Process software validation

Regulatory management software is software that manages quality registration/records (spreadsheets, management software, etc.), as well as software used in production processes. These software must be validated, particularly when used to guarantee the safety of a device or to generate information for regulatory bodies.
Software validation helps to reduce risks and legal liability, by providing evidence that the IT system is fit for purpose.
In ISO 13485: 2016, software validation requirements have become more explicit. The 21 CFR 820 (QSR) has always required the same requirements for Medical Devices and IVD companies wishing to sell their products in the USA.
Maytal, thanks to the more than ten-year experience in software validation, can support companies to:
  • Develop procedures and protocols for validating and revalidating regulatory software
  • Develop a practical and efficient approach, proportionate to the risk taken
  • Use the validation and revalidation procedures for software applications, along with filling out the related validation reports, training and supporting the internal staff that manages the software subject to validation
  • Train internal resources and suppliers to ensure that revalidation is performed correctly each time the software is changed