Telstar’s qualification reports & GMP quality validation services in real time have been extended to pharmaceutical processing equipment and covering in addition equipment installed in laboratories and hospitals. The implementation of an innovative proprietary digital application facilitates the process of performing data collection and technical measurements of clean rooms and controlled environment equipment in real time without interrupting the manufacturing process and speeds up the issuance of the final report with the highest level of reliability.
The new digital data measurement and control application has been widely used and tested by Telstar over the past four years in the clinical and biomedical environment. In 2016 the company, with 30 years of experience in GMP validation, started using a pioneering system for automated management of real-time reports for equipment installed in laboratories and hospitals, which has enabled the generation of nearly 3,000 reports to be accelerated.
In addition to speeding up the process of obtaining environmental measurement reports, the implementation of the digital application ensures the integrity of the recorded data. The data collection phase is carried out without interrupting at any time the ongoing manufacturing process of the pharmaceutical industry, instantly freeing up the analysed equipment and rooms to continue with the production process. At this stage, the industry obtains a pre-report immediately on-site and in real time, while Telstar’s specialized team carries out a thorough process of in-depth analysis and review, both a technical and quality review, to ensure zero error in the results recorded in the final validation report. The client receives the final report in digital format, which can also be accessed via extranet through a proprietary application that allows companies to view their documents and notifications in an agile, reliable, fast and secure way.
The report developed by the specialized Telstar team offers high technical quality. A meticulous analysis and review process translate into an optimum degree of reliability as the variations reflected in the report are fully reproducible in the subsequent audit processes.
Telstar’s application of GMP quality qualification and validation, approved according to current GAMP standards, is part of its comprehensive customer service for the optimization, updating, improvement and modernization of operational processes and production and research equipment, and support for the entire life cycle of high-tech equipment.