Verification vs validation is a key understanding for regulatory professionals

For regulatory professionals, aspects of verification and validation, such as how to get verification and validation right, and an understanding of the ways in which verification and validation diverge from each other and converge, make up very important learning. The key point is that verification and validation should be risk based and be built keeping in mind the extant regulatory expectations.

Building a verification and validation process that sufficiently uses targeted and documented risk based verification and validation test case elements or scripts is the foundation to this. All these have to be reviewed against ISO 14971 and ICH Q 9 hazard analysis and product risk management.

Getting their V & V right involves gaining and exercising proper knowledge of these areas on the part of professionals working in regulatory environments. This learning is what a two-day seminar by GlobalCompliancePanel, a very well-known provider of professional trainings for all the areas of regulatory compliance, will impart.

V & V against the regulatory process

The Director of this seminar, John E Lincoln, a senior Consultant for Medical device and Regulatory Affairs, will explain the rationale behind verification and validation and clear all the ambiguities relating to this activity.

He will help participants to understand the following:

o   Evaluating different field-tested, U.S. FDA-reviewed V&V protocols

o   Ways by which to employ equipment/process Requirements Specs/DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500. John E Lincoln will help participants how to do all these against a background of limited company resources

o   Reviewing a matrix that simplifies “as-product”, “in-product”, process and equipment and related matters

o   Software VT&V to ensure that key FDA requirements are not overlooked

To enroll for this course, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900645SEMINAR?verification-vs-validation-qms-Las-Vegas.

The Director will also offer hands-on understanding of Quality Management Systems and 21 CFR Part 11. This seminar will help participants:

o   Understand Verification and Validation, differences and how they work together;

o   Discuss recent regulatory expectations;

o   Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;

o   Determine key "milestones" and "tasks" in a project;

o   Locate and document key subject "inputs";

o   Compile "generic" Master and Individual Validation Plans;

o   Learn the key element of a Product V&V File/Protocol;

o   Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;

o   Get a grasp of basic Test Case construction;

o   Understand sample sizes and their justification;

o   Learn the key elements of Software V&V expected by the FDA and how to document;

o   Deal with hardware and software vendors, sales and marketing

o   Consider a field-tested software V&V documentation "model";

o   See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.

Diligence should go into Software Validation Process for 21 CFR Part 11

Key Takeaway:

Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.

The FDA's Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR govern respective regulated areas.

What is 21 CFR Part 11?

Codes contained in21 CFR Part 11 relate to electronic records and approval signatures, which are digital versions of paper documents and handwritten signatures. 21 CFR Part 11enables

• A paper record to be replaced by an electronic record
• Any handwritten signature to be replaced with an electronic signature
• The software of these systems to be validated, so that the authenticity of electronic signatures can be proven
• An organization to implement good business practices.

Why is software validation process for 21 CFR Part 11 necessary?

With the widespread proliferation, reach and prevalence of the use of computers; it is a given that people would like to use electronic records instead of paper records. CFRs became necessary as records graduated to the electronic format, because of which validation of these signatures for their authenticity also became necessary.

An intrinsic part of SOPs

The software validation process for 21 CFR Part 11 is enshrined in the regulated company'sStandard Operating Procedures (SOP's), which describe the way in which processes are to be performed. In the course of implementation of the software validation process for 21 CFR Part 11; any paper record, inclusive of signatures, is to be replaced with an electronic one, given that the computer system is validated and has appropriate features.

Primary areas software validation process for 21 CFR Part 11 compliance

21 CFR Part 11 compliance consists of three primary areas:

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