We provide end-to-end consultancy to your team to identify the potential breach of soft and physical data integrity from 21CFR Part 11 and EU guidance’s, hand hold them to design the CAPA to bridge the gap, deploy good documentation practices, strategize methodology to reduce human error by practicing behavioural GMP and monitor the progress of your Organization to meet with the pre-set quality matrices.
. Assessment of Completeness, accuracy and consistency of data – attributable, legible, contemporaneous, original and accurate (ALCOA) in the GCP, GLP and GMP domains;
. Computer system validation – discrete, integrated, server based, tools, virtual and physical;
. Audit trial and 21 CFR Part 11 compliance. Verification of data integrity;
. Setting an integrated data integrity policy and monitoring system to verify compliance;
. Good documentation practices as per ISO and other quality systems;
. Scientific approach to handle Human/Work force errors;
. Identifying the non-compliant practices – risky, reckless and unintentional behaviours;
. Poka-Yoke approach of ‘mistake-proofing’ for Human factor engineering;
. Error management, Improvisation plan and monitoring system;
. Teller made behaviour based GMP model, boosting quality culture in life science and precise electronic industries (fiber optics, aviation, defence, etc).
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