Celltrion Global Safety Data Center Inc. (CGSDCI) is a post-marketing surveillance company that handles the post-marketing surveillance of Celltrion products and serves EU countries, Australia, and Health Canada. CGSDCI ensures that data integrity handling procedures are followed, and it is a legal requirement to comply with the EMEA standards that promote data integrity. To ensure that all documents are signed and that data integrity handling procedures are followed, CGSDCI uses a Quality Management System (QMS) that is both an internal and regulatory standard.
In response to the pandemic, CGSDCI transitioned to a hybrid work model that included both home and office-based settings. This change prompted the company to search for an e-signature platform that could uphold its QMS and data integrity standards, as well as ensure the continuity of its processes and standards. CGSDCI ultimately selected Twala, a Philippine-based e-signature platform that provides a secure and reliable solution that aligns with the company's regulatory and data-driven objectives.
Aileen, the Quality Assurance Assistant Manager, and team lead, ensures that the QMS follows the regulatory standards, and all documents are up-to-date, all regulatory standards, audits, and partner regulations are met. The QA team caters to every workflow within CGSDCI and bridges external parties such as Korean colleagues, QPV colleagues, and other partners.
CGSDCI's top priority is meeting the needs of its partners, which include generating reports, creating procedures, and producing documents that interface with other services, while ensuring that all outgoing documents are verified for accuracy. However, the company faces several obstacles in fulfilling these requirements, such as poor internet connectivity, partners' inability to deliver the necessary components, and QMS delays. These QMS delays can manifest in a variety of ways, such as the non-provision of documents,delays in document signing, and errors in the platform used to manage these documents.
CGSDCI considered other alternatives, such as Docusign andGlobal Sign. However, the team chose Twala because it is a Philippine-based company that offers a secure and safe platform and is at par with the company's regulatory and data-driven goals. Twala helped CGSDCI establish its quality management system, generate standard operating procedures, work instructions, and deviation reports. Twala ensures that every document is signed, reviewed, and approved as per the company's procedure.
CGSDCI rates Twala's impact as follows:
eSignature impact: 100%
Turnaround time impact: 75%
Cost impact: 30% lower compared to other competitors of Twala.
By leveraging Twala's automation system, CGSDCI was able to incorporate esignatures and meet regulatory standards for its QMS, including maintaining an audit trail. Twala's customer support team provided invaluable assistance to CGSDCI, resolving any issues that arose in a timely and effective manner. Additionally, Twala's cost-effectiveness and robust security measures, which align with CGSDCI's regulatory and data-driven objectives, made it the preferred e-signature platform over its competitors.