Computer validation, Good

The second tier of GAMP 4 consists of a number of modules each presenting guidance for a practical implementation of computer validation (good practice modules). Modules will include global systems validation (MRP II, DIMS, etc.), process control system validation (including GMA/NAMUR), validating analytical laboratory systems, calibration, and compliant infrastructure. 

Stokes, T. et al.. Good Computer Validation Practices Common Sense Implementation, Interpharm Press, Inc., Buffalo Grove, IL, 1994. 

Proper functioning and performance of equipment and computer systems play a major role in obtaining consistency, reliability, and accuracy of analytical data. Therefore, equipment qualification (EQ) and computer system validation (CSV) should be part of any good analytical practice. It is also requested by FDA regulations through the overall requirement that equipment must be suitable for its intended use. While in the past, equipment qualification and computer validation focused on equipment hardware and stand-alone computer systems, recently the focus has been on network infrastructure, networked systems, and on the security, authenticity, and integrity of data acquired and evaluated by computer systems. 

The Good Automated Manufacturing Practices (GAMP) Forum has developed guidelines for computer validation [5] and a draft guidance on quality assurance of information technology (IT) infrastructure [6]. 

The control system of the freeze-drying unit provides control, monitoring and documentation of the process. Such a system must be reliable and comply with GM P and GAMP (Good Automation Manufacturing Practice) demands with respect to computer validation. It should be SCADA (Supervisory Control and Data Acquisition) compatible. A possible hardware architecture is shown in Figure 2.55.1. 

Wingate, G. A. S. (2000), Corporate Computer Systems Validation Good IT Practice for the Pharmaceutical Industry, Interpharm Press, Buffalo Grove, IL. 

Stokes, T. (1994), The Role of Senior Management in Computer Systems Validation, in Good Computer Validation Practices Common Sense Implementation (edited by T. Stokes, R.C. Branning, K.G. Chapman, H. Hambloch, and A.J. Trill), Interpharm Press, Buffalo Grove, IL. 

AU this makes good business sense and should eliminate the need for corrective work because of misunderstood validation requirements. Similar harmonization would appear to be occurring on the topics of electronic records and electronic signatures. Mutual Recognition Agreements (MRAs) between various national regulatory authorities such as the FDA, MHRA, TGA, and MHLW and the work of the International Conference for Harmonization (ICH) offer an opportunity to formally consolidate harmonized computer validation requirements. 

Setting up proper risk assessment procedures and applying them to the change control process markedly reduces the efforts required to keep systems in a validated state. Harmonization, standardization and efficiency can be increased by appointing a company computer validation committee per site and/or at a corporate level. Good cooperation between QA and IT is a prerequisite for keeping systems validated. 

This combination is similar to the definition by Dr. Heinrich Hambloch in chapter 8 of Good Computer Validation Practices [4]. 

Mr. de Jong is currently ITQA manager and is responsible for the quality system of the IT department of Solvay Pharmaceuticals in The Netherlands. He started his career in IT in 1978 as system specialist for Honeywell Bull, and joined Solvay in 1985 as a system analyst for the R D (research and development) automation center, especially within the Good Laboratory Practice (GLP) environment. He was involved in the translation of GxP guidelines to the IT world, in system development as well as system management. He is also member of Solvay s Computer Validation Committee. 

Ms. Koelman is currently global GLP/GCP (Good Clinical Practice) QA director within Solvay Pharmaceuticals. Previously, she was head of the GLP Quality Assurance Unit of Solvay Pharmaceuticals. She has been the leader of the project team that set up the local computer validation policy of Solvay Pharmaceuticals B.V. and also leader of the team responsible for implementing this policy in the company over a period of two years, before it was handed over to a permanent Computer Validation Committee. She has been involved in a number of validation projects of different types of systems, ranging from simple equipment to complex custom-built or highly customized applications. 

Validating corporate computer systems good IT practice for pharmaceutical manufacturers / editor, Guy Wingate, p. cm. 

Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers provides valuable reference material for pharmaceutical manufacturers, suppliers and regulators on Good IT Practice, validation principles for corporate computer systems and case studies on Electronic Document Management Systems (EDMSs), Enterprise Asset Management (EAM) systems, LlMSs and MRP 11 systems. 

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