Catalyst delivers PSCI audits as part of a broader EHSS portfolio backed by 20+ years of experience in the pharmaceutical, medical device, and biotechnology industries. Its internal team has completed hundreds of audits across the US, EU, LATAM, and APAC, ensuring assessments go beyond checklists and focus on real supply-chain and enterprise risk.
We conduct these audits through a disciplined, end‑to‑end process that is designed to be globally scalable, technically robust, and closely aligned with PSCI guidance and pharmaceutical industry expectations.
In this blog, we outline the 6 steps that the Catalyst takes to ensure that PSCI audits are delivered in a way that exceeds industry standards.
1. Client engagement and audit planning
Catalyst begins by working with the client to clarify the purpose of the PSCI audits, define scope (suppliers, sites, and topics), and align with PSCI protocols and client-specific risk frameworks. For large programs, Catalyst develops a coordinated global audit plan and schedule to meet timelines, drawing on experience delivering dozens of PSCI-based supplier audits across multiple countries.
2. Assembling and vetting the audit team
Auditors are selected from Catalyst’s internal staff and vetted external partners, based on prior PSCI auditing experience, EHS and labor/ethics audit background, pharmaceutical industry knowledge, and language skills. The Principal Consultant for Global Audits reviews auditor CVs against PSCI minimum qualification requirements, and auditor profiles are shared with clients for acceptance before audits commence.
3. Auditor training and calibration
Before fieldwork, auditors receive internal training on PSCI audit objectives, logistics, document preparation, and reporting expectations, including the use of supplier self-assessment questionnaires and PSCI guidance. For multi-site projects, Catalyst conducts webcast trainings to calibrate auditors on PSCI protocols, client-specific risk criteria, and pharmaceutical focus areas such as pharmaceuticals in the environment and antimicrobial resistance.
4. Site-level preparation and coordination
Catalyst coordinates with each supplier to confirm audit dates, share document request lists, and align on confidentiality and non-disclosure arrangements between the client, supplier, and audit team. Suppliers are briefed on the PSCI audit purpose, pre-audit documentation expectations, and practical arrangements for on-site activities such as interviews, tours, and access to HR and EHS records.
5. Execution of PSCI-based audits
During the audit, Catalyst follows the PSCI audit process: opening meeting, facility tour, worker and management interviews, document review, and a closing meeting that previews findings and next steps. Auditors assess supplier performance across ethics, human rights and labor, health and safety, environment, and management systems, using PSCI tools and templates while ensuring factual, evidence-based observations rather than opinion.
6. Reporting, quality assurance, and follow-up
All PSCI audit reports are drafted by the site auditors and then undergo centralized quality review by the Global Auditing Lead, who checks language, technical accuracy, risk calibration, and alignment with PSCI finding classifications. Draft reports are shared with clients for comment, feedback is relayed to auditors, and Catalyst tracks auditor performance over time, using client feedback and report quality to continually improve its PSCI audit delivery.
Catalyst’s PSCI audit methodology reflects more than a process—it reflects a global capability built on depth, discipline, and decades of pharmaceutical supply chain experience. By combining a rigorously trained auditor network with a centralized quality-assurance engine, Catalyst delivers audits that go far beyond compliance checklists to uncover the risks, behaviors, and system gaps that truly shape supplier performance.
Our ability to operate seamlessly across regions, cultures, and supplier types—while maintaining strict alignment with PSCI protocols—positions Catalyst as a trusted partner for companies seeking transparent, consistent, and actionable insights across their value chain. As pharmaceutical supply chains grow more complex and regulatory expectations rise, Catalyst stands ready to help clients strengthen governance, elevate supplier standards, and build a more resilient, ethical, and sustainable global supply ecosystem.
