Simplify Your 21 CFR Part 11 Compliance With ERP Solutions

1. Simplify Your 21 CFR Part 11 Compliance With ERP Solutions Ensuring the safety and quality of products in organizations that are regulated by the Food and Drug Administration (FDA) matters due to the direct impact on users' health and lives. The 21 CFR Part 11 is the gold standard for manufacturing practices in the United States. So, to obtain and maintain FDA approval for their products, companies must comply with these regulations. As companies shift to digital systems, replacing traditional paper-based record-keeping, the FDA introduced important regulations. These regulations concern the criteria for electronic records and signatures that are considered equivalent to handwritten signatures and manual records. Adherence to these guidelines ensures the authenticity, integrity, and reliability of electronic records used or submitted to the FDA. If you are still struggling with 21 CFR Part 11 compliance, Cyret can help! With efficient auditing tools for 21 CFR Part 11 compliance, companies can now

2. reduce regulatory burdens, leverage automation, boost productivity, and build a secure environment focused on achieving high-value work. Read on to learn how implementing the right ERP software can help you comply with 21 CFR Part 11 and achieve operational excellence. Key Requirements of 21 CFR Part 11 The key requirements of the regulation include: ● Record Retention: All electronic records must be kept for at least two years. It ensures their security and accessibility. ● Security and Access Controls: Organizations must establish policies that address access and use of electronic records. ● Audit Trails: Organizations must have a reliable audit trail that records all activities related to electronic records and system actions. ● System Validation: Organizations must have a system validation process ensuring all systems remain unchanged throughout production. ● Data Integrity: Organizations must ensure that all data is accurate and complete. ● Electronic Signatures: Organizations must ensure that all electronic records are signed with a traceable and secure electronic signature. Significance of Part 11 When companies comply with 21 CFR Part 11, they get the following benefits: ● Regulatory Compliance: Compliance ensures adherence to industry guidelines. Organizations can avoid penalties, warning letters, or bans arising from non-compliance.

3. ● Data Integrity: Accurate and unaltered data is essential for product quality, patient safety, and decision-making. Part 11 compliance assures that data integrity is optimally maintained. ● Efficiency: Moving to electronic systems reduces the effort, time, and cost associated with paper records. It also enables fast audits and regulatory submissions. ● Risk Mitigation: By implementing secure audit trails, companies can identify issues quickly, reducing the risk of data breaches or fraud. Challenges in the Absence of ERP Solution for Enabling 21 CFR Part 11 Compliance With a manual, complex process, achieving 21 CFR Part 11 compliance can be challenging for companies due to the following reasons: ● Error-Prone Manual Processes: Manual record management increases the chances of human error. Whether in data entry, filing, or record-keeping---errors can cause compliance violations. ● Difficulty Maintaining Audit Trails: Manually tracking changes in data takes a lot of time. Creating reliable audit trails without an ERP solution is a lengthy process that can lead to inefficiencies during audits. ● Inefficient Access Control: Paper-based or outdated digital systems cannot secure data from unauthorized access. It puts sensitive data at risk and compromises data integrity.

4. ● Complex Systems Validation Processes: Validating non-dedicated systems is hard to manage and may not meet the validation requirements of Part 11. ● Resource and Time-Intensive: Preparing for audits and ensuring compliance without centralized systems demands extensive resources and effort. How does ERP Software Simplify 21 CFR Part 11 Compliance? Here's how ERP solutions from Cyret can make compliance simpler: Automated Audit Trails ERP software is designed to record every system event, including -automatically ● user actions ● data modifications ● system errors These audit trails are time-stamped and immutable, ensuring transparency during inspections or audits. System Validation Made Easy The software is pre-validated for compliance with regulatory standards. It significantly reduces the time and effort needed for system validation, enabling companies to deploy the software quickly. Secure Access Control Role-based access controls ensure that only authorized personnel access specific records or take specific actions. Multi-factor authentication adds an extra layer of security, safeguarding data.

5. Integrated Document Management Cloud-based software centralizes all records and documents, enabling seamless management of standard operating procedures, quality records, and training materials. It efficiently eliminates the risk of incomplete or misplaced documentation. Electronic Signatures The platform ensures that electronic signatures meet necessary compliance requirements. Every signature is unique, time-stamped, and linked to the record, providing reliability. Streamlined Reporting and Analytics ERP tools for 21 CFR Part 11 compliance provide real-time dashboards and analytics, helping companies monitor compliance metrics effectively and make informed decisions. The bottom line If you want to streamline compliance with 21 CFR Part 11, leveraging advanced ERP tools can help you improve efficiency and obtain regulatory excellence. Take the next step towards meeting compliance by consulting the experts at Cyret. Our team is ready to assist you in leveraging the power of robust ERP solutions and guiding you through the implementation process. Achieve digital transformation in your sector with Cyret as your tech solution partner.