Experts in "Contamination Control Strategy", intervening at all stages of contamination control, the SAFYR® teams observe year after year the volume of DATA generated by qualifications (initial or periodic), monitoring, microbiological analyzes, systems documentaries, employee training, 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.