Scaling Compliance: CRDMO’s Startup to Success with ACE

This case study examines how a Contract Research, Development, and Manufacturing Organization (CRDMO), BioTechnique, needed a scalable and compliant electronic Quality Management System (eQMS) to ensure documentation integrity, operational training, and traceability from batch production and testing through release. Key user feedback from the manufacturing department highlights ACE’s configurability, document accessibility, and interface efficiency, which were critical benefits that supported early-stage operational scaling and compliance readiness.

To meet these requirements, the CRDMO deployed ACE, a cloud-based enterprise quality and compliance platform.  

The implementation included: 

1. ACE eQMS – Workflow automation and task management 
2. ACE Docs – Document lifecycle management 
3. ACE LMS – Role-based training and learning management 
4. ACE Analytics – Unified analytics and reporting

Use Case: Manufacturing Department Perspective 

An interview with a team member provided practical insights into ACE’s day-to-day impact. Their responsibilities included coordinating batch production, accessing historical records, and maintaining compliance with Good Manufacturing Practices (GMP). 

Challenges Avoided by Using ACE from the Start

The team avoided common startup inefficiencies by implementing ACE:

• Disorganized Documents: In companies not equipped with an eQMS, historical batch records are buried in shared cloud drives or unorganized document storage rooms, making retrieval time-consuming and error-prone. 

• Limited Customization: Legacy quality and organization tools lack user personalization or workflow integration features. 

• Inconsistent Role-Based Permissions: Access permissions were inconsistently enforced, posing compliance and data integrity risks. 

Benefits Realized with ACE 

️ Customizable Dashboards though ACE eQMS 

• ACE eQMS provided an intuitive, user-specific dashboard interface.

• User feedback complimented the ability to customize the dashboard to track project timelines, CAPAs, open tasks, and deviation reports.

• This enabled proactive task management, improving team coordination and individual productivity.

Controlled Document Access with ACE Docs 

• Batch records and SOPs were easily retrievable via the ACE Docs repository., which ensured that only relevant documents were editable to specific user roles, maintaining hierarchical access control.

• Compared to previous methods experienced by users (such as manual searching or searching PDFs on shared drives), this system enabled:

• • Faster retrieval time 

• • Reduced human error 

• • Improved GMP audit-readiness 

Multi-Device, Modular Architecture

• User feedback also praised ACE’s modular design and customizable user preferences.
• The system performed reliably across multiple devices (desktop, laptop, tablet), facilitating flexible use across different floors and offices.

Key Outcomes

• Efficiency Gains: Task tracking and document access improved operational flow within the manufacturing department.
• Enhanced Data Integrity: Centralized records reduced errors and manual file handling.
• Compliance Support: Role-based access and audit trails supported 21 CFR Part 11 and EU Annex 11 requirements.
• Scalability: ACE’s modular structure supports future growth, allowing the company to expand its usage across functions without system overhauls.

“Versatility and configurability are what I like the most about ACE compared to other eQMS platforms I used in the past. I am always learning about new ways to use ACE from the PSC Software team; just recently I learned how to configure my personal dashboard to better keep track of upcoming preventative maintenance for equipment and assets onsite. This lets me prepare by readying appropriate documentation. Using ACE Analytics, I can also see task status and efficiency. To be honest, this is really convenient and makes my day much more organized.”

-Christian K.

Manufacturing Technician, BioTechnique

The Impact of ACE 

ACE proved to be a strategic asset for Biotechnique by enabling structured growth without compromising compliance or efficiency. The combination of customizable dashboards, centralized document control, and modular, mobile-friendly infrastructure directly addressed the unique operational challenges of early-phase injectable production. This case highlights the value of user-driven configurability and integrated compliance in modern pharmaceutical manufacturing.