Computer Software Assurance – Risk Assessment Takes Center Stage

Regulatory compliance activities, such as Computer System Validation (CSV), can often be burdensome and challenging if they are approached without risk assessment. Often CSV deliverable completion is driven by procedures that are not designed to account for risk in relation to system, requirement, and processes.… more


Sage X3 FDA Compliance Validation

The Challenge

A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing.  They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. … more


CGMP Consultants Recommended in FDA Warning Letters

In a review of the latest one hundred (100) FDA Warning Letters issued as of May 17, 2019, nineteen (19) included the section header “CGMP Consultants Recommended” within the content of the letter, followed by these statements:

 “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging consultants qualified as set forth in 21 CFR 211.34more


PV @ Midwest Society of Quality Assurance Annual Meeting – 6-7 August 2019

PV’s  Kevin Marcial will be presenting “A Practical Guide to Risk Based Computer System Validation” at the Midwest Society of Quality Assurance Annual Meeting August 6-7, 2019. Come to Indianapolis to learn about risk-based CSV and other great topics in the QA world.… more


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?”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