Within the scope of software validation, studies such as creating software lifecycle, creating risk analysis where basic hazards are determined, fault conditions, design conditions, creating verification scenarios, traceability analysis are carried out.
Software validation will provide reliability for your customers, high quality for R&D studies or new products, convenience for inspection organizations and regulatory requirements.
TS EN ISO 13485 Article 4.1.6 Explains the necessity of medical devices in a clear language for medical device manufacturers.
"The organization procedures regarding the validity of the computers used in the application shall have documented quality management system software. Such software applications may, if appropriate be validated before the first use and after the changes to be made to the software or software application.
Software approaches and specific activities related to making validation and revalidation, about the use of the software must be commensurate with the risk. The continuity of the records of such activities should be ensured.
Yazılım seçimi yapılırken, yazılımı yazan firmanın kalite gerekliliğini karşılayıp karşılamadığı tedarikçi denetimi ile kontrol edilmelidir. Yazılımın işlevselliği kadar güvenilir olması ve dokümante edilebilir olması şarttır. Dizayn kalifikasyonu (DQ) (yazılım ve donanım), Kurulum kalifikasyonu (IQ), Operasyonel Kalifikasyon (OQ) ve Performans Kalifikasyonu (PQ) çalışmaları yapılabilmedir. Validasyon esnasında personelimiz sizden bilgi ve doküman isteyecektir.
While selecting the software, it should be checked with the supplier audit whether the company writing the software meets the quality requirement. The software must be as reliable and documentable as its functionality. Design qualification (DQ) (software and hardware), Installation qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) studies can be done. Our staff will request information and documents during validation.
In the process from software design to retirement, what we call software lifecycle, companies must have some procedures. There should be many written quality documents such as implementation procedures, Backup, Authorization, Data Integrity. All kinds of support in this regard are provided by us.