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21 CFR Part 11 Compliance requirements are a means, not an end. The FDA regulations define what controls covered organizations need to ensure their electronic records are accurate and correctly authenticated. Those accurate records, in turn are what ensure your products are safe and your findings sound.

It’s natural for organizations to feel frustration with the cost and complexity of new controls. However, it’s important to realize that 21 CFR compliance rules are more of an asset than a liability. Your reputation and the lives of your consumers rely on keeping precise records, free of both intentional tampering and inadvertent errors. Partnering with a 21 CFR 11 compliant SAP HANA® cloud provider can minimize the cost and disruption of implementing required controls, and prevent the mistakes that can jeopardize compliance.

21 CFR Compliance Guide — Why Outsource ERP

Title 21 of the Code of Federal Regulations (CFR) applies to systems that use electronic records. Good manufacturing, laboratory and clinical practices use signatures and manual review to verify authority, verify accuracy and ensure accountability. The regulations allow organizations to use electronic signatures and controls as a replacement for manual processes.

21 CFR Part 11 also addresses the security challenges posed by using electronic records. Unlike paper records, electronic records can be remotely accessed and edited. As such, 21 CFR 11 mandates an array of controls to prevent unauthorized tampering or access, while allowing businesses to reap the benefits of electronic recordkeeping. Everything from login and authentication to the hardware documentation protecting your 21 CFR 11 data center needs to be carefully designed and run to mitigate risk and ensure compliance. The benefits of choosing an ERP outsourcing partner with extensive security and compliance experience is obvious.

21 CFR Compliance Guide — Quality Management

Quality Management (QM) is the center of a successful 21 CFR 11 program. 21 CFR compliance requirements leave a lot of leeway as to the technical details of implementation, allowing organizations to create controls that meet their needs.

For example, all organizations need authentication, but for some a password and ID number may be adequate, while other organizations will need to implement voice recognition or fingerprint scans. You’ll also need procedures to ensure workers are changing their passwords regularly, and to rescind or alter access credentials when employees leave or change job duties — procedures that need to be configured to the unique needs of your business.

GRC software is ideal for these purposes. It audits and reports on access control and facilitates quick remediation of internal security and compliance issues, reducing risk. Operated by a partner with an excellent quality control and improvement program, it enables your organization to maintain and update procedures in line with changes in business processes and regulatory pressures.

Managed ERP in The 21 CFR compliant Cloud Solution

Symmetry offers 21 CFR Part 11 compliance for SAP HANA. Our services meld high-touch SAP HANA cloud and hosting services with enterprise-class security and compliance. Using sophisticated tools like ControlPanelGRC® combined with 24 hour monitoring, threat analysis and incident response, we ensure continuous compliance, security and system performance and availability for our partners.

Contact us to learn how Symmetry can take the worry out of 21 CFR Part 11 Compliance.

Cindy Rasey, Compliance Manager

Cindy Rasey, Compliance Manager

Since her start with Symmetry in 2003, Cindy Rasey has been deeply rooted in the SAP ecosystem at every level to gain a holistic understanding of the business. With a BBA in MIS from UW-Milwaukee, she leads audits to validate continued compliance of existing certifications, implements new compliance regimes, and develops and enforces company-wide SOPs and policies to ensure all Symmetry’s services are delivered consistently and securely. She and her team successfully implemented Symmetry’s formalized Quality Program to control documents, approvals and track training - all while meeting 21 CFR Part 11 and other compliance regulations. By leading implementations and upgrades of business critical systems, she ensures the most effective and efficient tools are utilized.