“Mike was a great colleague who was always there to help and share his expertise. He is knowledgable, easy to work with, delivered a quality result on time and on budget for all our clients. His expertise in the IT regulatory compliance area was an asset to the organization we both worked at. ”
About
Willing to do remote technical writing.
Desktop audits removes the need for…
Services
Contributions
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What are some ways to improve the documentation and reporting of Quality Assurance audits or reviews?
The key point to remember during the audit step and the report writing step is that auditing is objective. There is no room for subjective thinking. The auditor is verifying that the auditee adheres to their standards and that their standards accurately document their processes, are followed, and meet corporate and regulatory requirements. I totally support the idea of sending a draft audit report.
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How do you manage changes and updates to the validated system?
It has been my experience that using validation or any derivative of the term should be used as a program. Testing is a element of the validation program. In the last sentence changes are verified or tested, they aren't validated. This approach applies to the entire article.
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How do you measure and improve the quality of software documentation?
An excellent tool for verifying compliance with software quality standards are quality assurance review (QAR) forms. The forms would include the software quality requirements, and for each requirement a yes/no field for compliance to requirements, and a comment field. The form would be signed and dated by the reviewer. A form for each documentation stage is an option. I would recommend placing all software requirements in a single form and use each of stage as a quality gate. The quality gate determines if the software developer can proceed to the next phase of the documentation life cycle.
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How do you cope with the changes or revisions in quality control standards and guidelines over time?
In this section there is a list of items to consider for updating. One of the items mentioned is records. Records capture point in time activities and should be considered historical documents. Records provide evidence that something was completed. Therefore, records should not be updated.
Activity
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After all the legit buzz at re:Invent...a good reality check for anyone thinking about lift and shift without some detailed…
After all the legit buzz at re:Invent...a good reality check for anyone thinking about lift and shift without some detailed…
Liked by Michael Wyrick
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Is your QMS getting the job done? Does your QMS still match your processes and being followed? Are your software/hardware suppliers meeting your…
Is your QMS getting the job done? Does your QMS still match your processes and being followed? Are your software/hardware suppliers meeting your…
Liked by Michael Wyrick
Experience
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Best Practices Consulting Services
Publications
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GAMP A Risk-Based Approach to Compliant GxP Computerized Systems, Version5
ISPE
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GAMP Good Practice Guide; IT Infrastructure Control and Compliance
ISPE
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Validating Pharmaceutical Systems; Good Computer Practices In Life Science Manufacturing
Sue Horwood Publishing
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GAMP Good Practice Guide; A Risk-Based Approach to Compliant Electronic Records and Signatures
ISPE
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GAMP Guide for the Validation of Automated Systems, Version 4
ISPE
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Future State of Computer Validation
Pharmaceutical Technology
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Computer Validation: Validation of SAP R/3 – A Conceptual Approach
Pharmaceutical Technology
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Introduction to 21 CFR Part 11 Compliance
BioPharm
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PDA Technical Report 32: Process Model for Auditing Suppliers of Computer Products
PDA Journal of Pharmaceutical Science and Technology (FDA was part of team)
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A Harmonized Glossary for Computer Validation
PDA Journal of Pharmaceutical Science and Technology
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A Case Study of a Pharmaceutical User Group Software Audit
Pharmaceutical Technology (sharing audit report)
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Validation Key Practices for Computer Systems Used in Regulated Operations
Pharmaceutical Technology
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Guidelines for Quality Assurance Auditors
Pharmaceutical Technology
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PDA Technical Report 18: Validation of Computer-Related Systems
PDA Journal of Pharmaceutical Science and Technology (baseline for GAMP)
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A Systematic Approach to Quality Assurance Auditing
Quality Progress
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Computer System Validation: Auditing Computer Systems for Quality
Pharmaceutical Technology
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Computer System Validation - Staying Current: Vendor-User Relationships
Pharmaceutical Technology
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Computer System Validation - Staying Current: Security in Computerized Systems
Pharmaceutical Technology
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Computer System Validation - Staying Current: Installation Qualification
Pharmaceutical Technology
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Computer System Validation - Staying Current: Change Control
Pharmaceutical Technology
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Computer System Validation - Staying Current: Software Development Testing Strategies
Pharmaceutical Technology
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Computer System Validation - Staying Current: Introduction
Pharmaceutical Technology
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Join now to viewMore activity by Michael
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Is your QMS getting the job done? Does your QMS still match your processes and being followed? Are your software/hardware suppliers meeting your…
Is your QMS getting the job done? Does your QMS still match your processes and being followed? Are your software/hardware suppliers meeting your…
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KTK Pharma Solutions, LLC
Quality Compliance Need help ensuring your root cause analysis for OOS batches pass muster with the Agency? Or why your Quality Program is getting repeat observations despite internal oversight? Give KTK a call and have one of our industry experts previously employed by the FDA and industry operations help you get your Quality program back in compliance!
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COBBLESTONE (previously CfPA - The Center for Professional Advancement)
Introduction to CAPA Management - A Critical Quality System Requirement Register now for this vital training: https://hubs.ly/Q02FV1m90 🔍 Recent FDA form 483s and warning letters emphasize the importance of robust CAPA (Corrective Action and Preventative Action) programs in Quality Systems. 📝 Our upcoming 60-min accredited training will cover: - Writing effective CAPAs from initiation to follow-up - Building & strengthening CAPA Management for proactive Quality Management Systems - Analyzing key case examples for continuous improvement 💡 Stay ahead of industry trends & join us in mastering CAPA Management to prevent product recalls, complaints, & further FDA actions. Attend LIVE to engage with expert Laura Jeannel and other attendees - ask questions & get answers! DATE: August 1, 2024 from 11 am EDT - 12 pm EDT Can't make it live? On-demand option is available #CAPA #qualitysystems #FDA #483s #FDAwarningletters #quality #cobblestone
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