Digital transformation is more than a buzzword; it is a comprehensive journey that reshapes how organizations operate, innovate, and deliver value. In FDA-regulated industries such as pharma manufacturing and medical device production, digital transformation is not just about integrating new technologies but about rethinking processes, culture, and leadership to drive sustainable growth. Robert Perks, a […]
Performance Validation, Inc. (PV) is thrilled to announce that Robert Perks has joined our team as the new Digital Solutions Director. This strategic addition to our team will significantly enhance our Automation and CSV services, including IT and OT CSV, Process Automation, Paperless Validation, and Digital Transformation initiatives. Robert’s extensive experience and expertise will undoubtedly […]
Laboratory Information Management Systems (LIMS) are pivotal in managing data, improving efficiency, and ensuring compliance in pharmaceutical and medical device manufacturing. However, the process of LIMS validation can be daunting, given its technical and regulatory complexities. This step-by-step guide aims to demystify the process and provide clear guidance for manufacturers. Step 1: Understanding Regulatory Requirements […]
Choosing the right Laboratory Information Management System (LIMS) vendor is a critical decision for any pharmaceutical or medical device manufacturing company. The right vendor not only ensures compliance with stringent regulatory standards but also enhances the efficiency and effectiveness of your laboratory operations. Here are six must-have qualities to look for in a LIMS vendor. […]
In the pharmaceutical industry, computerized systems (hardware, software, processes) play a critical role in creating and managing data, producing products, and ensuring compliance with regulatory requirements. 21 CFR Parts 210 and 211 contain aspects which drive the need for computer system validation (CSV). Of course, there is 21 CFR Part 11 (electronic records and signatures) […]
Computerized systems (hardware, software, and processes) play a critical role in the medical device industry. They are used to create and manage data, produce products, and ensure compliance with regulatory requirements. Computer system validation (CSV) is the process of ensuring that computerized systems meet their intended requirements and can consistently produce accurate and reliable results. […]
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 […]
In Food and Drug Administration (FDA) regulated industries, computer systems and software play a critical role in managing data, controlling processes, and ensuring compliance with regulatory requirements. To ensure the safety, efficiency, and quality of pharmaceutical products, the FDA has established specific regulations and guidance documents that outline the requirements for computer system validation (CSV) […]
Enterprise Resource Planning (ERP) validation is a critical step for FDA-regulated industries, to ensure compliance with regulatory requirements and industry standards. This process ensures that the ERP system accurately and consistently tracks and records critical data, such as product information and manufacturing processes. In this blog post, we will discuss why it is necessary to […]
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.
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