24 de October de 2024

Data Governance for AI

Life Sciences companies, particularly biopharmaceutical and medical product companies, are highly regulated and need to prove that their product and its manufacturing and development processes are robust.Patient safety is impacted by the integrity of critical records, data, and decisions, as well as aspects related to the physical attributes of the products.
4 de October de 2024

How to Validate AI in GxP Applications for Life Science Companies

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

Streamlining LIMS Validation with Agile Methodologies for GxP Compliance

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

What is UDI (Unique Device identification)? Principles for system design and operation – medical devices

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.
8 de April de 2024

IT Infrastructure Qualification for Small & Medium Medical Devices Companies (and SaMD): ISO 13485:2016 Compliance

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 Validation. Award-Worthy Quality.

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

FIVE Validation Wins SINDUSFARMA Quality Award 2019.

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 Validation is a Finalist in the CPHI Pharma 2022 Event in Frankfurt.

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

FIVE Validation Receives SINDUSFARMA 2023 Award.

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.
7 de July de 2023

Success case – Catarinense

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.