This article explores data backup and restore processes under 21 CFR Part 11, specifically for the Salesforce platform. Part 11 of Title 21 of the Code of Federal Regulations governs electronic records and signatures in regulated industries such as pharmaceuticals, life sciences, and healthcare. The regulation aims to ensure that electronic records are reliable, secure, and comply with the same standards as traditional paper-based systems.

21 CFR Part 11 mandates that systems managing electronic records meet specific criteria for record integrity, security, and accessibility. Robust backup and restore procedures are essential for protecting electronic records throughout their retention period. For organizations using Salesforce, implementing a compliant data backup and restore solution is necessary to meet regulatory requirements and safeguard data. This 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 and Restore Requirements

21 CFR Part 11 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 and requiring them to be readily available for inspection by the FDA.

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 up electronic records and signatures. This regulation ultimately protects businesses from malicious attacks, unauthorized access, and accidental data destruction.

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

How to Maintain Data Integrity and Security for 21 CFR Part 11 Compliance

To maintain 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 Regulatory Compliance

Data integrity indicates an organization's data 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.

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.

Prevention of Financial and Reputational Loss

Additionally, poor data integrity 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.

Why Salesforce Data Backup and Recovery Matters for 21 CFR Part 11 Compliance

Salesforce Customer Relationship Management (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. Your organization's ability to back up 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 pharmaceutical and life sciences companies' business operations, make sure to implement a powerful Salesforce backup and recovery solution to comply with the regulations.

Choosing the Right Salesforce Backup and Restore Solution for 21 CFR Part 11

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, to back up and retrieve Salesforce data, you must follow a methodological approach highlighted below.

Manage Data Retention Policies

Salesforce data retention policies determine how long 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 Application Programming Interface (API) usage, for six 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 built-in options for data backup and recovery:

• Data export allows users to manually export data and schedule exports 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. 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 will be difficult 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: 8 Easy Ways To Improve Salesforce Data Backup Recovery Strategy.

Implementing a Scalable 21 CFR Part 11 Backup Strategy for Your Organization

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

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 use Salesforce native or dedicated third-party backup solutions for securely storing and retrieving data while meeting 21 CFR Part 11 requirements. It's also important to consider the scalability of your Salesforce backup solution. Your backup and restore system must grow alongside your business and prevent downtimes and data loss caused by out-of-scale systems.

A data backup tool like Flosum has built-in compliance with 21 CFR Part 11 that automatically tracks and reports on every record and signature across your software delivery pipeline, giving you complete control over compliance. Request a demo with Flosum to learn how our solution simplifies 21 CFR Part 11 compliance for your Salesforce data.

Frequently Asked Questions

What are the 21 CFR Part 11 requirements?

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

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 sciences 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.

How often should Salesforce data be backed up for 21 CFR Part 11 compliance?

The frequency of Salesforce data backups for 21 CFR Part 11 compliance depends on your organization's RPO and the criticality of your data. While Salesforce native backups occur automatically once every 24 hours, many regulated organizations require more frequent backups to minimize potential data loss. Third-party backup solutions like Flosum enable customizable backup schedules, including hourly or real-time backups, to meet strict compliance requirements and reduce the risk of data loss between backup intervals.

What is the difference between Salesforce native backup and third-party backup solutions for 21 CFR Part 11?

Salesforce native backup solutions provide basic data export capabilities through manual exports, scheduled data exports, and data loader tools. However, these solutions have limitations, including lack of metadata backup, limited customization options, and longer recovery times. Third-party backup solutions like Flosum offer advanced features specifically designed for 21 CFR Part 11 compliance, including automated metadata backups, granular field-level recovery, point-in-time restoration, customizable backup frequencies, and comprehensive audit trails. These enhanced capabilities make third-party solutions better suited for regulated industries requiring strict data protection and rapid recovery capabilities.