FDA 21 CFR Part 11

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The Challenge

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.

FDA 21 CFR Part 11 Solution

SoftExpert offers the most advanced and comprehensive software solution for compliance management, that meets the demanding needs of various global regulations. SoftExpert Excellence Suite helps companies to comply with FDA 21 CFR Part 11, while lowering the costs, maximizing success, increasing productivity and reducing risks.

The SoftExpert solution enables organizations to easily meet FDA 21 CFR Part 11 requirements, providing resources to manage records, documents, reviews, access controls, and also trainings, non-conformances, KPIs, processes and others, boosting organizational efficiency, reducing rework and waste. With online collaboration capabilities, the organization and managers can communicate and be updated about the compliance initiatives, involving more users, teams, offices and business units with a systematic and unified approach that keeps the company ready for the FDA audits.

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.

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