Project Description

  • validation of computadorized systems

Computer Systems Validation

The Computer Systems Validation is a documental process that has as purpose to protect the integrity of the related data to the automated industrial production, guaranteeing a complete traceability of information assuring the compliance of the standards and requirements of the main regulatory agencies in the world (Guidelines to GMP Volume 4 – European Commission; EMA Annex 11; FDA 21 CFR Part 11, etc), besides the implementation of the Good Practices rules and optimization of the production, the validation reflects also in the reduction of costs, lifting of the product quality, and helps to assure the health of the final user.

In Brazil, the Computer Systems Validation is an ANVISA (National Agency of Public Health Vigilance) requirement, as well in several others important regulators bodies around the world.

MAIN ADVANTAGES OF THE VALIDATION

  • Guarantees the integrity of the productive process’ information;
  • Contributes to improvement of the final product’s quality;
  • Allows the utilization of all automated resources available in the system;
  • Allows that the whole technical team be holder of deep knowledge about the systems studied;
  • Avoids the loose of knowledge if eventually a professional leaves the company, reducing the business risks;
  • Optimizes the utilization of computer systems, allowing great automation of the processes and increasing reliability;
  • Directs the team to necessary actions based on risks, reducing the production downtime and consequently, reducing loses;
  • Increases the reliability of the recorded data in processes, avoiding operational mistakes.

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