21.—(1) A licensee must, in relation to the provision of the blood banking service, maintain complete and accurate records of the following:
(a)
in respect of each personnel involved in providing the blood banking service or any activity that is part of or incidental to the blood banking service —
(i)
the personnel’s role and duties; and
(ii)
the personnel’s qualifications and competencies;
(b)
the validation of any equipment or supplies used.
(2) The licensee must ensure that all records maintained under paragraph (1) are kept secure and are readily accessible when required.
[S 388/2023 wef 26/06/2023]
(3) The licensee must ensure proper document control of all documents relating to the blood banking service.