This article will explore the significance of data backup and restore processes under 21 CFR Part 11, specifically focusing on the Salesforce platform. Part 11 of Title 21 of the Code of Federal Regulations, Electronic Records; Electronic Signatures (21 CFR Part 11) was drafted to govern electronic records and signatures in regulated industries such as Pharmaceuticals, Life Sciences, and Healthcare. The regulation objective was to ensure that electronic records are reliable, secure, and comply with the same standards as traditional paper-based systems.

21 CFR Part 11 backup mandates that systems managing electronic records meet specific criteria to ensure record integrity, security, and accessibility. A critical aspect of this regulation involves robust backup and restore procedures, which are essential for protecting electronic records throughout their retention period. For organizations using platforms like Salesforce, implementing a compliant data backup and restore solution is necessary to meet regulatory requirements and safeguard data.  The article highlights the importance of deploying enterprise-grade release management, data backup, and security solutions to comply with these regulations.

Understanding 21 CFR Part 11 Backup & Restore

21 CFR Part 11 backup requires organizations to regularly back up their electronic records to ensure their integrity and accessibility throughout the required retention period. Even in the event of system failure, the organization must be able to retrieve complete and accurate data. These backups should be stored securely and managed with proper access controls to maintain data integrity, essentially treating electronic records the same as paper records, requiring them to be readily available for inspection by the FDA.

The 21 CFR Part 11 provides best practices for securing and managing electronically generated data and authentication of users, specifically in pharmaceuticals, biotechnology, medical devices, and other life sciences organizations. It ensures that electronic systems of storing, processing, and transmitting data meet strict security, integrity, and traceability standards.  Additionally, it defines software product vendors' and IT departments' roles and responsibilities in protecting and backing electronic records and signatures.  This regulation eventually protects businesses from malicious attacks, unauthorized access, and accidental data destruction. 

Related Read: How Flosum Helps in Salesforce 21 CFR Part 11 Compliance.

Data Integrity and Security for 21 CFR Part 11 Compliance 

To ensure data integrity, life sciences organizations involved in data collection and reporting must adhere to the guidelines and processes stipulated in 21 CFR Part 11. The key aspects include data integrity, authorized access management, unique electronic signatures, record retention, system validation and maintaining audit trails. 

Managing data integrity is essential for the following reasons.

. Reliable Decision-Making and Ensuring Regulatory Compliance

Data integrity indicates an organization's data's accuracy, completeness, consistency, and validity throughout its lifecycle. It is important because it helps organizations protect sensitive information, make reliable decisions, and comply with regulations. 

. Ensure Patient Safety

Data integrity and security are critical in the pharmaceutical and life sciences industry to ensure patient safety. If data integrity is not maintained, unsafe or ineffective drugs and faulty devices can enter the market, compromising patient safety. 

. Prevent Financial and Reputational Loss

Additionally, it can lead to financial losses for the organization due to product recalls, regulatory fines, halted production, and reputational damage. Maintaining data integrity and security safeguards ensures high-quality products and upholds the ethical and legal standards of the industry.

Importance of Salesforce Data Back and Recovery for 21 CFR Part 11 Compliance

Salesforce's CRM helps organizations track interactions with healthcare professionals, manage leads, and analyze sales data. At the same time, other cloud-based solutions enable organizations to remotely access critical information, facilitate collaboration among sales teams, and improve overall efficiency.

Robust Salesforce release management, data backup, and security solutions can help your organization comply with 21 CFR Part 11 backup regulations. And, your organization's ability to backup and restore Salesforce data quickly and without errors is paramount to prevent costly downtime. 

If you fail to do so, your organization becomes vulnerable to data loss or corruption in the event of an error or malicious attack.

As the Salesforce platform is an integral part of the pharmaceutical and life science companies' business, make sure to  implement a powerful Salesforce backup and recovery solution to comply with the regulations. 

Salesforce Backup and Restore Solution

A quality Salesforce backup and restore solution should provide you with high-level control over who has access to your data and when they have access. Organizations can manually create backups or periodically schedule them using Salesforce native or dedicated third-party backup solutions. However, in order to back up and retrieve salesforce data, you must follow a methodological approach highlighted below. 

