Libraport Campinas, strategically located in one of the largest industrial hubs in the country and close to the main cargo airports, has a complete structure for handling and storing foreign trade cargo in the pharmaceutical, chemical, electronic, food, and consumer goods segments.

Challenge

To demonstrate the safety and quality of the logistical service provided, particularly to pharmaceutical clients, the company sought to implement software validation according to the guidelines defined by ANVISA and FDA, the main regulatory bodies for sanitary surveillance in Brazil and the United States, respectively.

Libraport Campinas already used solutions from Full Gauge Controls – a 35-year-old Brazilian manufacturer of digital controllers – to monitor and manage the air conditioning in its warehouses and cold rooms, using its controllers connected to the Sitrad Pro internet management software, developed by Full Gauge Controls itself, which has been established on the national and international markets for over 20 years.

Solution

Understanding the fundamental importance of maintaining records of the evidence required by the pharmaceutical industry, the company opted for the consulting service of HarboR Informática Industrial to guide them throughout the entire validation process of the Sitrad Pro software. In addition to parameterization, HarboR’s consulting supported the development of all documentation and the execution of test protocols for the initial software validation and the continuous process of maintaining its validated state. The Computerized Systems Validation Guide provided by ANVISA was the basis for all the work developed. During the process, it became clear that, with proper parameterization, Sitrad Pro provides full support for ANVISA’s requirements regarding good practices for the use of computerized systems provided in RDC 301 and the requirements of CFR 21 Part 11 – Electronic Records, Electronic Signatures (US FDA agency standard for drug and food control, which regulates data security and authorizations/authentications), and thus could be used safely to manage the monitoring of critical product quality parameters.

“Libraport needed to adapt its temperature monitoring system to meet the new ANVISA standards and provide due safety and reliability to our clients. Since we already worked with Full Gauge, the partnership with HarboR met this demand, making it approved according to the strict established standards. The entire process was very well directed by HarboR, with the fundamental support of Full Gauge for the necessary adjustments.”

Luís Ardigueri, Maintenance Supervisor at Libraport

Results

With the execution of Sitrad Pro validation, Libraport was able to incorporate a series of good practices into its monitoring routines, ensuring the quality of its services. Because it consisted of a deep investigation process of the software’s functionalities and action flows, the validation provided a better understanding of the scope of benefits that Sitrad Pro could provide. For example, by scheduling automatic report deliveries to those involved, the company optimized its routines. Validation also generated evidence and provided software parameterization to prove compliance with ANVISA and FDA requirements, further enhancing security for its regulated clients.

• Documentation evidencing safety and reliability in critical quality data managed by Sitrad Pro.
• Incorporation into quality policies of ANVISA’s good manufacturing practices (RDC 301) regarding computerized systems.
• Compliance with CFR 21 Part 11 requirements.
• Reliable and secure data from Sitrad Pro for agile and assertive decision-making.