Solutions

CDMO/CMO

In the highly regulated pharmaceutical industry, compliance is paramount. PSC Software®’s eQMS and inspection management solutions offer comprehensive tools for contract development and manufacturing organizations (CDMOs) to ensure they meet regulatory requirements while remaining efficient and competitive.

Solutions

CDMO/CMO

In the highly regulated pharmaceutical industry, compliance is paramount. PSC Software® offers comprehensive eQMS and inspection management solutions so that contract development and manufacturing organizations (CDMOs) remain both competitive, and compliant with ISO and FDA regulations. The integrated approach behind these tools ensures an efficient workflow that encompasses all quality processes from beginning to end. Additionally, our eQMS solution allows CDMOs to manage CAPA, deviations, non-conformance, documents, training, product life cycles, risk, audits, and more in a single centralized location. Our inspection management solution takes this further by providing an integrated approach that not only facilitates inspections, but also helps companies prepare for inspections with audit trails capturing every step of the process. By combining these two solutions together, CDMOs are able to streamline compliance efforts for better productivity without compromising on quality assurance efforts over time. This combination improves efficiency while increasing transparency throughout all stages of drug development and manufacturing – essential components in meeting regulatory standards today.

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OUR SOFTWARE

Find the Right ACE® Solution for Your Needs

PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software with particular specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries.

ACE Enterprise®

ACE® (Adaptive Compliance Engine®) Enterprise is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE® Enterprise, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant.

ACE Essentials®

ACE® (Adaptive Compliance Engine®) Essentials is an eQMS solution created for all highly regulated industries. ACE Essentials® comes equipped with a variety of Pre-Configured workflows and SOPs so you have a fully compliant, ready-to-go quality management system from day one. ACE Essentials® includes document management, training management, deviation investigation and CAPA management, analytical reporting, and much more.

ACE Inspection®

ACE Inspection® is a comprehensive solution designed to help you streamline regulatory inspection processes. ACE Inspection® allows your team to track all inspection requests and log notes in one centralized platform. Real-time updates and notifications help your team stay on top of inspection requests and respond in an efficient and timely manner. Whether you are dealing with FDA inspections, ISO audits, or other regulatory requirements, ACE Inspection® ensures that your team is always prepared and ready to respond.