The Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) establishes security requirements to the life sciences industries, that follows its guidelines to ensure that electronic records and electronic signatures are legitimate and authentic, allowing in many situations to replace their paper equivalents, and also to improve the security and trustworthy of IT systems.
Demand for medicine is increasing fast, at the same time that regulatory agencies makes more rigid the approval process for new medicine. The strong regulation is posing challenges, and executives needs to drive all efforts to ensure that stringent regulatory compliance and quality standards are met, to avoid product safety troubles or regulatory agencies punishments, that can weaken the company image in the market, reducing revenues and market share.
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Document control
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Controlled copy and digital signature
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Document review
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Audit trail
Main Benefits
Reduce efforts to effectively comply with FDA, ISO and other regulations.
Streamline the elaboration, review and approval of compliance documents.
Eliminate scattered, duplicates and obsolete documents.
Ensure the access to the updated documents to prevent process deviations.
Easily responds to FDA audits with available and traceable information.
Promote the company commitment to quality and customer satisfaction.
Provide a better customer experience with products and services.
Customer success stories
Featured Resources
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