The LSIT Institute's mission is to safeguard public health by increasing trust in Life Sciences & Healthcare I.T. through the development of open, publicly available, best practice I.T. guidelines that help organizations better manage risk and ensure adherence to optimal compliance standards. Its charter is to facilitate collaborations to develop open, publicly available Good Informatics Practices (GIP) for the life sciences and healthcare communities.
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Mira Milovancev, Working Group Leader for the GIP Guidance Document on the Validation and Verification Chapter is top notch. Mira has her own consulting service, Mira CLE where she brings 20+ years of knowledge and first hand experience in medical systems and devices. Her heart is in engineering, I think she keeps a tool kit in her purse. Yet her depth and breadth of experience in validation, verification and compliance are great. She has managed the best and worst (including audits and warning letters, pending consent decrees that usually brings a few heart palpitations) situations to success.
We are honored and grateful to have Mira lead a team of over 15 volunteers for developing and writing content in the Validation Chapter. No dust has gathered on her feet as she developed the outline, had FDA review it, and deployed the team into action within 3 weeks. She has surmounted any and all diverse and complex areas of validation through her attention to detail and pulling together the brilliance and expert knowledge of this working group. It is heartening to see the progress and energy this Working Group has. Thank you Mira.
