( b ) the manufacturer is able to demonstrate that it is capable of developing and putting in place such process control and audit trail procedures as described in subparagraph ( a ) that will comply with the security rules ;
b ) tootja tõendab oma võimet kujundada ja kehtestada punktis a osutatud protsessijuhtimise ja kontrolljälje menetlused , mis vastavad turvaeeskirjadele ;