Developing and manufacturing life-preserving medicines demands high-level production expertise combined with an unwavering focus on quality and safety. Defects and errors could lead to significant harm, and companies must adhere to strict regulations in all of the countries in which they operate.
This leading biotechnology company must assess each of the systems and processes powering its business activities. And for those systems directly or indirectly impacting patient safety, more stringent validation is required by regulations such as US FDA 21 CFR. A spokesperson comments: “We really do evaluate every single one of our systems down to the finest detail—from the software supporting our back-office activities all the way through every production system and the final packaging machines.”
With a presence in more than 100 countries, managing and monitoring testing is a complex operation, with regulatory standards varying in different jurisdictions. The company must not only conduct tests in line with regulatory standards, but also keep a detailed record of its testing activities to maintain full compliance.
To achieve this, a dedicated team conducts Computer Systems Validation (CSV) activities regularly to test, validate and document all the systems used by the company. At the start of the CSV assessment, the company determines which of the Good Automated Manufacturing Practices (GAMP 5) categories each system fits into, based on guidelines from the International Society for Pharmaceutical Engineering.
Once a GAMP 5 category is established, testers then begin the validation process to ensure that the system in question is fit for the intended use and meets the relevant regulatory requirements. This includes adherence to industry-standard ALCOA+ principles, which target data integrity with the goal of ensuring that the entire system is Attributable, Legible, Contemporaneous, Original, Accurate, plus complete, consistent and enduring throughout its lifecycle.
With hundreds of computer-based systems across its sites, managing testing cycles can be exceptionally time-consuming – not least because around 3,500 users are involved. The company found that its existing processes such as manually handling evidence and a physical signature process made managing and monitoring testing activities complex and cumbersome.
OpenText solutions reduce the time and effort associated with testing, and crucially help us to ensure that all of our systems, machines and manufacturing devices are functioning perfectly, helping us to maintain a great safety record and phenomenal quality.
Since deploying ALM/Quality Center (ALM/QC) more than ten years ago, the company has harnessed the software as a service solution to develop robust, rigorous and reliable testing and validation workflows from end-to-end.
At the start of the validation process, the company creates a master plan that defines the requirements that every system and machine must satisfy, with criteria differing depending on functional, regulatory, data, security, performance and infrastructure needs. Using the requirements module built-in to ALM/QC, testers then input these criteria into the OpenText solution and link each requirement with specific test sets.
Based on requirements in ALM/QC, testers use the OpenText test lab module to run initial assessments to determine a system’s GAMP categorization and whether or not it complies with good practice (GxP) and ALCOA+ principles. The team then creates installation and operational qualification documents, which detail how to determine if a system was installed correctly and whether it functions, operates and performs as expected.
To enhance testing efficiency, the biotechnology company integrated ALM/QC with UFT One to automate around 15% of the functional testing workload for its ERP software. Thanks to ALM/QC, testers can easily capture and attach evidence as they complete each test step, and submit defects on the spot, making manual testing much more efficient.
The company uses cloud versions of both OpenText solutions, which makes it easier to maintain version currency and reduces maintenance time and effort for internal staff. The latest version of ALM/QC supports single sign-on and includes enhancements to audit logging, both of which offer better support to regulated industries such as life sciences. For complete process visibility, testers use the OpenText solutions to link test scripts with run attachments and list defects alongside test sets and requirements.
Today, 3,500 employees monitor and manage hundreds of tests every week, managed by ALM/QC as a central digital record to provide a clear and comprehensive record of testing activities.
OpenText solutions make it really easy for us to share information with auditors as and when we need to.
With ALM/QC and UFT One the company has automated up to 15 percent of its functional testing workflows, with plans to achieve more.
“By setting up robust, standardized testing workflows for all scenarios, devices and systems and embracing automation, we’ve gained significant efficiency improvements in our testing cycles,” comments the spokesperson. “We can work faster, freeing more time for our teams to focus on higher-value quality control processes.”
ALM/QC makes it easy to re-use existing tests, saving time and effort, and provides at-a-glance visibility into testing status. The biotechnology company also values the traceability matrix in ALM/QC, which makes it easier to confirm that all requirements have been met and to identify changes in requirements when they occur.
Capturing GAMP5 categorization, ALCOA+ principles, test scripts, runs, defects, electronic signature validation and more, ALM/Quality Center now acts as the biotechnology company’s core platform for testing compliance.
“OpenText solutions make it really easy for us to share information with auditors as and when we need to,” comments the spokesperson. “We no longer need to trawl through paper documents, we can simply log into ALM/QC, select the test or workflow being audited, and all of the information we need is right there at our fingertips. We can also attach reports from ALM/QC directly to the final reports that we submit to regulators.”
The biotechnology company uses the OpenText e-Signature solution with ALM/QC to enable electronic signatures throughout the application lifecycle in requirements, backlogs, defects, tests, test plans, execution and pipelines. This makes it faster and easier for authorized approvers to sign off documentation. OpenText provides a dedicated support engineer for the e-Signature component
As it continues to develop its testing processes, the company aims to embrace more automation where possible.
The spokesperson concludes: “OpenText solutions reduce the time and effort associated with testing, and crucially help us to ensure that all of our systems, machines and manufacturing devices are functioning perfectly, helping us to maintain a great safety record and phenomenal quality. We’ve achieved this thanks to the support of OpenText, and we look forward to collaborating with them in the future as we refine and streamline our testing workflows.”