Software Catalysts has become a recognized leader in providing a variety of compliance services to the Life Sciences/Pharmaceutical/Biotech Industry. As a full-service company we have been helping life science companies become compliant with IT-related regulations and guidelines. We help our clients improve the level of compliance while reducing their compliance costs.
Our knowledge of current regulatory expectations and international standards, combined with our technology expertise, enable us to understand the challenges and issues faced by pharmaceutical, biotech and medical device companies. We help our clients achieve their business goals and objectives while maintaining regulatory compliance and a state of control across all operational areas within the enterprise.
With a depth of expertise in all facets of the system life cycle we are able to assist our clients to reach their goal of Optimal Performance. This includes Research & Development, Clinical Trials, Quality Assurance, Laboratory, IT/IM, Operations, Manufacturing and Distribution. We will evaluate and access your current business operations then provide solutions to streamline processes and reduce regulatory exposure. The application and implementation of recommended standard solutions will increase harmonization and management of critical cross-functional business systems. All this helps in mitigating the risk of non-compliance, reducing costs, increasing profitability, and helping to achieve Operational Excellence.
Software Catalysts has been working with regulated industries for many years now, giving us a unique perspective and an understanding of what it takes for any size company to be in compliance with FDA and other governmental regulatory agencies. We have demonstrated expertise in the following areas:
- Computer Systems Validation - CSV
- 21 CFR 11 - Electronic Records / Signatures
- Validation of applications (requirements, traceability, protocols, scripts, summary reports)
- Localized regulatory compliance assessments and remediation
- Infrastructure qualification
- CSV project management
- Coaching CSV projects as compliance experts
- Training on CSV, Part 11, Auditing, and Testing
- Retrospective evaluation/validation of legacy systems
- System testing
- Supplier audits
- SOP development.
- Clinical Adverse Event Systems / Data Mgmt. and Safety / CAPA Systems
- Manufacturing Equipment Qualification and Process Systems (C&Q)