SMART quality & compliance
Good Documentation Practices in Regulated Environments
“Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you did a poor job no matter what you really did.” —Marco Polisena Introduction Good Documentation Practices (GDP) has evolved to be one of the essential Good Practices in regulated environments such as pharmaceuticals manufacturing for many years now. Having developed from predicate rules for record-keeping in quality system management, as well as 21CFR 11 for electronic records and electronic signatures, GDP has evolved to become a quintessential tool for documents industry. “In any regulated industry, documentation can provide…
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SMART quality & compliance
Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G. Hunter Introduction The World Health Organisation (WHO) specifies that “the purpose of validation is to confirm that the computerized system specifications conform to the user’s needs and intended use by examination and provision of documented and objective evidence that the particular requirements can be fulfilled consistently.” Validation should establish confidence in the accuracy, reliability and consistency in the performance of the system and it should also ensure that all necessary technical and procedural controls are implemented confirming compliance with good documentation practices for…
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SMART quality & compliance
Manual vs. Automated Testing
“I don’t care if it works on your machine! We are not shipping your machine!” — Vidiu Platon. Introduction: Whether we are considering testing related to Software / IT environment, we can distinguish two kinds of testing which are not always exclusive, but they can, under certain circumstances, be used in parallel on the same system, for different purposes. We are talking about Manual Testing and Automated Testing. Testing purpose can spread from the “simple” bugs finding to the assessment of user-friendliness, and it depends pretty much on the approach the stakeholders want to follow. A tester can be involved from the…
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