task_categories:text-generation task_categories:text2text-generation task_categories:question-answering size_categories:n<1K format:parquet modality:text library:datasets library:pandas library:mlcroissant library:polars library:distilabel region:us synthetic distilabel rlaif datacraft
---
size_categories: n<1K
task_categories:
- text-generation
- text2text-generation
- question-answering
dataset_info:
  features:
  - name: messages
    list:
    - name: content
      dtype: string
    - name: role
      dtype: string
  splits:
  - name: train
    num_bytes: 2124883
    num_examples: 100
  download_size: 679179
  dataset_size: 2124883
configs:
- config_name: default
  data_files:
  - split: train
    path: data/train-*
tags:
- synthetic
- distilabel
- rlaif
- datacraft
---

<p align="left">
  <a href="https://github.com/argilla-io/distilabel">
    <img src="https://raw.githubusercontent.com/argilla-io/distilabel/main/docs/assets/distilabel-badge-light.png" alt="Built with Distilabel" width="200" height="32"/>
  </a>
</p>

# Dataset Card for fda-cfr-11-advance-qa

This dataset has been created with [distilabel](https://distilabel.argilla.io/).



## Dataset Summary

This dataset contains a `pipeline.yaml` which can be used to reproduce the pipeline that generated it in distilabel using the `distilabel` CLI:

```console
distilabel pipeline run --config "https://huggingface.co/datasets/Arun63/fda-cfr-11-advance-qa/raw/main/pipeline.yaml"
```

or explore the configuration:

```console
distilabel pipeline info --config "https://huggingface.co/datasets/Arun63/fda-cfr-11-advance-qa/raw/main/pipeline.yaml"
```

## Dataset structure

The examples have the following structure per configuration:


