Lab and Facility Move Management from Transcat: Frequently Asked Questions

Computer System Validation (CSV) is fundamental to all FDA-regulated industries. Get answers to some of our most frequently asked questions, learn how CSV services support the accuracy and consistency of your operating systems and software, and get a closer look at the benefits and experience of working with Transcat.   

A: Validation is required when your computer system, equipment, process, or method is used in a GxP process, or when it is used to make decisions about the quality of your product. Systems that are used to generate information for submissions to regulatory bodies like the FDA also require validation. Computer system validation is required for systems used to store electronic records, according to FDA 21 CFR Part 11.10(a) and Annex 11 Paragraph 4. 

A: Validation adds value to your systems by confirming that the system can and will perform as expected. It also removes the risk of regulatory non-compliance, which can stop or delay production and result in unexpected costs and challenges. 

A: Guidelines for validation for pharmaceutical manufacturing are in FDA 21 CFR 211.

A: Quality System regulation is located in FDA 21 CFR 820.

A: Key regulatory standards include guidelines from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). Additionally, compliance with Good Manufacturing Practices (GMP) is required. 

A:  Among the equipment essential to the temperature mapping process are temperature data loggers or sensors, calibration equipment for ensuring accuracy, and if humidity control is a factor, specialized humidity sensors are required. Data loggers should be able to record data at set intervals and be durable enough to withstand the specific environmental conditions of your storage areas. 

A:  It’s essential to establish a baseline for storage conditions. Temperature mapping should be performed again after any significant changes to the storage area (like changes in HVAC systems, relocation, or after major repairs), and then periodically as part of ongoing validation processes. It’s common for Transcat’s Solutions team to re-map a customer’s environment every one to two years - or in accordance with regulatory requirements. 

A:  Among the most common challenges when temperature mapping in a large or complex storage area include ensuring sufficient sensor coverage, data management and analysis, and maintaining minimal disruption to operations. Transcat will work with your team to understand your processes and minimize disruption.  

A:  If significant variations are detected, the Transcat team will recommend adjustments to correct them, such as recalibrating your HVAC systems, altering the layout of stored product to improve airflow, or adjusting the placement of product away from hotspots or cold spots. Follow-up mapping may be required to ensure that conditions have stabilized.

Partnering with Transcat’s Computer Systems Validation team can simplify your move and minimize disruptions so you can get back to doing what you do best. Contact us today for a tailored solution for your unique needs.