Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Many regulated companies are still using unvalidated computer systems. Computer system validation is required by the FDA as well as ISO 13485: 2003. Medical device companies must transition to the 2003 version of 13485 by July 15.
This presentation will review the FDA and ISO requirements for computer system validation and describe methods for meeting those requirements. Emphasis is placed on applications currently used in production and quality systems, such as document control, ERP, complaint, and QA systems, and manufacturing execution systems.
What Will Attendees Learn?
Who Will Benefit
- What I have to validate to meet FDA and ISO 13485 requirements
- Why validation makes good business sense
- The top 11 errors in computer system validation
- What procedures are required and where to get them
- What approaches you can use: prospective, concurrent, and retrospective
- How to validate new systems with a prospective validation process
- How to validate existing systems using a combination of concurrent and retrospective validation
- What are the minimum deliverables that I must create
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical , and Biologics fields. The employees who will benefit include:
- End-users responsible for applications that need to be validated
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- Quality system auditors
, Ph.D., is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. Tim is the author of Computer System Risk Management and Validation Life Cycle
which is scheduled for release in April 2006 by Paton Press. Tim has written a set of policy and procedure documents and templates for computer system validation that are available through ComplianceOnline.
Tim brings a rare combination of knowledge to computer system validation. He has in-depth knowledge of software engineering, computer system implementation, the regulatory requirements and guidance documents for software development and validation, and quality system requirements. In the late 80’s, as a quality manager with Tandem Computers, Tim was responsible of supporting 250 software development companies in improving the quality of their products. For the past twelve years, Tim has helped regulated companies establish compliant quality systems and validate computer systems. He also has help companies obtain the ability to validate systems by providing tools and training.
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Related Documents :
- Validation of Off-The-Shelf Computer Systems (RiskVal)
This procedure defines the requirements for the validation of off-the-shelf and configured computer systems. It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485.
- Requirements for Computer System Requirements, Validation Plans, Protocols and Reports (RiskVal)
This procedure provides detailed outlines of what needs to be included in the most important computer system validation deliverables, including requirements, validation plans, IQ, OQ and PQ protocols, protocol reports, and the validation final report.
- Change Control for Validated Systems (RiskVal)
Once a computer system is validated, it must be placed under change control. The FDA and ISO 13485 require that changes be approved in advance. The change and the system must be appropriately tested to ensure that the change is effective.
- Computer System Vendor Qualification and Management (RiskVal)
Vendor qualification is required by the FDA and ISO 13485. The vendor qualification of most companies is centered on first article inspection of parts. This procedure answers the question: How do I qualify software and hardware vendors.
- Computer System Vendor Audit Checklist (RiskVal)
Poorly developed software could have ten times as many bugs as well engineered software. As with other products, quality has to be built in. If the software is of poor quality, validation testing is not going to make it function properly.
- IT Policy (RiskVal)
Part 11 requires certain IT policies regarding electronic records and electronic signatures. This policy document includes the IT policies needed in most companies, including those needed to meet Part 11 requirements and to protect validated computer.
- Validation Plan Template for Single System Validations (RiskVal)
The validation plan for a system is the definitive document on what will be done for the validation of that system. It includes how the system risk level will affect what is done and how. It provides the logic and justification for the validation.
- Computer System Technical Requirements Template (RiskVal)
The technical requirements template provides extensive instructions and examples for creating technical requirements for a computer system.
- Computer System IQ Template (RiskVal)
This IQ template provides extensive instructions on how to create an installation qualification protocol for a computer system. It includes examples of items to verify for 15 different types of hardware and software.
- Computer System OQ Template (RiskVal)
This OQ template provides extensive examples and instructions on how to create an Operational Qualification for a computer system. The general format for the OQ protocol is also applicable for OQs.
- Computer System PQ Template (RiskVal)
This PQ template provides extensive examples and instructions on how to create a Performance Qualification protocol for the validation of a specific computer system.
- Validation Final Report Template (RiskVal)
This template provides extensive instructions and examples for creating a validation report for a specific computer system or piece of equipment.