Source: http://codingbliss.com/category/regulatory/
Timestamp: 2017-04-23 10:03:51
Document Index: 109434408

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art-11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Regulatory : Coding Bliss
January 26, 2012 by Lucas · Leave a CommentFiled under: Compliance, Healthcare, Regulatory Standard Operating Procedures (SOPs) – An SOP is a written document or instruction detailing all steps and activities of a process or procedure. ISO 9001 essentially requires the documentation of all procedures used in any manufacturing process that could affect the quality of the product.[1]
Step 2: The second document needed is an organization chart which outlines the roles and hierarchy of a company. This is important as this is the foundation of who is in authority and what they do, and this also dictates what they are required to be trained on. Download Word 2010 Org Chart Template Here: Example Org Chart Org Chart
Tags: CFR 21, Compliance, Regulatory Title 21 CFR Part 11: Test Protocols
January 25, 2012 by Lucas · Leave a CommentFiled under: Compliance, Healthcare, Regulatory I mentioned in an earlier post about protocols, in this post I will describe in detail what this looks like and how it is modeled to be successful.
3 – Defect Tracking 4 – Test Cases
Appendix Usually contains templates or worksheets and review sheets as documented evidence of the testing.
Tags: CFR 21, Compliance, Healthcare, Regulatory Title 21 CFR Part 11: Documentation
January 24, 2012 by Lucas · Leave a CommentFiled under: Compliance, Healthcare, Regulatory As part of the CFR validation process, what documentation is needed and how does this align with the law?
The overall validation process must be linked to your Standard Operating Procedures (SOPs) which are legally binding laws within an organization. There is a general pattern common to validation systems that are expected in the Part 11 industry, these are protocols and reports. Protocols: a protocol is a process that you follow, spelled out in great detail and the idea of it is you have a protocol that describes what you want to do.
Report: a report is a write-up about the execution of a protocol and the results of the protocol, protocols and reports go together A protocol and a report don’t really mean anything in the big picture unless you have SOP’s that dictate the use of protocols and reports and tie the whole process and system together in a type of “legal framework”
A Great example is software validation, how would this work with validation of a software system? You have a validation protocol, and a validation report, the protocol describes how you validate something, and the report is the write up on how the protocol execution went, So lets say you are testing module A in your new clinical portal, you draft up a validation protocol to test the system outlining everything you need to test, this usually includes screen-shots and signatures to ensure accountability and more evidence and a worksheet used to sign / initial each test is executed and passed or failed. Once complete, you then write up a report which outlines how it went, pass/fail and next steps, if things didn’t go well you can write a new protocol version or create a new protocol against the fixes needed. It is important to note that these documents need a process and the process needs to be complete (secure, auditable, etc..) using defect tracking, etc.. to ensure no defects are allowed in the system.
Tags: CFR 21, Compliance, Healthcare, Regulatory Title 21 CFR Part 11: FDA Guidance
January 23, 2012 by Lucas · Leave a CommentFiled under: Business, Compliance, Healthcare, Regulatory FDA Guidance Documentation:
There was a good point brought up in a comment from a reader of this blog around the fact that the FDA had withdrawn guidance documents around Part 11 therefore they do not enforce it. There is new guidance so it can be deceiving. You can see the withdrawn list here I am not linking to them since they are withdrawn the less that is known about them the better.: Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures Validation
Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps
Guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Compliance Policy Guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures
There is new guidance which can be downloaded here : [PDF version] or read here: http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
As you can see part-11 is still in effect, as this would impact public safety and any efficacy of data used in clinical trials among other things. Tags: CFR 21, Compliance, Healthcare, Regulatory Title 21 CFR Part 11: Predicate Rules
January 22, 2012 by Lucas · Leave a CommentFiled under: Business, Compliance, Healthcare, Regulatory Predicate Rules:
Well in any regulated industry there are the CFR’s (federal regulations) which spell out in detail the specifics, and other acts as well (Food, Drug and Cosmetic Act, or the Public Health Service Act and any ammendments) in our case of 21 CFR Part 11, we look at the GXPs (Good Clinical Practices, Good Manufacturing Practices) Tags: CFR 21, Compliance, Healthcare, Regulatory Title 21 CFR Part 11: E-Signature Compliance
January 18, 2012 by Lucas · Leave a CommentFiled under: Business, Compliance, Healthcare, Regulatory E-Signature implementation details:
Subpart C–Electronic Signatures Sec. 11.100 General requirements. (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
Sec. 11.200 Electronic signature components and controls. (a) Electronic signatures that are not based upon biometrics shall:
9 – Signature and Data must be stored together and not be separable. Tags: CFR 21, Compliance, E-Signatures, Healthcare, Part 11, Regulatory Title 21 CFR Part 11: Security Compliance
January 17, 2012 by Lucas · Leave a CommentFiled under: Business, Compliance, Healthcare, Regulatory Security implementation details:
Sec. 11.300 Controls for identification codes/passwords. Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:
Tags: CFR 21, Compliance, Healthcare, Part 11, Regulatory Title 21 CFR Part 11: Auditing
January 16, 2012 by Lucas · Leave a CommentFiled under: Business, Compliance, Healthcare, Regulatory Auditing implementation details:
Tags: Auditing, Business, CFR 21, Compliance, Part 11, Regulatory Title 21 CFR Part 11: Compliance
January 15, 2012 by Lucas · Leave a CommentFiled under: Business, Compliance, Healthcare, Regulatory The 3 areas (pillars) of compliance
3. E-Signatures (optional):If your software is converting paper to electronic and electronic is the primary store, then you must create an e-signature system that has security, auditing and is also a statement of intent within the system to ensure the signature is valid. Validation is another big piece you need a process that maps features to specifications to tests and this all is robust and transparent. Any function of software must be validated, with empirical evidence and physical artifacts, all best practice with clear and concise process.
Tags: Compliance, Part 11, Regulatory, Title 21 CFR Title 21 CFR Part 11: What is it and why is it important?
January 13, 2012 by Lucas · 2 CommentsFiled under: Business, Healthcare, Regulatory What is it?
Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
1 – it is just a law and has some ambiguity at that, you can see the law here: Law :and information here: Title 21 CFR Part 11, it is very small barley fits on 2 pieces of paper and has enormous consequences for software used in the regulated area of Clinical Trials. 2 – Whenever you have a legal area there is what the law says and second is the interpretation of the law, or more specially the interpretation and enforcement of the law. You have cases that have been taken to court and interestingly enough have had impact on how things are enforced and what you need to do to come under compliance. One such court case : here, essentially explains that you cannot grand-father electronic systems into compliance because of the risks and downstream effect, so this court case says that any systems that fall into compliance need to meet the new laws circa 1998.
If you wanted to innovate and differentiate yourself in this industry there is a big barrier to entry and interestingly enough regulatory compliance is expensive and also risky business so it creates a value moat if you can understand and use regulatory compliance to your advantage. If you can pass a Part 11 Audit it has extreme value to show not only that your software does what it says it does, it does what the law requires, which ensures safety, security and proper function. The most important part of this regulation is that you need to be certain that data in a clinical trial are true and exact, this impacts whether people live or die. Because of high risk and importance of the software systems once you get a system compliant it reaps enormous benefits in that you charge more money for the software, training, and validation of the system setups.
Tags: CFR 21, Compliance, Healthcare, Part 11, Regulatory Tags