Dah dapat la sikit idea on how to do this assignment... since i was working in a plastic injection molding company... and we are now targeting to run a consumable product dimana it is mostly come from the medical business....
"Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997. Validation requirements apply to software used as components in medical devices, to software that is itself a medical devices, and to software used in production of the device or in implementation of the device manufacturer’s quality system"
No wonder la beria-ia nk study benda ni.... nk tak nk.. kena la buat.. kang assesment naik gaji tak ada markah pulak... :(......
1st..... choose equipment.. satu cukup la.....
2nd.... kena guna benda yg accurate... and need to prove that.. that thing is accurate.... apa ekk.. ?
3rd.... how to prove benda yg accurate tu... guna equipment yg dipilih... to validate the software yg digunakan oleh equipment tu... kalau setakat validation approval dari supplier... memang dah ada....
4th.... method apa yg akan digunakan untuk prove that the software used is validated....
5th... function apa dalam software tu yg nk divalidatekan... takkan semua function... setahun tak siap...
Lagi... lagi...... ????
6th... haaa... validation range..... fit for use la.. kan...
Ni baru nk kasik draft pada si director tu... eii... walaupun rupamu tidak kukenang....
chayok... chayok.... berusahalah.....
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