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Choosing the right electronic Quality Management System (eQMS) is a technological decision but also a strategic partnership that can help to bring products to market safely, efficiently, and at scale. We’ve spent decades building ACE alongside the world’s leading pharmaceutical, biotech, and medical device companies. Today, some of the largest life science companies in the world trust ACE for their quality management and compliance needs.
But what makes ACE different? It comes down to four foundational pillars that define who we are and how we serve the life sciences community: Expertise, Innovation, Partnership, and Trust.
PSC Software is a division of PSC Biotech, one of the world’s largest specialty life sciences consultancy firms with 1,000+ clients across 50+ countries. Our team includes quality professionals, regulatory experts, and validation specialists who understand the intricate requirements of FDA, ISO, GxP, and global regulatory frameworks because they’ve implemented them firsthand. This means that when clients work with PSC Software, they’re getting decades of accumulated regulatory knowledge built directly into their quality management system.
ACE is specifically designed to meet the stringent performance, validation, and security requirements of highly regulated industries. Every release undergoes thorough testing and validation, providing clients with a comprehensive update package that significantly minimizes their validation workload.
For clients seeking a turnkey solution, ACE Essentials comes pre-validated with ready-to-use workflows and SOPs for instant compliance with 21 CFR Part 11, ISO 13485, and other critical standards. This package, along with fast implementation, means clients can achieve regulatory readiness in weeks, not months, avoiding expensive implementation consultants or lengthy validation cycles.
ACE includes features specifically engineered for regulatory readiness: secure electronic signatures, comprehensive audit trails, version control, and real-time notifications. Every action is automatically recorded with time-stamped logs, providing a complete history for compliance audits and ensuring accountability across your organization.
When auditors arrive, clients have confidence knowing their quality data is organized, traceable, and instantly accessible, exactly as regulators expect. PSC Software customers consistently report smoother inspections and faster audit cycles because ACE keeps their quality documentation audit-ready 24/7.
While many eQMS platforms are just beginning to explore artificial intelligence, ACE Intelligence is already transforming how life sciences companies manage quality. Built directly into the ACE platform, this advanced AI capability leverages a secure environment, ensuring both cutting-edge performance and enterprise-grade security.
ACE Intelligence empowers your team to:
At the heart of ACE is its low/no-code configuration capabilities. Unlike rigid systems that require expensive consultants for every workflow change, ACE allows client teams to design processes tailored to organization needs and configure workflows, forms, permissions, and reports without writing complex code.
This means you can:
What sets PSC Software apart is that we’re not just a software vendor. As part of the PSC Biotech family, we bring the perspective of a global consultancy that provides CQV, CSV/CSA, auditing, metrology, and comprehensive quality services to thousands of life sciences companies worldwide.
We understand client challenges because we’ve solved them across the industry—from startups seeking their first ISO 13485 certification to global enterprises managing complex multi-site operations across dozens of countries. This real-world experience informs us of the features we build, the workflows we design, and every client relationship we cultivate.
PSC Software offers comprehensive validation services, implementation support, and training to ensure client teams are confident and productive from day one of using ACE. Our validation experts develop tailored validation plans aligned with FDA Computer Software Assurance (CSA) guidance, perform thorough IQ/OQ/PQ testing, and provide audit-ready documentation that demonstrates compliance.
We believe in transparent customer relationships and delivering solutions that are both effective and cost-efficient. ACE is available as a complete package for clients that would like to avoid module expansion. Additional modules can be added as users gain familiarity or need new processes to support them.
PSC Software customer success stories demonstrate the partnership experience and measurable results ACE delivers:
These are long-term partnerships where we’ve walked alongside our clients through inspections, expansions, and the ever-evolving regulatory landscape.
When some of the top pharmaceutical companies in the world choose ACE for enterprise quality management functionality, it shows that they trust our platform’s scalability, reliability, and enterprise readiness.
These global organizations selected ACE because it delivers:
ACE is built on a proven, secure cloud network that meets the rigorous security requirements of life sciences companies. ACE provides fully configurable permissions ensuring users can only access, edit, or view data relevant to their roles, enhancing data security and supporting compliance.
PSC Software maintains a dedicated focus on data privacy, system availability, and best-in-class network, application, and data-level security to protect sensitive quality information. Every system update, every security patch, every infrastructure enhancement is performed with current regulatory requirements in mind.
PSC Software combines decades of industry expertise with cutting-edge technology to support clients in advancing global health and safety. Through the ACE platform and our relentless focus on customers, we bridge the gap between complex regulatory demands and operational efficiency, enabling teams to work smarter, drive innovation, and improve health and safety outcomes worldwide.
Our vision is to empower regulated organizations with innovative, reliable, and customer-focused software solutions that simplify compliance. This is foundational to everything we build, every relationship we cultivate, and every customer we serve.
Schedule Your Personalized Demo See how ACE can transform quality operations with a tailored demonstration focused on business specific needs and regulatory requirements.
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Get answers to your questions and discover how ACE can help you elevate your business.
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