Experts en « Contamination Control Strategy », intervenant à toutes les étapes de maîtrise de la contamination, les équipes SAFYR® constatent année après année le volume de DATA générées par les qualifications (initiales ou périodiques), les surveillances, les analyses microbiologiques, les systèmes documentaires, la formation des collaborateurs, etc.
All data are almost exclusively stored on paper and / or isolated from each other.
However, any anticipation of drifts, search for causes, analysis of deviations (OOS, OOT, OOE, etc.) requires the cross-checking of one or more of these types of data and a transversal reading of the information and results.
While the existing tools on the market are still very segmented by EMS / LIMS activity / or non-existent (such as results from qualifications); the SAFYR® team (a pioneer in terms of digitalizing PDF reports from qualifications, for 10 years already), dreams of an All-In-One solution, dedicated to critical environments and subject to specific contamination control requirements; a solution allowing all data to be centralized on a single tool. The idea was born, the team acquired development experts and LYRA® was launched in early 2021.
In addition, LYRA® is perfectly suited to the new requirements of the next Annex 01 of the GMP.
Indeed, the CCS (Contamination Control Strategy) is now present at the heart of regulatory guidelines for bio-production environments.