Importance of Computerised system for wholesalers

by | Jan 8, 2020 | Blog

A Risk-Based Approach to compliant GxP Computerised Systems are guidelines, not regulations. It is, therefore, not mandatory to follow any methodology. However, you should approach the computer system validation that is generally accepted within the pharmaceutical industry.

Should you operate your computer system in a manner that did not prevent the data stored by the system from being permanently lost or corrupted in the event of physical damage to the server. You must risk asses how to recover any data lost or damage from the system or to prevent or reduce the risk of future physical damage to the server. A state of data can be lost following a system crash and failed to attempt to recover lost data, seriously violating the regulation. Your computerised system should record stock movements of the drugs, also maintain the forms and records associated with procedures including Warehouse procedures and administrative records. Should follow Good Documentation Practice as well on paper-based documents.

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Having just completed the very informative API and Clinical Trail course (thank you Shankar) I was reminded of the traps we can fall into whereby we try to keep ourselves in our little boxes. At the MHRA symposium, I have heard several times comments such as:- “no, I’m not doing the GMP day as it’s not relevant to me” or “GDP? Oh, that doesn’t apply to us as we are manufacturers”. I am sure these comments were made well out of the earshot of MHRA personnel and on the face of it see… Read more
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