4 de October de 2021
Probably we still validate using paper because we are used to it because it is the only way we know how to do it or because most companies still do so.
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24 de September de 2021
In general, the serialization and traceability projects consist of obtaining information from each commercial drug unit in its entire chain.
16 de August de 2021
Paperless validation is an electronic process of ensuring that equipment, software, spreadsheet, utilities, cleaning, and processes.
13 de October de 2020
Qualification and Validation: Regulatory agencies such as FDA, EMA and WHO, require that the pharmaceutical, medical device and supply chain industries prepare documents that prove the proper functioning of processes, systems, and equipment. Read more.
22 de January de 2020
One of the most used systems in industries is ERP (Enterprise Resource Planning), which is the platform through which, among other functionalities.
22 de January de 2020
The validation proves with documentation that computer systems used in industrial production adequately fulfill their automatic functions and contribute to ensure the traceability of produced batches and meets GMP regulations.
22 de January de 2020
Laboratory Information Management Systems are quality control laboratory systems responsible for collecting and managing the flow of analytical data, approval of analyzes, traceability of samples and reagents, maintenance records.
22 de January de 2020
Motivated by an increase in the number of nonconformities in the Pharmaceutical Industry, regulatory agencies have issued guidance in recent years on how to keep intact critical data.
22 de January de 2020
The concept of critical data integrity generated in production requires that a complete, consistent, accurate data throughout its life cycle is maintained.
22 de January de 2020
Blockchain was created in 1991 but it became known only in 2009 with Bitcoin. It aimed to be a viable alternative to financial relations that could be made directly between people.