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So you have a Fitbit or activity tracker? How is it going – is it helping motivate you to move more, perhaps monitoring your heart rate? That is great – but is your doctor using the data to make decisions about your health? Probably not. However, this is the kind of question we begin to […]
Read MoreSmoke Studies
A review of the Form 483’s issued to the 45-registered and inspected 503B Outsourcing Facilities identifies that over 40% (n = 19) of the inspected facilities received one or more observations concerning inadequate smoke studies. Common findings of the smoke studies included studies that were not performed under dynamic conditions, studies that do not adequately reflect […]
Read MoreCurrent Inspection Trends From FDA Warning Letters
A review of warning letters posted on September 10, 2013, to the FDA website was conducted. Four of thirteen warning letters were issued by CDRH with a subject of Quality System Regulation for Medical Devices/Adulterated. Twenty-seven violations were identified at these four manufacturers. A break-down of the identified violations follows: Citation […]
Read MoreRepeated Failures
What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective? In a recent warning letter, FDA identified four citations: While not numbered as an observation, the FDA also commented that the firm does not always follow their current SOPs. Finally – FDA made […]
Read MorePromoting 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 […]
Read MoreWhy is Project Information so Important: How does Project Information translate to project success?
– Bruce Beck Project information is the data and documentation generated by a number of sources including engineering, vendors, automation groups, contractors and operations as well as the C&Q team over the course of the project. Accurate, complete information in the form of data, documentation and drawings is fundamentally important to not only the project […]
Read MorePerformance Validation Announces Martin Long as President and Chief Executive Officer
INDIANAPOLIS, Dec. 7, 2021 /PRNewswire/ — Performance Validation, Inc., a leading national provider of commissioning, qualification, and validation services, today announced that Martin Long has been named as President and Chief Executive Officer effective Jan 1, 2022. Dr. Van Doel, Performance Validations outgoing president will retain his role as Board Chairman, and will retire from Performance Validation in February. Long has more […]
Read MorePerformance Validation Acquired the Welsh Commissioning Group, Inc
(Indianapolis, IN) Performance Validation, Inc. has acquired 100% of the interests of the Welsh Commissioning Group, Inc. (WCG) headquartered in Auburn, Washington. Structured as a 100 percent employee-owned private company, or an “S corporation employee stock ownership plan” (S ESOP), Performance Validation (PV) credits its success to its employee-owners who operate with a vested interest in […]
Read MorePart 11 Compliance Considerations for SCADA Systems
Supervisory Control and Data Acquisition (SCADA) systems are tremendous assets in the pharmaceutical, medical device, and other FDA regulated manufacturing industries, providing cost efficiencies and improving the consistency of product quality. They have also enabled the industries to move from hardcopy to electronic production records. Systems used for manufacturing pharmaceuticals, medical devices, and other regulated […]
Read MoreOut of Specification Results
What happens when a firm obtains out of specification results? 21 CFR 211.192 states: All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy […]
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