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Computer System Validation – For a consistent and reliable computerized system

Computer system validation, popularly known as CSV is the process of procuring documented evidence that ensures the consistent performance of a computerised system as required by the operational environment. This is mainly required for industries with high integrity like the pharmaceutical industry and the medical manufacturing industry. CSV has rigid validation and verification of the data transferred through the software of a company. CSV ensures that the ultimate computer software which can be procured through different measures, work correctly without any side effects meeting the auditing needs, safely, reliably and securely.

FDA Computer system validation guidance reduces the cost and time of the software implementation. It efficiently creates a valid documentation by a risk based approach which eventually increases the productivity and individual work force productivity of the company.

Computer system validation training is necessary for a full proof documentation and compliance of computer system validation. Proper training is required in the area in order to avoid inadequacies during the time of documentation. Without adequate planning and training, computer system validation can encounter several problems, eventually leading to the failure of the process.

Computer system validation webinars are conducted by many to assist firms to know about the validation requirements. These are cost effective methods with proper risk analysis techniques. They find practical solutions to integrate quality of computerised systems and electronic data for everyday business operations. These webinars almost cover all aspects of computerised systems used in the kind of industry.

Computer system validation requirements mainly help the company in finding out the type of system needed, the selection of a vendor and how to audit a vendor. It makes the project easier, pay less and still get a high quality system. The software validation require development of a validation plan, utilisation of standard operating procedures or SOPs, documented training on SOPs, development of detailed specifications, and development of test plan and test scripts.

The FDA computer system validation is mainly done for spread sheets, production equipment, data migration, user requirement, design specifications, compiling the validation plan, qualification needs, preparing validation summary, validation planning and project management, software testing, auditing computer systems and software vendors, and assessing the impact of software changes.

Computer system validation regulation is required by both FDA and the ISO. It ensures that the process of a company is subjected to such scrutiny that the end result is undoubtedly guaranteed.

Computer system validation compliance is mandatory for the computerised system of any industry to meet its purposes consistently. Evidence in documentation should be provided regarding the fitness for purpose, access control, data integrity, authorisation, critical handling, audit trails, back up and retrieval, system maintenance and training. This compliance has to be integrated in the system life cycle of any computerised system.

This was posted in Bdaily's Members' News section by ComplianceOnline .