Case Study: Ascentage Pharma achieves regulatory compliance, IP protection and improved efficiency with OpenText Documentum for Life Sciences

Ascentage Pharma meets compliance requirements with OpenText

Ascentage Pharma, a clinical‑stage biopharmaceutical company in Suzhou developing small‑molecule therapies for cancer, hepatitis B and age‑related diseases, faced growing compliance and IP risks as it expanded. Reliance on paper, local file shares and email for SOPs and approvals made tracking difficult and threatened adherence to regulations such as FDA CFR 21 Part 11, so the company needed a scalable, secure and auditable document management solution.

Working with Shanghai Zonysoft, Ascentage implemented OpenText Documentum for Life Sciences (with Documentum for Quality & Manufacturing and Brava! for collaboration), rolling it out in the quality department with about 200 users. The solution delivered built‑in industry best practices and CSV support, improved approval efficiency, secured intellectual property with strict access controls and audit trails, reduced paper use, ensured regulatory compliance and set the company up to expand Documentum across the business.

Ascentage Pharma

Leo Sun

Associate IT Director