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The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity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
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
503B Electronic Record Data Integrity
For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not followed.… more