For FDA-regulated industries such as pharmaceuticals and manufacturing, adhering to 21 CFR Part 11 compliance is critical for ensuring document accuracy, security, and traceability in electronic records and electronic signatures. Foxit eSign provides a comprehensive solution that simplifies compliance with these stringent FDA guidelines, enabling organizations to streamline their document processes while maintaining the highest levels of security and accountability.
- 1. Comprehensive Compliance: Foxit eSign ensures full compliance with FDA’s 21 CFR Part 11, alongside other regulatory frameworks like HIPAA, UETA, ESIGN, and eIDAS. This makes Foxit eSign ideal for FDA-regulated companies that require legally binding electronic signatures and recordkeeping that can withstand regulatory scrutiny.
- 2. Enhanced Data Security: Foxit eSign provides robust security features, including SOC 2 Type II compliance, 256-bit encryption, and secure U.S. and European cloud servers. Organizations can control access to documents, password-protect sensitive files, and limit when and where documents can be edited or signed, ensuring complete protection of sensitive data.
- 3. Comprehensive Audit Trails: Foxit eSign’s system audit tools provide complete visibility into document activity, tracking who accessed or signed a document and when and where each action occurred. This thorough audit trail simplifies FDA audits, making it easier to trace issues and efficiently meet documentation requests.
- 4. Streamlined Approvals and Sign-Offs: Foxit eSign simplifies vendor approvals and sales processes by enabling electronic approvals from any internet-enabled device. This capability reduces material ordering and sample collection delays, ensuring continuous business operations without the slowdowns caused by traditional paperwork.
- 5. Accuracy and Validity of Signatures: With signer delegation and sequencing options, Foxit eSign ensures the correct individuals sign documents in the proper order, reducing errors. Additionally, electronic signatures are tamper-proof, making documents more secure and more accessible to verify than wet ink signatures.
By adopting Foxit eSign, FDA-regulated organizations can improve operational efficiency, maintain strict compliance, and ensure the security and validity of their digital workflows.
Download the full whitepaper to learn how Foxit eSign can enhance compliance with FDA 21 CFR Part 11.