Promoting a Validation Mindset: System Owners

The system owner is the individual responsible for the availability, security, compliance, maintenance, and support of a computerised system and for the security of the data residing on that system.  The system owner is initially responsible for oversight of the computer system validation effort, and is ultimately responsible for maintaining the system in a validated state throughout the life of the system.more

Promoting a Validation Mindset: Subject Matter Experts

Subject matter experts (SMEs) are considered to be those individual stakeholders in a computer system who contribute their technical expertise to the system validation effort.  Among the SMEs are system software developers, infrastructure support providers, process engineers, process owners and others who share in the responsibility for design and configuration of the system.more

Promoting a Validation Mindset: Overview

Among our cadre of validation engineers and specialists we offer an experienced and knowledgeable team of personnel whose area of expertise is focused on the delivery of validation services for computerized systems. With decades of combined experience in the computerized systems validation field, our team has gained an informed point of view of what constitutes a successful validation project and the organizational practices the make it successful.… more

Data Integrity Warning Letter Summary – August 2018

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Japanese bio-chemical manufacturing company.  The Warning Letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).  The letter cited non-compliance with section 501(a)(2)(B) of the 21 U.S.C.more

Legacy ERP Validation Project Summary

The Challenge

A mid-sized medical device company, subject to cGMPs, needed to bring their legacy Enterprise Resource Planning (ERP) system into FDA compliance. The system is called Sage 100. They had not validated it in the past. This was clearly a concern to them and a gap they needed to mitigate as soon as possible.… more

Data Integrity Assessment Project Summary

The Challenge

The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity issues among FDA regulated industries.  As a result, companies in the affected industries have begun instituting or updating their data integrity policies and best practices. … more

Microsoft R Validation Project Summary

The Challenge

A medical device manufacturing client contracted Performance Validation (PV) to assist with creating a Computer System Validation (CSV) package for Microsoft R. Finding evidence of other organizations validating R for GXP compliance did not prove fruitful.  Microsoft R is a free, open source application which uses the S language in statistical methodology.… more

Managing Data Integrity Risks for SCADA Systems

SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records.  As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data.  more

Critical Airflow Visualization Data Integrity

Aseptic manufacturing facilities have many critical qualification activities that rely heavily on high-quality data collection. One such activity is critical airflow visualization – commonly referred to as a smoke study. Smoke studies are used to demonstrate “laminarity and sweeping action over and away from the product under dynamic conditions” (FDA draft guidance “Sterile Drug Products Produced by Aseptic Processing”).more

Software as a Medical Device (SaMD): Clinical Evaluation and Validation

Your doctor is probably not using the data from your wearable (e.g. fitbit) to make decisions about your health. However, this is the kind of question we begin to ask when considering Software as a Medical Device (SaMD). By definition, these are applications (software) intended for medical use without the use of hardware (International Medical Device Regulators Forum (IMDRF) guidance).more