We always recommend to all companies that “Validate their computer ized systems”, but the question is, why?
The validation of a computerized system is the evaluation of the software(s) that permeate and manage processes, where it is performed and documented the various types of tests and situations about the system(s), aiming to find any Gaps that may indicate flaws in your data integrity, System security or even losses that may be significant to your company’s business strategy.
Considering the laws applied in the area of Life Science and requirements of regulatory bodies such as ANVISA, it is required the validation of systems and spreadsheets with impact on the product, and in the near future may become a requirement in other areas, in order to ensure that the final product or service arrives with the highest possible quality and that the processes are managed correctly by the software used.
When it comes to software for use for management as an ERP for example, it is essential to know if the program guarantees you the integrity of the data generated, if there are all the correct functionalities for the purpose of use, and in addition to the effectiveness of reliability on the results that the system generates, avoiding rework and waste, bringing the security you need on a day-to-day.
Another important point to highlight is the new LGPD (General Data Protection Law) law that is already in force, and should be considered by companies that collect customer or user data through software or platforms. In this case, all companies that do not fit the legal lases and user rights with the types of data treated (i.e. how the company stores or manipulates this data with their software), run the risk of getting a fine (yes, you can already take fines!), in addition to the bad reputation and legal processes.
The reasons are diverse, but one thing is certain, performing validation of computerized systems is no longer an option but an obligation of those who want to prevent major problems in the future and ensure the quality of their processes.
Here at Kivalita Consulting we are accredited partners of software such as DOCNIX and SAP B1 of B2Finance, and reference in systems validation considering the requirements of Anvisa (Guide 33), FDA (CFR21 Part 11) and other international references (ALCOA, MHRA, etc. ). ]