Software Validation

Computer System Validation (CSV) is a required activity for FDA-regulated environments, the goal of which is to document that a system is secure, reliable, and fit for its intended purpose. The point is not to produce a mountain of documentation but rather to demonstrate that the software satisfies its intended use.

Hyla Soft helps companies in the Life Science, Medical Device, and other manufacturing sectors streamline their processes and bring new and existing products to market. Given the pressure from industry regulators such as the FDA, MCA, and the EU, our customers require a high level of commitment in order to achieve high quality standards. Hyla Soft helps companies navigate the complexity of those standards while supporting the validation effort.

With Hyla Soft's guidance and our team's advanced experience in defining proper validation test cases, Life Science and Medical Device companies can meet industry requirements as well as their own business goals. Our proven Software Validation approach and team will:

  • Establish that your system complies with the required standards, rules, and regulations and that it will continue to do so over its lifetime
  • Provide controlled documentary evidence that shows that the system complies with industry standards

Choose Hyla Soft as your validation partner and reap the benefits from the value our expertise will provide your business:

  • Deep knowledge in implementing industry standards and best practices, like GAMP® 5, supporting the customer's organization from Risk Management through V Model implementation (IQ/OQ/PQ)
  • Knowledge of automated enterprise software to target the validation process: these tools can improve efficiency, productivity and reduce the effort in case of audits
  • Complete coverage of the implementation and validation process, with a proven record in successfully implementing PLM, MES and Quality solutions for manufacturing companies

Hyla Soft is committed to constantly improving our customers' Manufacturing Operations, linking together different aspects of production with the best technology and most reliable best practices. Partnering with Hyla Soft means gaining a deep understanding of business and industry requirements, tailored solutions for your needs, and a trusted advisor for your Computer System Validation initiative.

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