Adhering to the principles of good manufacturing practice (GMP) is crucial for enhancing operational efficiency and upholding consistent product quality in businesses. In the life sciences industry, such as pharmaceutical manufacturers and medical device makers, GMP compliance is not only beneficial but also mandatory as per the regulations set by the FDA.
Compliance with FDA regulations 21 CFR necessitates the validation of processes followed by life sciences businesses. These regulations require businesses in the life sciences sector to adhere to GMP practices, maintain good documentation practices (GDP) to ensure product quality across the entire supply chain, implement good laboratory practices (GLP) to generate reliable test data, and follow Good Clinical Practices (GCP) to safeguard participant rights and data during clinical trials. Together, these practices are collectively referred to as GxP.
In accordance with FDA regulations for life sciences businesses, specifically 21 CFR part 11, validation is also obligatory for computer systems utilized in relation to GxP requirements. This validation encompasses SAP Business ByDesign, an Enterprise Resource Planning (ERP) system widely employed by numerous life sciences businesses today.
Understanding FDA Validation Process
The process of FDA validation involves demonstrating, on an ongoing basis, that a software system consistently meets all the FDA requirements regarding GxP. To achieve this, the validation process includes defining the necessary processes, conducting tests to ensure compliance with these process requirements, and documenting the processes and test results to provide evidence of the system’s satisfactory performance.
FDA validation is typically carried out by the life sciences business itself, and it is often verified by an independent validation firm, similar to how auditors verify financial records.
For a more detailed understanding of the FDA validation process, we recommend reading our blog post titled “How to Validate Software for the FDA.”
Validation During Implementation and System Changes
Life sciences businesses that utilize SAP Business ByDesign or other software for their operations must complete FDA validation before deploying the software in a production environment. Additionally, when significant changes or upgrades are made to the software, life sciences firms are required to re-validate it to ensure continued compliance with FDA regulations.
Fortunately, re-validation is not necessary for every software update. Minor updates that do not impact the existing processes within the software do not trigger re-validation. Only modifications to the software’s processes and functionality that could potentially affect compliance require FDA re-validation.
SAP Business ByDesign’s update rollout process helps alleviate the burden of FDA validation. The modular nature of Business ByDesign, along with configurable options, allows new features and updates that might alter processes to remain disabled until a business has tested and enabled the new functionality.
This grants life sciences businesses control over software updates, enabling them to assess the impact on processes before implementing them. By exercising this control, life sciences firms can avoid software updates that would necessitate re-validation.
Reducing FDA Validation Headaches with a Prepackaged Solution
Meeting the FDA validation requirements for software solutions set forth in 21 CFR part 11 requires the correct configuration of the software before testing and documentation. This often is where the cost and complexity come for software validation because incorrect configuration can lead to processes that don’t meet GxP requirements and require additional configuration work, testing, and verification.
Navigator’s prepackaged ERP solutions for life sciences businesses significantly ease this configuration burden. That’s because our prepackaged life sciences solutions come FDA validation-ready out of the box. The correct processes for meeting GMP requirements and FDA validation for a given life sciences business are already configured by default. So instead of having to configure SAP Business ByDesign from scratch to meet FDA validation mandates, a life sciences business can start with a system that is ready for validation.
This pre-configuration cuts the cost and time required to prepare for FDA validation, and it reduces the risk of validation failure. Many third-party validation firms also are familiar with our prepackaged solutions, which reduces the cost of verifying the system against FDA requirements. FDA validation and GxP adherence become a technicality instead of a headache.
By working with Navigator Business Solutions, life sciences firms also benefit from our deep experience with implementing systems that pass GMP and FDA process requirements. This includes our test-script library that represents the more prevalent functions in the manufacturing process for a life sciences business.
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