To deal with these challenges and to comply with rigorous FDA regulatory requirements, SoftExpert Excellence Suite is an integrated web- based management system, designed to help medical device companies to fully meet 21 CFR P ART 820 regulations.With So ftExpert Excellence S uite such organizations c an e asily a nd effortlessly:• Achieve 21 CFR P ART 82 0 compliancy quicker.• Employ industry- proven solution t hat is se amlessly integrated.• Reduce t he cost involved t o co mply with FDA regulati ons.• Increase end us er acc eptance an d pr oductivity.• Monitor and re port pr oduct de fects.• Automate t he r equired regulat ory data c ollection of device- history records.• Manage product complaints an d a dverse events .• Manage closed- loop CAPA processes.• Communicate quality iss ues.• Modify p rocedures to s uit u nique b usiness requirem ents.• Access procedures while m aintaining co mplete document sec urity.• Maintain co mplete audit trail rec ords.• Eliminate rework.• Manage product specifications.• Maintain acc essible a nd sec ure pr oduct in formation.• Minimize c osts by saving o n c onsulting s ervices.• Ensure t he authenticity, integrity, an d c onfidentiality of electronic rec ords.• And m uch mo re …SoftExpert Excellence Suite provides organizational efficiency, process control, and flexibility to help simplify the tasks involved in managing data and information. It will also help your organization make better decisions in ...