Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management.
The Importance of First Impressions on Inspection Day
Did you know that the first impression significantly impacts the audit inspector? The Inspector uses first impressions to gauge the confidence and “state of control” of your company. Find out how to make a good impression by reading this blog. Also, learn about what to do when the Inspector visits unannounced.
Building an Inspection Team
Inspections of a pharmaceutical or medical device manufacturing company may have more than one Inspector. There is usually a team of company employees managing the requests of each Inspector. Who should be on your inspection team?
This blog outlines who should be on the team and what the team should be doing before inspection day.
Inspection Day: Who to Call
Although the Quality Assurance Department leads the inspection day, Subject Matter Experts (SMEs) will be asked questions by the FDA inspectors. How to choose which SME to use? Read this blog to find out.
Practice Audits
The internal inspection team should be running audits to practice for surprise inspector visits. Practicing audits provides your Quality Assurance Department with information on gaps in readiness. Plus, practicing audits improves your confidence and gives the inspector assurance that you are in a state of control. Read about internal audits and how to improve your company one department at a time in this blog.
Inspection Management Software
The Inspector will request a multitude of documents. How can you keep track of the requests? On inspection day, you need to monitor who is filling the request, whether Quality Assurance has approved the document, whether the Inspector has received the record, etc. Using a combination of chat, email, excel sheets, etc., is time-consuming. The longer you take to fulfill a request, the more chaotic and not in a state of control you seem. Using an all-in-one inspection management software such as AuditUtopia® or ACE® Inspection can speed up your request fulfillment. Learn more about inspection management software in this blog.
Fulfilling Requests on The Inspection Day
This blog covers paper requests, electronic requests, and interview requests. This series of articles was written in collaboration with a former FDA inspector. Don’t miss our top tips! Find out the best practices for fulfilling requests.
Wrapping Up the Inspection
How you handle the end of an inspection? An audit might last several days. You may have some bad news. Read our blog on how to meet challenges and address concerns.
PSC Biotech® and PSC Software® provide support for inspections and audits.
PSC Biotech® experts have extensive knowledge and experience with submitting Global Regulatory Documents. We provide all highly regulated industries with pre-market and post-market activities for global life science submissions. Our teams develop and implement regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents.
PSC Software® options for inspection management include AuditUtopia® and ACE® Inspection. Read our case studies on how AuditUtopia streamlined inspection management for global pharmaceutical companies.
How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®
With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest.
Auditing – Quality Systems and Records
The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. PSC Biotech® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team.
Past Projects
Full-Service Application Management and Technical Support
Application Management and Technical SupportPSC Biotech supports the client by providing a wide range of support services for their software platform. Area: San Francisco Bay Area Project Type: Application Management, Technical Support and Training Services About this...
Technical Writing for San Francisco Biotech Company
Technical Writing for SF Biotech ClientPSC Biotech provided Technical Writing services to the client for their Facilities and Engineering Operations. Area: San Francisco Bay Area Project Type: Technical Writing About this Project OBJECTIVE The goal of this project is...
Software Validation
Software System Validation PSC Biotech provided eight years of Computer System Validation (CSV) services to the client during development and commercialization. Area: Bay Area Project Type:Computer System Validation (CSV) About this Project OBJECTIVE The goal of this...
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