September 2024
In the world of regulated industries, maintaining compliance with Good Practice (GxP) guidelines is crucial. Salesforce, a powerful cloud-based platform, is increasingly being used by companies in the pharmaceutical, biotechnology, and medical device sectors. Ensuring that Salesforce is GxP compliant is vital for these organizations to meet regulatory standards and safeguard data integrity and quality.
Why Salesforce Needs to be GxP Compliant
The Salesforce platform provides a great starting point from an IT and compliance perspective as it already has some of the built-infunctionalities required by regulated companies. However, it does not provide Salesforce verification or validation documentation as required by the regulators and as expected by regulated companies.
Regulatory Requirements
The main regulatory requirements are 21 CFR part 11, EudraLex 4 Annex 11 and ISO 1385, this requires that any system that affects GxP process needs to be validated to ensure it consistently produces reliable and accurate data. For organizations using Salesforce, this means implementing robust validation processes to demonstrate compliance.
Ensuring Data Integrity
In regulated industries, maintaining data integrity is of utmost importance. Salesforce holds critical data that can impact product quality and patient safety. Ensuring that Salesforce is validated and compliantwith GxP guidelines ensures that data is accurate, complete, and secure throughout its lifecycle.
Risk Mitigation
Validating Salesforce helps mitigate risks associated withsystem failures, data breaches, or compliance lapses. By ensuring thatSalesforce meets GxP standards, organizations can reduce the likelihood ofregulatory warning letters ,product recalls, or damage to their reputation.
When to Validate Salesforce
Companies that manage product related processes on their Salesforce platform, being standard or custom processes, are required to assessand, if necessary, validate these processes for every release of Salesforce and/or partner application.
In some cases, a third-party vendor of a Salesforce application may provide the initial validation package of their app or service, but the on-going validation and assessment of each release is ultimately the responsibility of the customer and usually requires additional planning andresources.
Implementation Phase
Validation should begin during the implementation phase of Salesforce to ensure that the system is designed and configured to meet GxP requirements. Early validation helps identify potential compliance issues and allows for necessary adjustments before the system goes live.
System Upgrades and Changes
Any changes to the Salesforce computer system, including upgrades, customizations, or integrations with other applications, trigger’s avalidation process (risk assessment of the changes). This ensures that modifications do not adversely impact the system's compliance status or dataintegrity.
Periodic Review
Regular reviews and revalidation of Salesforce are essentialto maintain compliance over time. As regulatory requirements evolve,organizations must ensure that Salesforce continues to meet the lateststandards and guidelines.
How to Validate Salesforce for GxP Compliance
To validate the Salesforce platform, customers should firstdefine the rationale and processes which require validation in theirenvironment. The next step would be engaging an internal or external resourcewho can provide the expected assurance that the process is working asspecified.
Leverage Automation for Validation
As highlighted in the article "Increasing Software Quality and Accuracy Using Automation," automation can play a significant role in streamlining the validation process. Automated testing tools can help ensure consistent and thorough validation of Salesforce, reducing the likelihood of human error and improving efficiency. Automated document management systems can help maintain up-to-date validation records and audittrails, crucial for GxP compliance.
Continuous Monitoring and Maintenance
Implement continuous monitoring of Salesforce to detect and address potential compliance issues promptly. Regularly review and update validation documentation to reflect changes in the system or regulatory requirements.
Conclusion
Salesforce is a powerful tool that can enhance business operations in regulated industries. However, ensuring that Salesforce is GxP compliant is essential to meet regulatory standards and protect data integrity. By implementing a robust validation process and leveraging automation,organizations can ensure that Salesforce consistently meets GxP requirements, reducing risks and enhancing product quality.
As the regulatory landscape evolves, staying informed about the latest GxP guidelines and best practices is crucial. By prioritizing compliance and validation, organizations can leverage Salesforce to drive innovation and success while maintaining the highest standards of quality andsafety.
About Validify
Validify is a riskand validation management platform designed to provide customerswith an advanced tool for IT risk assessment and software validation. The platform was designed to automate a significant part of the risk assessment maintenance to support continuous validation process, as well as automated and customizable template-based validation document generation. Validify also provides a built-in connector for the Salesforce Platform, providing real-time status of your Salesforce compliance and identifying changes in your org automatically.
About the author
Ido Raz - Founder and CEO of Validify
Ido Raz is the co-founder and CEO of Validify. Ido has extensive experience in providing solutions for organizations in the life sciences and other regulated industries. He led global technological and implementation teams, specializingin providing IT compliance and quality applications. He is an experienced compliance and cGMP professional and a cloud technology enthusiast.
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