19 de January de 2023
Verification is a process that determines the quality of a product. This step includes all the activities associated with high-quality production, (i.e., testing, inspection, design analysis, specification analysis, etc.).
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27 de December de 2022
Using a Waterfall model is a very common practice for project delivery of paper-based validation, or validation using a text editor.
27 de December de 2022
Industrial automation is defined as the use of equipment, hardware, and specific software to automate an industrial process: whether production optimization; control and traceability; monitoring; analysis performance and tracking; among others.
5 de December de 2022
Validation Using a Text Editor (e.g., Microsoft Word) is One of The Biggest Bottlenecks in The Regulated Industry.
5 de December de 2022
Although it seems at first that a Requirements Management System (RM) and a Validation Lifecycle Management System (VLMS) are similar, the RM has a limited scope in relation to VLMS conformity.
25 de October de 2022
Perspective from Life Science SAP® user, Implementation Vendor, Project Manager, Validation Specialist, and Integrators.
9 de September de 2022
Activities and changes in consumer behavior are proving that it’s only a matter of time before the use of paper is obsolete.
22 de August de 2022
Cloud Computing plays an essential role in the digital revolution that most companies are now experiencing.
12 de July de 2022
This article was written by Silvia Martins and disclosed by PDA (Parenteral Drug Association). Read more.
5 de April de 2022
A term often used in industries is time-to-market, which is the amount of time from the conception of a product to its release.
1 de April de 2022
Many companies have been struggling to plan their migration journey from SAP ECC to S/4 HANA® in the last few years.
25 de March de 2022
Silvia Martins CEO and co-founder of FIVE Validation and Jon Nugent from CoursWorx have envisioned this session to help businesses better understand the importance of paperless validation.
14 de March de 2022
SAP HANA® ERP (Enterprise Resource Planning) implementation process has already started in the pharmaceutical market.
10 de March de 2022
This webinar event was broadcast on Oct 28th 2020
7 de December de 2021
Return on investment, or ROI, is a financial metric used to measure the returns obtained from a given amount of invested resources.
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.
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.