Milestone Pharma Co. Ltd, a holding subsidiary of WuXi AppTec, was established in 2016 and is committed to becoming a world-class drug quality control platform, providing one-stop solutions for drug-quality research aimed at drug registration. Milestone Pharma has built quality-control laboratories with different technical capabilities in Nanjing and Shanghai, in compliance with global pharmaceutical law and regulations.
Because Milestone Pharma is a key link in the pharmaceutical value chain, it is crucial for the company to maintain high levels of quality in every aspect of its operations. For drug development, and contract research in particular, the company must ensure that work is properly documented, reviewed and approved by its managers and subject-matter experts.
Yinyong, quality director at Milestone Pharma, explains, “The pharmaceutical space is evolving rapidly, driven by innovations such as mRNA technology and genomic medicine. While there are many new trends on the horizon, it’s certain that quality will continue to be the foundation of our industry, and we are committed to leading the industry in quality management.”
To help its clients bring life-enhancing therapies to patients, Milestone Pharma works closely with international pharmaceutical regulators to demonstrate that new drugs are safe and effective. These and business activities such as contract research generate huge numbers of documents, all of which must be made available to regulators.
In the past, Milestone Pharma relied on paper to drive its business. However, as the company grew, the time and effort to manage rapidly increasing document volumes rose substantially, reducing operational efficiency.
“The sheer quantity of paper records flowing back and forth across the organization was beginning to slow us down,” comments Yinyong. “For example, if a client requested an urgent change to a contract research order, the relevant paper record had to be updated, reviewed and approved by one or more managers. As we lacked a clear overview of where documents were in the approval cycle, it was difficult to identify and remove bottlenecks.”
To help its clients keep their projects on track, Milestone Pharma looked for a more efficient approach to document management. The aim was to empower employees to review and approve documents more effectively while ensuring a full audit trail for regulatory compliance and audits.
Thanks to digital workflows powered by OpenText Documentum, we can now process 3.5 times more documents each month, which creates headroom for significant future business growth.
Unify processes and seamlessly share information across the extended Life Sciences enterprise.
Control critical quality documentation, streamline and automate processes with compliance.
Milestone Pharma decided it needed to move away from paper and adopt a digital approach. The OpenText solution met the company’s core selection criteria, including the ability to enforce strict authoring standards around document taxonomies, attributes and access rights. Traceability and transparency were also crucial since Milestone Pharma would rely on document metadata to demonstrate compliance to regulators.
“During the solution evaluation process, one of the things that stood out to us was that pharmaceutical companies have been using OpenText Documentum solutions to support their businesses for over 20 years, and that gave us great confidence,” says Yinyong. “We conduct R&D and drug registration on behalf of large international enterprises, which means we must demonstrate our compliance with stringent quality standards. The OpenText solutions include templates based on global best practices—including from U.S. Food and Drug Administration and European Medicines Agency—straight out of the box.”
For Milestone Pharma, the move to paperless operations implied more than simply switching from written records to electronic documents. To build robust workflows around its digital documents, the organization turned to its trusted business partner, Tri-I Biotech Ltd.
“Tri-I Biotech are experts in delivering OpenText Documentum solutions for the pharmaceutical industry,” explains Yinyong. “Input from the Tri-I Biotech team was extremely valuable throughout the design and implementation process. For example, the team advised us on the optimal document taxonomies and helped us configure file attributes such as version numbers to track changes over the document lifecycle.”
Working with Tri-I Biotech, Milestone Pharma successfully transitioned to the new digital processes with zero disruption to day-to-day operations.“We were extremely pleased that we were able to move from paper processes to OpenText Documentum without interrupting mission-critical activities such as research or drug registration,” adds Yinyong. “Employees across the business found it straightforward to switch to digital documents, which allowed us to start realizing the benefits almost immediately.”
For compliance purposes, OpenText Documentum offers our regulators a transparent audit trail of every change to every document, including e-signatures.
Today, Milestone Pharma has significantly increased its document processing capacity without driving up back-office workloads. Yinyong elaborates: “Thanks to digital workflows powered by OpenText Documentum, we can now process 3.5 times more documents each month, which creates headroom for significant future business growth.”
“The solution is also making it easier for us to offer responsive services to our clients, since we’ve greatly reduced the risk of urgent approvals, such as change requests, getting lost in the shuffle. In fact, managers can even approve documents when they’re on the move, helping to avoid delays for our clients.”
By building its business on traceable digital workflows, Milestone Pharma has also reduced the time and manual effort required to prepare documentation for audits and certification processes.
“In the past, finding and retrieving paper records was a laborious and time-consuming process, but now that’s all changed,” says Yinyong. “We have a comprehensive set of attributes and metadata for each document, which makes it extremely fast and easy to find the records we need. And for compliance purposes, OpenText Documentum offers our regulators a transparent audit trail of every change to every document, including e-signatures.”
With OpenText solutions at the heart of its approach to digital document management, Milestone Pharma is in a strong position to drive growth while maintaining outstanding levels of quality across its operations.“Our journey with OpenText Documentum for Life Sciences and OpenText Documentum for Quality and Manufacturing is just beginning, but our clients are already starting to see the benefits,” concludes Yinyong. “Working with OpenText and Tri-I Biotech, we have deployed a digital document workflow that can support the most rigorous requirements of the pharmaceutical industry, helping our clients bring life-enhancing therapies to patients faster.”
Tri-I Biotech (Shanghai) Ltd is a high-tech enterprise focusing on digital empowerment construction in the life sciences industry.