<details><summary> Configuration: default </summary><hr>

```json
{
    "messages": [
        {
            "content": "You are an AI assistant specializing in providing in-depth information on FDA CFR Part 11 compliance. Your purpose is to assist users in understanding and adhering to the regulations and guidelines outlined in Part 11, including 21 CFR part 11, which focuses on the electronic records and electronic signatures. Offer detailed explanations, provide examples, and suggest best practices for implementation, including 21 CFR 11 validation, electronic signature management, and data integrity. Be prepared to address various aspects of CFR Part 11, such as risk assessments, audit trails, and system validation. User questions are direct and concise.",
            "role": "system"
        },
        {
            "content": "I\u0027m an auditor and have a requirement to review an existing system to ensure compliance with 21 CFR Part 11.  What are some steps I can take to prepare for your review of the system and the company\u0027s compliance with 21 CFR Part 11?\n\n1.  Prepare a checklist of the system features that must comply with 21 CFR Part 11.\n2.  Establish a plan to obtain documents and records that demonstrate compliance with 21 CFR Part 11.\n3.  Conduct a walkthrough of the system to ensure compliant e-records and e-signatures are present.\n4.  Perform a review of policies and procedures to ensure consistency with 21 CFR 11 guidelines.\n5.  Identify systems and network hardware and software configurations to identify potential compliance risks.\n6.  Document all observations and findings to generate a report of the review.\n\nTo conduct an effective review of the system and the company\u0027s compliance with 21 CFR Part 11, which steps should you prioritize first?\n\n## Step 1: Review the company\u0027s 21 CFR Part 11 compliance plan\nReview the company\u0027s existing 21 CFR Part 11 compliance plan and policy to understand their approach to compliance. This will help identify any gaps or areas of concern prior to the systems review.\n\n## Step 2: Gather documentation and records\nGather all relevant documentation and records related to the system, including user manuals, system documentation, and records of system testing and validation. This will provide context to the system\u0027s functionality and help identify compliance issues.\n\n## Step 3: Identify system components and functionality\nIdentify the system components and functionality that require 21 CFR Part 11 compliance. This includes e-records, e-signatures, audit trails, and security measures.\n\n## Step 4: Review system functionality and configuration\nReview the system\u0027s functionality and configuration to ensure compliance with 21 CFR Part 11 guidelines. This includes review of system access controls, data integrity, and testing procedures.\n\n## Step 5: Perform a risk assessment\nPerform a risk assessment to identify potential vulnerabilities in the system and its components. This will help identify areas of high risk that require additional review.\n\n## Step 6: Test system functionality\nTest system functionality to ensure compliance with 21 CFR Part 11 guidelines. This includes review of user interface, data validation, and system logging.\n\n## Step 7: Document findings and report\nDocument all observations and findings to generate a report of the review. This report should include recommendations for areas of non-compliance and steps to achieve compliance.\n\nThe final answer is: $\\boxed{1}$",
            "role": "user"
        },
        {
            "content": "To conduct an effective review of the system and the company\u0027s compliance with 21 CFR Part 11, the first step you should prioritize is reviewing the company\u0027s 21 CFR Part 11 compliance plan. This step will allow you to understand the company\u0027s approach to compliance, identify any gaps or areas of concern, and set the stage for a comprehensive review of the system.",
            "role": "assistant"
        },
        {
            "content": "When it comes to 21 CFR Part 11 compliance, what is the intent of the regulation and the key requirements within it? \n\n",
            "role": "user"
        },
        {
            "content": "The intent of 21 CFR Part 11 is to ensure the security, integrity, and reliability of electronic records and electronic signatures in the pharmaceutical, medical device, and biotechnology industries. The regulation outlines the requirements for the use of electronic records and electronic signatures in these industries, with the goal of ensuring that electronic data is accurate, trustworthy, and reliable.\n\nThe key requirements within 21 CFR Part 11 include:\n\n1.  **Electronic Records**: The regulation requires that electronic records are created, modified, transmitted, or deleted in a manner that ensures the integrity, authenticity, and legibility of the records. This includes requirements for data generation, storage, and retrieval.\n2.  **Electronic Signatures**: The regulation requires that electronic signatures be used to ensure the authenticity of the signer and the intent of the signature. This includes requirements for user authentication, password management, and audit trails.\n3.  **Audit Trails**: The regulation requires that systems maintain an audit trail of all operations performed on electronic records, including who accessed the record, what changes were made, and when.\n4.  **System Validation**: The regulation requires that systems used to create, modify, or maintain electronic records be validated to ensure they function as intended.\n5.  **Risk Assessment**: The regulation requires that companies perform a risk assessment to identify potential vulnerabilities in their systems and implements controls to mitigate those risks.\n6.  **Security**: The regulation requires that systems be protected from unauthorized access, tampering, or disruption.\n7.  **Data Integrity**: The regulation requires that electronic records be accurate, complete, and legible, and that data be protected from unauthorized alteration or destruction.\n8.  **Personnel Training**: The regulation requires that personnel be trained on system use, security, and validation procedures.\n9.  **System Maintenance**: The regulation requires that systems be regularly maintained and updated to ensure continued compliance.\n\nKey definitions in 21 CFR Part 11 include:\n\n*   **Electronic Record**: Any aggregation of information created, modified, generated, sent, received, stored, connected, or otherwise handled by or for an electronic system.\n*   **Electronic Signature**: An electronic sound, symbol, or process, attached to or logically associated with other information in an electronic form and executed or adopted by a person with the intent to sign.\n*   **Electronic Signature Process**: A process used to generate, attach, and verify digital, manual, or electronic signatures to electronic records.\n*   **Commerce**: Includes the production, installation, and testing of finished devices, labeling, packaging, repackaging, relabeling, reprocessing, storage, and distribution of finished devices.\n\nBy understanding these key requirements and definitions, organizations can ensure they are in compliance with 21 CFR Part 11 and maintain the integrity and reliability of their electronic records and electronic signatures.",
