Anyone working in or seeking opportunities in regulated industries that comply with BPx will always need to stay updated. Among the training options are system validation courses aimed at equipping professionals to handle the demands of the industry, both in the national and international markets.
The field of systems validation welcomes professionals from a diverse range of backgrounds. So, if you’ve ever wondered who can work in validation, know that this is a very broad market. Pharmacists, chemists, biologists, engineers, developers, and professionals from other backgrounds who are interested in working in the pharmaceutical, medical products, cosmetics, pharmochemical, food, and other industries can find opportunities in this field. System validation training is designed precisely to cater to this diverse audience.
What is the system validation?
System validation is a process of documentation and testing that aims to verify that a system used in regulated industries fulfills the purpose for which it was designed in accordance with the sector’s good practices throughout its life cycle.
Every computerized system in regulated industries that is part of the production, quality, documentation and storage processes, among others, needs to be validated.
This regulation is necessary to guarantee the proper functioning of these systems, traceability, data security and integrity, product quality and consumer safety.
The entire process of validating computerized systems is based on the requirements of ANVISA, the CFR (Code of Federal Regulations) Title 21 – Part 11 of the FDA (Food and Drug Administration), GAMP (Good Automated Manufacturing Practices), ANVISA’s Computerized Systems Validation Guide and ANVISA’s Normative Instruction – IN No. 134, of March 30, 2022.
If you want to go deeper into the subject, we have an article explaining everything about the validation of computerized systems.
Why invest in validation training?
The world is becoming increasingly technological and interconnected, and regulated companies are continually evolving, aiming to automate their environments, investing in artificial intelligence systems, and more. Consequently, their processes become more robust, assertive, and deliver higher quality to the consumer.
To meet the demands of this evolving market, systems validation training provides essential content, enabling professionals to enter the industry in the best way possible.
A systems validation course should cover:
- Data integrity;
- the fundamentals of software validation;
- types of computerized systems;
- current regulatory requirements;
- validation methodologies;
- process steps, and more.
And what are the benefits of investing in validation training?
1) Compliance with legislation
For many industries, system validation is crucial to meet regulatory requirements. According to ANVISA regulations, companies in the pharmaceutical, pharmochemical, cosmetics, food, sanitizing, and medical gas industries must conduct system validation.
2) Professional training
System validation training is an excellent way to enter a new field and grow professionally. System validation professionals are highly valued, given the critical importance of their role in regulated industries.
3) Competitive advantage
Although it is not mandatory in Brazil for some sectors, such as the veterinary and food industries, system validation has grown and become a trend in these sectors. For both individuals and companies, mastering software validation can open up new business opportunities.
4) Insertion into the international market
In the international market, system validation is required in many other industrial sectors than what we already see in Brazil. This means that companies that want to enter these markets will need to comply with these guidelines and validate their systems, while those that already do so will find it easier to enter these markets. Additionally, many international companies are looking for professionals qualified in systems validation to work outside Brazil.
What to look for in a validation course?
How do you choose a validation course that delivers what the market is looking for in a professional? Here are some tips to serve as a guide.
1) Course updated on current regulatory requirements
Regulatory requirements are always changing. A good validation training program needs to be updated and not outdated. Therefore, it is important to conduct thorough research to check whether the course is using old resolutions and terms, and whether the program or materials are in line with the latest developments in the validation sector.
2) Course taught by professionals in the field and recognized companies
Another point to pay attention to is the company in charge of the course and the composition of the teaching staff.
Experience is one of the most valuable characteristics when it comes to validation. Therefore, you should inquire about the background of the individuals responsible for the course.
3) Course with in-depth theoretical content
The validation of computerized systems is a discipline with many concepts that need to be understood in depth, including legal, computer, quality system, and business notions. These elements must be integrated to form a well-rounded professional in regulated industries.
A good validation course will not only explain but also demonstrate, apply, correct, and test its students, thereby training highly technical professionals to thrive in the market.
4) Emphasis on the practical
Similarly, validation training should incorporate day-to-day concepts experienced within regulated industries, providing a practical vision that equips professionals with the knowledge of what to do and how to do it.
It is essential that students exit validation training with practical skills, enabling them to enter the job market and fulfill their duties. This includes the ability to draft validation documents, conduct tests, participate in related audits, and contribute to the quality, integrity, traceability, and security of data within a regulated environment.
Validating systems is with Organex
Organex is a company with almost two decades of experience in regulated industries, specializing in the validation of computerized systems, as well as working in other sectors and industries.
We offer solutions in:
- Structuring the systems validation area;
- Mapping and elaboration of user requirements;
- Validation of information systems;
- Validation of automation systems;
- Validation of electronic spreadsheets;
- Qualification of systems and services suppliers;
- Qualification of the IT infrastructure;
- Gap assessment of bpx software ;
- Audit;
- Drawing up functional and technical specifications;
- Training;
- Allocation of professionals.
We believe that our success lies in guiding health and wellness companies to fulfill their roles safely and with excellence. To achieve this, one needs to be highly trained.
Validation training is an excellent way to start or take your career to the next level, but if you want to learn more about the regulated industries, visit the Organex website!
