AMC15 Article 15(1)(e)
Conditions for obtaining a certificate
ED Decision 2022/022/R
MANAGEMENT SYSTEM — RECORD-KEEPING — GENERAL
The applicant should ensure that:
(a) all records are accessible whenever needed; the records should be organised in a way that ensures traceability and retrieval throughout their retention period;
(b) records are kept in paper or in electronic format, or a combination of the two, and should remain legible throughout the required retention period;
(c) paper record-keeping systems use robust material which can withstand normal handling and filing;
(d) computer record-keeping systems have at least one backup system which should be updated within 24 hours of any new entry made; computer record-keeping systems should include safeguards against the probability of unauthorised personnel altering the data;
(e) all computer hardware used to ensure data backup is stored in a different location from that containing the working data and in an environment that ensures it remains in a good condition; and
(f) the records are kept for a minimum period of 5 years unless otherwise specified by the competent authority.
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