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.
From day one,
agile compliance
that empowers
your team!
4 de October de 2024
The integration of Artificial Intelligence (AI) into the Life Sciences industry brings innovative potential, from drug discovery to personalized medicine. However, incorporating AI into GxP (Good Practice) environments, which are governed by regulations to ensure product safety and efficacy, introduces additional challenges in AI validation.
26 de September de 2024
Laboratory Information Management Systems (LIMS) are specialized Quality Control systems designed to collect, manage, and streamline the flow of analytical data in laboratories. They handle tasks such as the approval of analyses, ensuring the traceability of samples and reagents, and maintaining records for equipment maintenance and other critical laboratory operations.
26 de June de 2024
Principles for system design and operation – medical devicesUDI is based on a sequence of numeric or alphanumeric characters created using worldwide accepted device identification and coding standards. Allows unequivocal identification of a device on the market.
21 de May de 2024
Organon is a global health company that leads in the development of medicines for women. Its purpose is to contribute to women having more health and well-being in all stages of life.
24 de April de 2024
Networking opportunities are crucial at events, aren't they? However, many online events or webinars lack the chance for interaction not just with the speaker but also with fellow attendees, right?
8 de April de 2024
ISO 13485 is a globally recognized set of standard quality management system (QMS) requirements applicable to companies engaged in the design, production, installation, servicing, and manufacturing of medical devices.
3 de April de 2024
FIVE was one of the participants in the SINDUSFARMA Quality Awards 2019 Ceremony under the categories of "Service Provider for Production" and "Service Provider for Quality".
The awards ceremony of that year was in its 23rd edition and aimed to encourage improvement in quality management, rewarding outstanding suppliers and service providers of the Pharmaceutical Industry area.
3 de April de 2024
On the 20th of May 2019, the awards ceremony of the 23rd edition of the SINDUSFARMA Quality Awards of that year took place.
The ceremony traditionally awards suppliers of the Pharmaceutical Industry in various areas, which are outstanding for their Quality System. In 2019, the event took place at Credicard Hall, in São Paulo, and was attended by many illustrious guests such as actress Elizabeth Savalla and journalist Érica Reis, who served as masters of ceremonies.
3 de April de 2024
FIVE started providing services in 2008 and the first operating procedures were established in 2012. Even without an implementation of a Quality System, FIVE was already studying and addressing the standardization and quality of its deliverables.
3 de April de 2024
The CPHI Pharma Awards Ceremony is a celebration of innovative companies within the pharmaceutical sector around the world.
This event recognizes projects that drive significant advances in this field and provides global visibility for groundbreaking ideas.
3 de April de 2024
The Sindusfarma Awards Ceremony aims to recognize outstanding companies across the country in Good Manufacturing Practices.
Since 2018, FIVE Validation has enrolled to participate in this awards ceremony, which takes place in several selection phases. The first is the voting of the companies within the pharmaceutical industry to select those who will be ranked in the second phase, and the second phase consists of auditors auditing each elected candidate’s quality system.
20 de February de 2024
This covers the overall strategy, helpful tips, and ways to leverage documentation from another unit within the company for maximum benefit.
31 de January de 2024
Welcome to our blog! In this session, we will explore the vital role of suppliers and their collaboration with regulated companies, as well as delve into the world of third-party validation processes.
10 de November de 2023
A startup's path to growth involves numerous obstacles and stages, particularly for those operating in regulated markets such as Medical Devices and Health Tech.
23 de October de 2023
Validation is a documented process to prove that equipment, systems, spreadsheets, processes, and procedures work safely and efficiently to protect patients and clients, and to ensure product quality and data integrity.
21 de August de 2023
“By adopting agile methods, the aim is to save time, enhance agility, and avoid obstacles to innovation during the validation process.”, - Silvia Martins.
7 de July de 2023
Alkaloid AD is a company with more than eight decades of experience, operating in the field of manufacturing of drugs, cosmetics, and chemical products.
7 de July de 2023
History: For over 75 years, we have been a fount of health!
Driven by the purpose of “Being a fount of health”, Catarinense Pharma operates in the pharmaceutical area in the development and sale of medicines, herbal medicines and food supplements, all designed to contribute to the well-being and quality of life of Brazilians.
21 de June de 2023
Life Sciences companies face several challenges in developing and keeping their systems updated.
31 de March de 2023
Some important points that the second edition of GAMP5® and CSA bring and make us think about ‘how system validations will be from now on.