Manage Data Retention Policies 

Salesforce data retention policies determine the duration for which different data types are stored in the Salesforce platform. Data such as emails, tasks, and events on the platform have a default retention period of six months. 

The platform also retains audit logs, including login history and API usage, for 6 months. The data are archived after their default retention period. Depending on business and regulatory requirements, you can customize data retention periods for different data types. 

Overall, data retention policy helps you retain data as required by regulations and delete data that does not have business value.

Salesforce Native Backup Solution

Salesforce data backups generate files of your organization's CRM data in comma-separated values (CSV) format. Salesforce provides multiple basic built-in options for data backup and recovery.

• Data export allows users to manually export data and schedule at predefined intervals, depending on the license type. 
• A data loader is a client application for bulk data import or export via API. The loader enables organizations to bulk back up Salesforce records. 
• As a third option, organizations can use reports for manual on-demand data export for backup.  

Salesforce also offers a comprehensive paid add-on backup solution that enables organizations to easily set up and configure their backup policy. For instance, the enterprise solutions provide automated backups, including metadata, and allow easier data restoration. 

Salesforce data backups take place automatically once every 24 hours starting at 5:00 PM Central Time. Organizations can also set a custom backup schedule and choose a start time and preferred time zone. Also note that you can change your backup schedule at any time according to your requirements.

However, it's important to remember that while native Salesforce backup solutions are flexible, their customization options and scope may be limited compared to third-party tools.

Salesforce Third Party Backup Solutions

It has become critical to  complement Salesforce native data backup solutions with third-party data backup and recovery tools to ensure critical business data is secure and recoverable.

Third-party backup solutions offer organizations flexibility, granularity, and automation. They also provide frequent and customizable backups, enabling organizations to limit data loss in line with their Recovery Point Objective(RPO). 

The solutions' advanced features, like metadata backups, versioning, and point-in-time recovery, enable seamless restoration of both data and configurations. These features are worth considering since the native Salesforce backup solution does not offer metadata backup, without which it won't be easy to correctly link the recovered data to its respective objects and fields. 

To complement Salesforce native data backup, you can use Flosum as your go-to solution. Flosum offers a reliable and efficient choice for comprehensive data backup, offering better disaster recovery and business continuity. 

Read: 5 Easy Ways To Improve Salesforce Data Backup Recovery Strategy.

Conclusion 

An automated and properly configured data backup and restore solution is essential for organizations looking to comply with 21 CFR Part 11 backup and other security and compliance standards. It enables you to protect your sensitive data and securely store and back up it.

The key to success is an enterprise-grade release management, data backup, and security solution that can adapt to your organization's specific needs. You can leverage Salesforce native or dedicated third-party backup solutions for securely storing and retrieving data, ensuring compliance with 21 CFR Part 11. It's also important to consider the scalability of your Salesforce backup solution. Ensuring that your backup and restore system can grow alongside your business and preventing downtimes and data loss caused by out-of-scale systems should be a priority.

A data backup tool like Flosum has built-in compliance with 21 CFR Part 11 backup that automatically tracks and reports on every record and signature across your software delivery pipeline, giving you complete control over compliance. Schedule a call to learn more.

Frequently Asked Questions

1. What are 21 CFR Part 11 Requirements?

21 CFR Part 11 establishes the criteria for electronic records and signatures in FDA-regulated industries to be considered trustworthy, reliable, and equivalent to paper records. It consists of three subparts, with the first subpart A outlining general provisions. Subpart B focuses on electronic record integrity, security controls, and retention, while Subpart C addresses electronic signature requirements, including unique identification and security measures. 

2. What are the ICH guidelines 21 CFR Part 11?

The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines result from collaboration between the pharmaceutical industry and regulators. The guidelines help pharmaceutical and life science companies with product development and quality control. 

ICH guidelines 21 CFR Part 11 focus on ensuring the integrity and reliability of electronic records and signatures in FDA-regulated industries, specifically pharmaceutical and life sciences. The guidelines require organizations to implement robust controls to manage electronic records, including system validation, audit trails, and security measures to ensure the authenticity of data.