidelines. This comprised the definition of a Validation Plan, the performance of the planned activities, and the creation of a Validation Report. In addition, the project was accompanied by external consultants providing knowhow regarding the validation-specific aspects of the development, including the management and auditing of the software developer. The scope of the validation activities was defined by GMP Analysis (also known as a GMP Assessment). The system... 

Robert Fretz joined F. Hoffmann-Fa Roche more than 30 years ago as a chemical engineer. He is presently responsible for Process Automation in all chemical and galenical manufacturing sites and leads the corporate Mamrfacturing Execution systems program. Mr. Fretz has broad international experience in all levels of control/automation projects from instrumentation to the enterprise level. Many of these projects included computerized system validation. He co-authored the Hoffmann-Fa Roche corporate guideline on Process Automation Qualification. 

Systems audits in computerized systems validation (CSV) are closely related to data collection and management, statistics and pharmacovigilance, as these areas are fully dependent on operating validated and properly functioning systems. 

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). 

Many quality programs and company standards require the validation of computerized systems. Systems that generate or manipulate data must be validated to fulfill various regulatory requirements. Failure to perform adequate validation may result in a lack of confidence in the data generated and regulatory noncompliance. 

Because the validation of computerized systems is time consuming, expensive and resource intensive, many organizations are challenged to identify and prioritize which systems will be validated. There are organizational and system specific risk factors to consider in the regulated environment. Each organization must establish its own risk assessment process. 

The following considerations must be addressed when validating computerized systems ... 

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. 

Computer validation establishes documented evidence to show that the computerized system will consistently function and meet its predetermined specification and quality attributes with a high degree of assurance. Some of the parameters tested in the validation process include the following ... 

Computerized systems must be suitable for their intended purpose and be validated. All data, including electronic data, must be controlled and properly archived. 

International Society for Pharmaceutical Engineering (ISPE) (2005), GAMP (Good Automated Manufacturing Practice) Good Practice Guide Validation of Laboratory Computerized Systems, ISPE. 

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