Benefits of Computer System Validation (CSV-GAMP®5)

• Accuracy – when test outcomes are routinely checked against predetermined expected results, the accuracy of computer systems within the manufacturing process can be relied upon

• Security – CSV processes make clear when entries to the system have been altered
• Reliability – the process ensures that system outputs can be relied upon throughout the lifecycle
• Consistency – it also ensures that the system output is consistent across its lifecycle
• Optimization – following the process also means that computer systems can be more easily optimized. Optimization is a key feature of an effective and efficient manufacturing site.

Computer systems validation when properly applied can help eliminate unexpected costly expenditures and enhance the lifetime of the computer system.

For further assistance regarding how to validate your new or existing equipment computer software/systems or commissioning contact us.

Biotech and medical device companies are regulated by national and international regulatory bodies (FDA 21 CFR Part 11-820 & IS0-13485.75). There are strict guidelines that must be followed, especially when the goods produced by these companies are for human-use or clinical studies. Computer System Validation (CSV) is one of those compliance requirements and is part of the Quality Management System within pharmaceutical and medical device manufacturing. In addition, it is a good business practice to ensure that the equipment/systems used in the production or testing of product for human-use are compliant. That, it functions as expected and the safety of the user, environment, and security of the computer system (CSV) is not comprised. Many businesses invest so much money on equipment and computer systems, but they ignore key essentials to the quality and performance of their computer systems. Thus, leading to waste of resources and unforeseen delays in their product’s approval.

For further assistance regarding how to validate your new or existing equipment computer software/systems or commissioning contact us.

PIL&M Inc., announces its article or corporation filing

Placer Inspection Lab & Manufacturing announces its recent filing of article of corporation with the state of Wyoming, therefore it has changed its name to PIL&M Inc.

PIL&M Inc. is a privately owned minority business enterprise with over 25years of experience in engineering consulting services for biotech and medical device companies. It specializes in catheter designs and developments (Medical Devices), engineering consulting for computer system validation – CSV (GAMP5), engineering consultant for test automation system development using LabView/C++ programming language, engineering consultant for additive manufacturing, and engineering consultant laser cut and laser welding. It’s research lab and manufacturing facility is located in North Highlands, CA while serving many clients in the San Francisco, Bay area and beyond. For all inquiries about PIL&M Inc., visit Https://www.pilnm.com

Any computer-based equipment or fixture that is required for testing or the production of clinical or human use devices must be validated prior to use.  Computer System Validation (CSV) – GAMP5 (Good Automated Manufacturing Practice V-Model), is a guidance per FDA 21 CFR Part 11-820 & IS0-13485.75, that all Biotech and medical device companies usually follow to ensure that their respective testing or manufacturing equipment functions and performs as intended or expected. Through means of proper documentation and traceability each equipment is validated as follows:

Identify the Computer System

• Identify the equipment used in the manufacturing process. Either it is;
  • New Equipment or recently purchased
  • Used during a development of a new product or manufacturing

Determine the required validation

• The purpose of the computer system e.g.:
• Determine if computer system is new or previously validated
• Store quality records
• To demonstrate compliance to a regulation
• To track quality audit details
• Maintenance of training records
• Make quality decisions
• Maintenance of calibration records or tracking of calibration conditions

Validation Scope

Document the category of the equipment

• Category 1: Infrastructure Computer Software
• Category 2/3: Products which are used Off-The-Shelf (OTS) or without software
• Category 4: Computer software that are configured for a specific business operation
• Category 5: Custom computer software system developed to meet individual user requirements, where there is no commercial Computer software System available.  Note: if the answer to the above questions are NO, the computer software system does not have to be validated.
• Based on the selected computer system category, validation must be performed per the following deliverables – FAT, SAT, FS, URS, IQ, OQ, PQ, Risk Hazard Analysis

Validate System

• Capture all pertinent validation deliverables on a computer system validation form
• Identify the safety, compliance, environmental impact, ergonomics and business risks
• Execute all documented test cases per the computer system validation plan/protocol
• Document all the test cases result in the computer system validation report
• Document any deviations taken from the plan in the deviation section of the computer system validation report
• Update the software configuration section of the computer system validation report
• Release the computer system validation report including all pertinent documents that may have been created.

Maintain Validated System

• Validated computer systems must be retained in a revision-controlled data archive application
• Revalidate as required if there are any changes to the computer systems or software

For further assistance regarding how to validate your new or existing equipment computer software/systems or commissioning contact us