![]() ![]() There are those who think that in order to be in compliance with ISO 900x, it MUST be complicated. For example, the FDA does not accept electronic signatures at this time, but are considering them for possible consideration.Īs far as software goes, be careful. IMHO, the approval method SHALL be dependent upon what is appropriate. That is all.Īs far as electronic signatures go, there are those that accept them, others that do not. The FDA’s QSR does require signatures in some clauses, maybe QS 9000 does, but ISO 900x does not. The objective evidence shall contain and explain the “complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.” This is another myth.įor example, “Purchase orders shall be reviewed and approved.” Neither ISO 900x nor ISO 8402 state that approval means signature. As a matter of fact, I just did a search of ISO 9001 and the word ‘signature’ does not appear ONCE. No where, and I mean no where, does ISO 900x require signatures, just approvals. Click to expand.I am sorry guys, I know this is probably going to stir debate.
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