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Whether you need a full, dedicated team, remote work, or assistance on a specific project, the SME’s at PV will bring valuable insights and tailored strategies to help you along the way. With PV’s best in class reputation, we bring a customized approach with each project, bringing fresh perspectives to critical issues within the FDA-regulated industries and building commissioning.
Areas of Expertise
ASRS – Automated Storage and Retrieval Systems
Audits
Document Writing
FDA 483 Warning Letter Remediation
Project Management
SOP Consulting
Staff Augmentation
503B and 503A Pharmaceutical Manufacturer
Related Content
During an FDA inspection in June 2023, several violations related to computer system / software compliance and general quality system processes were identified. Here is a link to the letter: Warning Letter CMS #653455 The warning letter details a variety of violations that can be addressed through computer system validation (CSV), computer software assurance, equipment […]
Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]
At a glance: A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year. CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]
