Streamline GxP workflows in one controlled environment and say goodbye to paper and binders.
Is your life sciences organization bogged down by antiquated paper-based workflows? Are you plagued by inefficiencies, errors, and compliance risks? Are you ready to transform how processes are documented and monitored?
Bearing the Burden of Paper-Based Processes
Traditionally, GxP processes like quality management, application lifecycle management (ALM), and manufacturing operations have relied heavily on paper-based workflows and manual documentation that are:
- Error-prone: Human error is inevitable when relying on manual data entry and processing. Misplaced documents, illegible handwriting, and transcription mistakes can compromise data integrity and regulatory compliance.
- Time-consuming: Searching through stacks of paper documents is a laborious task that consumes valuable time. Additionally, the manual routing of documents for approvals and signatures slows down cycle times, delays decision-making, and extends project timelines.
- Compliance risks: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), impose stringent requirements for data integrity and traceability. Paper-based systems often struggle to meet these standards and increase the risk of non-compliance and regulatory sanctions.
Adopting Paperless Validation
Paperless validation is a significant shift to how life sciences organizations approach GxP process validation. By leveraging ProcessXLM, you’re able to transition from traditional, document-heavy validation activities to an automated and streamlined approach using ALM, validation lifecycle management (VLM), and automated regression testing.
ALM manages the life of an application from initial planning through development, deployment, maintenance, and retirement. It integrates people, processes, and technology to ensure that applications are delivered efficiently, meet business requirements, and are maintained effectively throughout their lifecycle. ProcessX ALM tools empower your teams to onboard new systems, track requirements, make changes, and view system status from inception to retirement.
Implementing Low-Code/No-Code Citizen Development
The collective knowledge and creativity of citizen developers empowers your organization to reduce costs, increase operational efficiency, and eliminate manual processes. A low-code/no-code platform like ProcessX equips citizen developers to quickly build practical and useful workflows.
Strategies for implementing citizen development—and AI citizen development in particular—include:
- Thorough testing and validation to help prevent data breaches, unauthorized access, and other security concerns.
- Detailed records of your development processes, testing results, compliance maturity, and user feedback to facilitate continuous improvement.
- Regular reviews to ensure that you update Standard Operating Procedures (SOPs), Work Instructions (WIs), and governance frameworks to reflect changes in technology, regulations, and business objectives.
Embracing Automation for Process Optimization
Adopting automation lays a pathway to overcome the limitations of paper-based processes and drive efficiency in your life sciences organization.
For example, automation decreases labor costs by handling repetitive tasks, minimizing the need for manual data entry, and avoiding human error and rework related to manual data entry and paper handling. And it significantly reduces printing and paper usage, which contributes to your corporate sustainability efforts.
In addition to greater efficiency and cost savings, benefits of moving from paper-based to automated GxP processes include:
- Compliance and Data Integrity. Automated systems ensure that procedures are followed consistently, which is critical for GxP compliance. Electronic systems establish better audit trails for easier record retrieval, which is essential for regulatory inspections.
- Data Management and Accessibility. Automated systems often store data in centralized databases for easier access and analysis. They also allow for real-time data collection and monitoring that leads to better decision-making and responsiveness.
- Scalability and Flexibility. Automated systems easily scale to accommodate growing volumes of data and process complexity. They can be adapted and reconfigured to meet changing regulatory requirements and business needs.
- Quality Control. Automated systems typically include built-in quality control checks to ensure quality and consistency in outputs. Automated continuous monitoring quickly identifies and addresses issues to reduce the risk of non-compliance.
- Security and Disaster Recovery. Electronic systems often have advanced security features—such as encryption and access controls—to protect sensitive data. Backup and disaster recovery solutions protect data from loss or damage.
Get Started Today!
By transitioning to automated processes, organizations can improve their operational efficiency, maintain compliance with regulatory standards, and gain a competitive advantage in the industry.
Any time is the right time to streamline your processes and improve your operational efficiency. Contact us to learn how ProcessX supports paperless validation for a variety of systems, including:
- Enterprise GxP systems
- Analytical instrument systems
- Manufacturing equipment and software
- Automation systems