            "role": "assistant"
        },
        {
            "content": "What are the key elements in FDA documentation requirements for 21 CFR part 11 compliance? \n\n",
            "role": "user"
        },
        {
            "content": "The FDA documentation requirements for 21 CFR Part 11 compliance include the following key elements:\n\n1.  **System Validation Documentation**: Include documentation of the system development process, risk assessment, test scripts, results, and validation certificates.\n2.  **User Acceptance Testing (UAT) Documentation**: Document the UAT process, including test scripts, results, and acceptance criteria.\n3.  **System Maintenance Records**: Maintain records of system maintenance, updates, and patches, including dates, times, and details of changes made.\n4.  **Audit Trail Documentation**: Record all access, modifications, and deletions of electronic records, including user ID, date, and time.\n5.  **Validation Records**: Maintain records of system revalidations, including the scope, schedule, and results of revalidations.\n6.  **Risk Assessment and Control Measures**: Document any identified risks, mitigation strategies, and controls implemented.\n7.  **Security Policy**: Develop and maintain a security policy that outlines the company\u0027s approach to security, including access controls, authentication, and authorization.\n8.  **Authentication and Authorization Documentation**: Document procedures for user authentication and authorization, including password policies and roles.\n9.  **System Emergency Procedure**: Develop and maintain a procedure for handling system emergencies, including backup and restoration procedures.\n10.  **Change Control Procedure**: Implement a change control process to ensure that all changes to the system are properly documented, evaluated, and approved before implementation.\n11.  **System Training Records**: Maintain records of user training, including training schedules, materials, and completion certificates.\n12.  **System Backup and Recovery Procedure**: Implement a procedure for backing up and recovering critical data.\n13.  **System Disaster Recovery Plan**: Develop a plan for recovering the system in the event of a disaster.\n\nAdditionally, the documentation should be:\n\n1.  **Readable and Understandable**: Easy to read and comprehend by the reviewer.\n2.  **Accurate**: Reflect the actual system implementation and usage.\n3.  **Comprehensive**: Include all critical information.\n4.  **Well-organized**: Easy to locate and access relevant information.\n5.  **Up-to-date**: Reflect current system configuration and changes.\n\nThe FDA also recommends that companies maintain documentation in a manner that allows for easy review and access, including electronic storage and retention.",
            "role": "assistant"
        },
        {
            "content": "What are the key differences between 21 CFR Part 11 requirements and EVMP requirements? 21 CFR Part 11 and EVMP are two separate regulations.  21 CFR Part 11 is focused on electronic records and electronic signatures in the pharmaceutical and biotechnology industries, whereas the EVMP regulation is focused on the requirements for the maintenance of the master data for finished pharmaceuticals.  Here are the key differences between the two regulations.\n\n### Key differences between 21 CFR 11 and EVMP:\n\n1.  **Purpose**: 21 CFR Part 11 focuses on electronic records and digital signatures, while the EVMP focuses on master data for pharmaceutical products.\n2.  **Scope**: 21 CFR Part 11 applies to all organizations involved in regulated activities, including pharmaceutical, medical device, and biotechnology industries. The EVMP applies to pharmaceutical companies with authorized representatives in the EU.\n3.  **Requirements**: EVMP requires maintenance of a central repository of master data for all pharmaceuticals, whereas 21 CFR Part 11 focuses on the security, accuracy, and integrity of electronic records and signatures in regulated industries.\n4.  **Data Protection**: EVMP requires companies to maintain a centralized database of master data, while 21 CFR Part 11 requires data integrity and security throughout the entire data life cycle.\n5.  **Electronic Records**: Both regulations require electronic records, but EVMP requires the use of electronic signatures for approved person documentation, while 21 CFR Part 11 requires electronic signatures for all electronic records.\n6.  **Authorized Representatives**: EVMP requires authorized representatives to maintain a Qualified Person (QP) declaration for each batch, while 21 CFR Part 11 does not require authorized representatives.\n\nIn summary, while both regulations focus on maintaining the integrity of regulated information, the scope and requirements differ.",
            "role": "user"
        },
        {
            "content": "The key differences between 21 CFR Part 11 and EVMP requirements are:\n\n1.  **Purpose**: 21 CFR Part 11 focuses on electronic records and digital signatures, while EVMP focuses on master data for pharmaceutical products.\n2.  **Scope**: 21 CFR Part 11 applies to all organizations involved in regulated activities, including pharmaceutical, medical device, and biotechnology industries. The EVMP applies to pharmaceutical companies with authorized representatives in the EU.\n3.  **Requirements**: EVMP requires maintenance of a central repository of master data for all pharmaceuticals, whereas 21 CFR Part 11 focuses on the security, accuracy, and integrity of electronic records and signatures in regulated industries.\n4.  **Data Protection**: EVMP requires companies to maintain a centralized database of master data, while 21 CFR Part 11 requires data integrity and security throughout the entire data life cycle.\n5.  **Electronic Records**: Both regulations require electronic records, but EVMP requires the use of electronic signatures for approved person documentation, while 21 CFR Part 11 requires electronic signatures for all electronic records.\n6.  **Authorized Representatives**: EVMP requires authorized representatives to maintain a Qualified Person (QP) declaration for each batch, while 21 CFR Part 11 does not require authorized representatives.",
            "role": "assistant"
        }
    ]
}
```

This subset can be loaded as:

```python
from datasets import load_dataset

ds = load_dataset("Arun63/fda-cfr-11-advance-qa", "default")
```

Or simply as it follows, since there's only one configuration and is named `default`: 

```python
from datasets import load_dataset

ds = load_dataset("Arun63/fda-cfr-11-advance-qa")
```


</details>




