Life sciences companies must validate any computer systems that impact product quality or patient safety. GxP guidelines require them to keep this software in a validated state for its entire life cycle.
The good news is that the validation industry is working toward approaches that reduce effort and are FDA-acceptable. These improvements allow life science organizations to reduce documenting cycle times, achieve greater efficiencies and visibility, and maintain data integrity.
Managing all validation activities through a paper process opens life science organizations up to potential human errors, data integrity issues, unnecessary audit findings, compliance issues*, and high documentation cycle times. In the highly demanding and regulated life sciences environment, an integrated software application that automates many of these manual processes can improve operational efficiency and increase accountability and visibility.
With the push towards Industry 4.0 and Pharma 4.0, life sciences companies are expected to embrace digital transformation across all aspects of their business. However, the adoption of new technologies is often stalled by life sciences companies’ inability to validate or test upgrades to critical systems.
Validation of computer systems is essential to the life sciences sector. FDA-regulated industries must validate all systems that directly or indirectly impact product quality, patient safety, and healthcare. Whether it’s 21 CFR Part 11 validation to ensure the accuracy, reliability, availability, and integrity of records or warranty of the software used in medical devices for quality and manufacturing purposes, these activities are time intensive and require significant resources.
A life sciences validation software can help streamline these processes by providing the ability to track documents in an easy-to-search system that can quickly offer historical versions of all critical documentation when requested by regulators during inspections and audits. By moving from a document-based approach to a more digital system, life sciences companies can save time and resources to refocus efforts on adding value to patients.
Regulatory requirements require that life sciences companies validate computer systems to ensure they are fit for their intended use. It means that any software used in producing medicines, medical devices, and other healthcare products must undergo rigorous and extensive testing before being deployed within the company.
With so many factors at play, validation efforts must be streamlined to minimize risk and allow teams to focus on other critical business goals. For example, a digital validation system can automate processes and reduce documentation time, making it easier for teams to get drugs and medical devices to market faster.
A digital validation solution also helps to mitigate risks and improve the quality of products and services by reducing the number of errors and discrepancies in data. It, in turn, can help lower costs and prevent costly recalls. The best life science validation solutions are those that maximize the use of your team’s valuable time and skills. These life sciences digital validation solutions are scalable and can quickly adapt to changing needs and business objectives.
Suppose you’re considering a life sciences digital validation solution. In that case, finding an experienced partner with a firm grasp of the industry and knowledge of how to implement best practices for biopharma and life sciences manufacturers is crucial. Look for a vendor that provides a single point of contact for support and collaboration. This way, you can rest assured that your most valuable resource is being put to the best possible use—rather than split between multiple people.
As life sciences companies strive to keep their competitive edge, they must also meet the increased demands for technological solutions. Robust validation software must support These systems and processes, which helps ensure they are working as intended. It, in turn, minimizes the risk of non-compliance with GxP standards and protects the company’s commercial growth.
The FDA requires that computerized systems that directly impact product quality, patient safety, or data integrity be validated to the highest degree possible – with validation performed at every stage of a system’s life cycle. It includes methods that create electronic records and signatures for regulatory filings. USDM offers validation services to help life science companies with critical components, including system testing, review, and documentation.
During the validation process, it’s essential to consider a risk-based approach that allows engineers to focus on areas of the system that are considered high-risk. It will enable the company to reduce testing efforts in other sites deemed lower risk.
Lastly, when selecting life science validation software, it is critical to consider the vendor’s level of industry expertise and pre-built validation documentation. Some vendors provide documentation that is tailored to the specific needs of the life science industry. In contrast, others may need to gain life sciences experience or offer manual test scripts and expected results.
The search for new technological solutions has intensified, with life sciences companies needing help to balance commercial growth and regulatory compliance. These solutions must manage validation processes and reduce the risk of non-compliance with GMP standards — while protecting the company’s commercial development.
Historically, the FDA requires that any computer system that directly or indirectly impacts product quality and patient health and safety undergoes rigorous validation. The process is lengthy, with wet-signature approvals needed for each step. The resulting burden of paper-based documentation and long maintenance periods creates tech debt that puts the life sciences industry at risk.
However, new technologies are helping to improve how regulated companies validate their systems. For example, paperless systems allow for standardized templates that help to reduce training/retraining time and the need to review and approve documents. Additionally, cloud-based systems with ongoing monitoring and maintenance schedules help minimize management overhead while ensuring the system is always running.
Even more, some vendors understand life science organizations’ challenges regarding validation and are helping them make significant strides toward lower-effort, FDA-accepted validations. For instance, many vendors provide automated validation scripts to simplify the testing of a software application and ensure that the system is fit for the intended use. It helps to speed up the process significantly and enables life science companies to save on costs.