Life science companies face a complex set of compliance expectations. These companies must follow GxP guidelines and FDA regulations, especially regarding computer system validation (CSV), from pharmaceuticals to medical devices.
CSV is one of the most essential processes for ensuring quality and safety in the life sciences industry. Many businesses use a traditional paper-based approach to managing software validation.
Process Documentation
Life sciences companies need to validate every computer system that touches regulated processes. This translates into hundreds, if not thousands, of documentation documents that need to be created, shared, and approved. This process is complex and resource intensive. A life sciences validation software solution can simplify the process.
A digital validation system can help eliminate the manual processes that are inefficient and error-prone. This approach also reduces the time it takes to review and approve documents. It can also be used to automate the testing of computer systems. This can reduce the need for physical inspections and save time and money.
To comply with 21 CFR Part 11, any life science business that uses a computer system for regulated processes must ensure that the software meets the FDA’s requirements. This includes ensuring the software can submit data to regulatory agencies electronically and handle product recalls as needed.
Regulatory compliance is essential for all businesses, but especially in life sciences. This industry demands strict standards and regulations to protect patient safety and maintain plant efficiency. This means that the right validation software can help to make the difference between success and failure.
When considering a validation software solution, look for a vendor with validation modules ready to use and customizable for your specific needs. This will help accelerate the validation process and ensure all document templates meet your compliance requirements.
Electronic Signatures
A life sciences business that relies on GxP-compliant software systems needs to ensure those systems are valid. The validation process involves establishing documented evidence that a specific, computerized system tool can be used in a manner that meets the intended purpose and quality requirements.
That’s why a life science company needs to look for validation-as-a-service solutions that eliminate manual, time-consuming paper processes and help teams work more efficiently. A validation-as-a-service solution can speed up the documentation, execution, and distribution of all required validation, quality, and compliance documents.
That reduces the overall burden on the team, helps avoid regulatory delays, and ultimately improves business operations and efficiencies. It’s also good for life sciences businesses to seek validated e-signature solutions that provide flexibility and security.
Generally, any software system directly impacting product quality or patient safety must be validated. That’s because GxP guidelines – as well as FDA regulations – require that there is consistency, reliability, and traceability throughout the entire manufacturing process. In the case of pharmaceuticals or medical devices, a defect could have serious health consequences. Fortunately, the industry is progressing in the quest for more reliable, less resource-intensive computer system validations. Some vendors, for example, offer turnkey solutions pre-configured for validation with an approach called CSA (Computerized System Validation).
Traceability
For life sciences businesses, traceability is critical to their software systems. It helps them identify problems and manage recalls quickly and effectively. Traceability also makes it easy to analyze a root cause when a problem arises. This analysis identifies which process or system is responsible for the issue, which allows for rapid improvements to be made that reduce the risk of future defects or product recalls.
A validation support package is essential for software used in producing pharmaceuticals, medical devices, and biotech products. A key gauge is whether the vendor offers pre-built validation documentation. If they do, that may indicate that they don’t consider this a core aspect of their business or that they need a strong enough level of expertise to be competitive in the life science space.
Life sciences companies require paperless, GxP-compliant systems that make managing validations’ complex tasks more manageable. These systems help them standardize processes and automate many manual tasks, making them more efficient than traditional paper-based systems. Additionally, these systems are designed to be easily updated when a company’s requirements change, which helps them reduce the time it takes to validate new software. They also offer features that enable them to maintain compliance with regulatory agencies even as their systems evolve and expand.
Automated Testing
A pre-configured turnkey solution for validation can make the process faster and less costly. When choosing a validation system, look for one with built-in automated testing scripts to speed up the process.
Automated testing can also reduce the need for manual testing during software upgrades. This can be a significant benefit for life science businesses that struggle to balance revalidation demands with the need to upgrade their software to keep pace with industry standards and stay competitive.
Another critical feature of validation software is ensuring it enforces the consistent processes a life sciences company outlines as part of its larger FDA software validation plan. This includes ensuring that workflows that require approval are strictly enforced and that master data has timestamps and user access logs. It also ensures that any changes made to the software follow Good Manufacturing Practices (GMP) and are logged in an audit trail.
