Ensuring quality control and compliance
Ascentage Pharma achieves compliance and efficiency gains with OpenText
How does an emerging pharmaceutical company manage rapid growth, protect its intellectual property (IP) and comply with strict regulatory requirements?
Ascentage Pharma turned to OpenText™ Documentum for Life Sciences™.
Ascentage Pharma is a clinical-stage biopharmaceutical company that aims to improve the lives of patients. The company is pioneering a new class of medicines to address the most difficult-to-treat diseases, such as cancer, hepatitis B and age-related diseases.
The company had placed a heavy reliance on physical paper documents, locally stored files and email for its standard operating procedure documents and approvals. But following a period of rapid growth Ascentage needed a scalable, secure and compliant system to protect its intellectual property, streamline processes and adhere to strict regulatory frameworks, including FDA CFR 21 Part 11, when storing its electronic records and signatures.
Based on the outstanding reputation of the solution, global presence and the large number of implementations in the pharmaceutical and wider Life Sciences market, OpenText was a clear winner.
Without the OpenText Documentum for Life Sciences solution, we would not be compliant and this would impact our ability to take new products to market. We have great confidence that the solution will meet our needs in the future too, as we grow, said Leo Sun, Associate IT Director, Ascentage Pharma.
With around 200 staff already benefitting from the solution, the firm’s primary objectives of compliance and efficiency have been met. Ascentage Pharma is also using:
- OpenText™ Documentum™ for Quality and Manufacturing to ensure compliance, and
- OpenText™ Brava! For Documentum™ D2 to enable greater collaboration among staff. For example, documents can be easily annotated and sections can be redacted to protect sensitive information.
Ascentage Pharma recently worked with us on a Success Story to describe their scalable and secure solution. Read the full success story here.
