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Overview
Manual data-handling protocols at a newly formed gene therapy research company were quickly getting out of hand. Though adequate for basic activities, the business’s storage and processes were inefficient and fell short on federal data compliance requirements.
Working with us brought them a robust, compliant IT infrastructure and innovation they can build on
Challenge
This life sciences company was experiencing significant difficulties managing and storing their clinical research and development data.
Their array of data came from multiple platforms like Box, SharePoint, and SFTP (secure file protocol) and included documents, white papers, studies, reports, diagrams, and imaging files from clinical trials, research, and government sources. Scientists and staff would manually store and work on the data in the company’s SharePoint repository. This approach was not only inefficient, it also failed to meet critical regulatory compliance requirements of FDA Title 21 CFR Part 2, which lays out stringent guidelines on data access, integrity, and documentation.
In short, their data management system was hindering their ability to effectively search, access, and analyze their data. They needed a better way to streamline document management and ensure compliance with regulatory standards at the same time.
Solution
From the beginning, we worked closely with the customer’s data analysis and clinical trial teams to review requirements and data sources so we could fully understand their specific needs.
To integrate with their existing Microsoft environment, we built our solution with the following tools:
- Azure storage – to provide robust capabilities and built-in Part 11 compliant readiness; includes file retention and enhanced auditing capabilities, ensuring documents remain immutable and tamper-proof.
- Power Apps – to provide a better way for research teams and analysts to process files; offers an intuitive user interface (UI) tool that enables data to be viewed, evaluated, and approved.
This combination of Azure and Power Apps tools supports auditing, workflow, and robotic process automation (RPA), while meeting the Part 11 compliance checklist. This includes:
- Systems validation
- Generation of accurate and complete copies of records
- Record protection for the duration of retention period
- Limiting system access to authorized users
- Secure, computer-generated, time-stamped audit trails
- Enforcing permitted sequencing of events
- Authority checks
- Device checks
- Personnel training
- Written policies for accountability
- Appropriate controls over systems documentation
- Controls for open systems
Our solution enables researchers at the company to process data much more easily. Previously manual, multi-step approval processes – from file selection to approval to email submission and more – can now be accomplished via automated workflow.
Additionally, we implemented tagging capabilities to address the sheer volume and size of files they work with. Our metadata tagging strategy enables scientists to categorize data and make it easier to search, retrieve and filter data.
The three primary solution components – moving the research and development data to a Part 11 compliant storage solution; making configured data more accessible and manageable with a custom user interface; and storing study files with metadata while maintaining FDA Title 21 CFR Part 11 compliance – resolved multiple complex data-handling issues and enabled our customer to continue their ground-breaking research activities with greater efficiency and effectiveness.
