Kaye Validator AVS ICAL Software Validation

The Challenges

A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return the units to service.  … more

IBM Clinical Development EDC Validation

The Challenge

A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials.  Their clinical sites would enter study data into the software and it would expedite their data review and processing.… more

Data Integrity Risks on 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

503B Data Integrity Concerns

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

Audit Trail Review for Data Integrity

In December 2018 the FDA finalized its guidance titled “Data Integrity and Compliance with cGMP, Guidance for Industry.”  Among the topics covered in the guidance was ‘audit trails’. The answers to these two questions “How often should audit trails be reviewed?” and “Who should review audit trails?” may represent a significant update to the FDA’s interpretation and enforcement of predicate rules regarding the use of audit trails.… more

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