PSC Biotech Corporation Presentation for Bio Cost Savings

This video provides an in-depth exploration of PSC Biotech Corporation's software and service solutions tailored for life science companies, presented in the context of their partnership with the Biotechnology Innovation Organization (BIO). The presentation, led by Thomas, details the company's background, its specific software offerings, and its computer systems validation services, culminating in a discussion of the exclusive benefits available to BIO members. The core purpose is to showcase how PSC Biotech helps companies transition from paper-based or legacy quality management systems to modern, cloud-based, and compliant electronic solutions that provide actionable insights.

The presentation begins with a brief history of PSC Biotech, founded in 1996, highlighting its growth to over 1,000 clients worldwide and the addition of specialized divisions, with a particular focus on PSC Software, established in 2009. The impetus for PSC Software was the observed dissatisfaction among companies with existing quality management processes, driving the need for user-friendly, cloud-based software capable of delivering actionable information. This led to the development of three primary software solutions: ACE, ACE Essentials, and AuditUtopia, each designed to address specific needs within the life sciences quality and compliance landscape.

The video then delves into each software solution. ACE (Adaptive Compliance Engine) is presented as a single-platform enterprise quality management system, designed to minimize administrative burdens and maximize ROI through productivity gains, all within a 21 CFR Part 11 compliant framework. It offers adaptability to various business processes, enabling real-time tracking and reporting for compliance, quality, and operational activities such as managing CAPAs, deviations, controlled documents, training, and supplier audits. Key differentiators include its unified platform approach, transparent pricing (no separate modules), high configurability, integrated analytics, and intuitive user interface, supported by numerous pre-configured workflows. ACE Essentials is introduced as a streamlined EQMS for startups and small life science companies, offering essential quality processes, pre-loaded SOPs, policies, and a quality manual for immediate compliance, with a simple upgrade path to the full ACE system as companies grow. Lastly, AuditUtopia is detailed as a standalone, real-time inspection management software, crucial for hosting regulatory inspections and client audits by enabling efficient tracking of scribe notes, requests, and related activities, ensuring teams stay organized and responsive.

Beyond software, PSC Biotech emphasizes its Computer Systems Validation (CSV) services, leveraging over two decades of consulting experience to provide FDA and EMA compliant, customized solutions. These services cover validation for a wide range of third-party enterprise systems, including ERP, DMS, VMS, and BMS, alongside specialized services for 21 CFR Part 11 compliance, data integrity assessments, remediation, and training. The presentation concludes by outlining the significant discounts and free trial offers extended to BIO and state affiliate members across PSC's software and CSV services, reinforcing their commitment to supporting the life sciences community with compliant and efficient solutions.

Key Takeaways:

• Addressing Legacy System Challenges: PSC Biotech was founded on the premise of solving common industry pain points related to inefficient paper-based or outdated legacy quality management systems, offering modern cloud-based alternatives.
• Comprehensive Enterprise Quality Management (ACE): The Adaptive Compliance Engine (ACE) serves as a unified, single-platform EQMS that manages a broad spectrum of quality and compliance activities, including CAPAs, deviations, controlled documents, training, and supplier audits, all within a 21 CFR Part 11 compliant environment.
• 21 CFR Part 11 Compliance Focus: A central theme across all PSC Biotech's software and services is adherence to 21 CFR Part 11, ensuring electronic records and signatures are trustworthy and equivalent to paper records, which is critical for regulated life science companies.
• Integrated Analytics for Actionable Insights: ACE incorporates an integrated analytics and visualization platform, enabling users to extract actionable information from their quality data, supporting data-driven decision-making and continuous improvement.
• Tailored Solutions for Small Businesses (ACE Essentials): ACE Essentials provides a pre-configured and pre-validated EQMS specifically designed for life science startups and small companies, offering a rapid, compliant solution with pre-written SOPs, policies, and a quality manual to expedite compliance from day one.
• Seamless Scalability: For small companies starting with ACE Essentials, there is a clear and simple upgrade path to the full ACE system, ensuring the solution can grow with the company's evolving needs without disruption.
• Specialized Inspection Management (AuditUtopia): AuditUtopia offers a dedicated, real-time inspection management software that streamlines the process of hosting regulatory inspections and client audits, enhancing organizational readiness and responsiveness through real-time updates and configurable dashboards.
• Extensive Computer Systems Validation (CSV) Services: PSC Biotech provides expert CSV services, ensuring FDA and EMA compliance for various third-party enterprise systems (ERP, DMS, VMS, BMS), which is crucial for maintaining data integrity and regulatory adherence across a company's technology stack.
• Data Integrity and Remediation Expertise: Beyond validation, their CSV services include data integrity assessments, remediation, and training, highlighting a holistic approach to ensuring the reliability and accuracy of electronic data in regulated environments.
• Flexible and Configurable Software: ACE is designed to be highly adaptive and user-configurable, allowing the software to conform to a company's specific business processes rather than forcing the company to adapt to the software.
• Transparent Pricing Model: PSC Software employs a transparent pricing model for ACE, where all pre-configured workflows are included, and there are no separate modules to purchase, simplifying budgeting and maximizing perceived value.
• Strategic Industry Partnerships: The partnership with BIO, offering significant discounts on software and services, demonstrates PSC Biotech's commitment to supporting the broader biotechnology ecosystem and making compliant solutions more accessible to its members.

Tools/Resources Mentioned:

• ACE (Adaptive Compliance Engine): Enterprise electronic quality management system.
• ACE Essentials: Electronic quality management system for small life science companies and startups.
• AuditUtopia: Stand-alone real-time inspection management software.
• BIO (Biotechnology Innovation Organization): Industry organization partnered with PSC Biotech.

Key Concepts:

• Electronic Quality Management System (EQMS): Software solutions designed to manage and automate quality processes and documentation in a regulated environment.
• Computer Systems Validation (CSV): The process of ensuring that computer systems used in regulated industries perform as intended and meet regulatory requirements (e.g., FDA, EMA).
• 21 CFR Part 11: Regulations issued by the FDA governing electronic records and electronic signatures, ensuring their trustworthiness, reliability, and equivalence to paper records.
• CAPA (Corrective and Preventive Actions): A system for identifying, documenting, and addressing non-conformances and preventing their recurrence.
• Deviations: Departures from approved instructions or established standards.
• Change Control: A formal process used to manage modifications to documents, procedures, or systems in a regulated environment.
• Controlled Documents: Documents (e.g., SOPs, policies, specifications) that are managed under a formal control system to ensure accuracy, approval, and distribution.
• Learning Management System (LMS): A software application for the administration, documentation, tracking, reporting, automation, and delivery of educational courses or training programs.
• Data Integrity: The assurance that data is accurate, consistent, and reliable throughout its lifecycle, critical for regulatory compliance.