WHAT'S
Compliance
In stringent regulated environments and SOX, FDA and ISO environments, a nonconforming control, service, product, material, or component could lead to costly fault, rework and scrapping, or worse, a recall. Control, Quality, Reliability and Safety depend to a great extent on its conformance to specifications and parameters that have been tested, proven safe, and approved. The SOX implementation when evaluating and testing controls, most popular ISO standards (ISO 9001, ISO 13485, ISO 14001, SA 8000) and FDA's Current Good Manufacturing Practice (CGMP) regulations 21 CFR Part 211, 21 CFR Part 820 all require proper disposition of non-conformances.
FACTS
It´s important to promote a corporate culture of integrity to get the goal of their compliance programs.
Attention is needed: leaders expect management will require more/much more attention.
Conduct-related infractions spent globaly a large of amout that could be used in improvements.
The time spent - at least na entire day per week - in tracking and analyzing regulatory change.
APP FEATURES
iB Compliance is a configurable and easy-to-use process enabled application designed to automate, manage, and streamline paper-based processes for identifying, evaluating, reviewing, and handling of non-conformances of all type: controls, services, processes, materials, components, parts, and finished products. It is completely integrated with other iB Applications, allowing the implementation of Corrections and Corrective, Preventive and Improvement Actions. In process management, internal control management, regulated environments, FDA and ISO environments, non-conformance management is a key to attaining quality and compliance.
01
Applicability Analysis
iB Compliance helps organizations to be in advance of the ever alteration world of regulative compliance. Conduct global to local applicability analysis, identifying the relevant regulatory requirements for all levels of your business.
02
Compliance Documents
The documents managed by iB Documents fulfill the role of being in compliance with the rules and standards of the organization. The application provides the necessary support to maintain the proper certifications guaranteeing what is established by them.
APP FEATURES
iB Compliance is a configurable and easy-to-use process enabled application designed to automate, manage, and streamline paper-based processes for identifying, evaluating, reviewing, and handling of non-conformances of all type: controls, services, processes, materials, components, parts, and finished products. It is completely integrated with other iB Applications, allowing the implementation of Corrections and Corrective, Preventive and Improvement Actions. In process management, internal control management, regulated environments, FDA and ISO environments, non-conformance management is a key to attaining quality and compliance.
RESOURCES
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Para ajustar os recuos para a lista inteira, selecione um dos marcadores ou números. Para ajustar o recuo de um único item de lista, selecione o texto no item da lista que você deseja ajustar. Em seguida, clique com botão direito e selecione Ajustar recuos da lista para abrir a caixa de diálogo Ajustar recuos da lista. Em seguida, clique com botão direito e selecione Ajustar recuos da. Ajustar recuos da lista para abrir a caixa de diálogo Ajustar recuos da lista.
TESTEMONIALS
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Barack Obama / USA Cheif Officer
LICENSING
The licensing is modular and tailored to the customer needs. The amount of licenses can be acquired in a scalar manner to small as well as to large companies. The installation procedure can be in cloud or on-premise, leaving the client and infrastructure team with the best operating format. The instalation is fast, easy and userfriendly leaving the applications ready to be used in a short time. In the installation can be contemplated the legacy import so that the applications can begin working with previous information already loads.
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