Tiêu đề [Document Control Specialist] Role Challenge.pdf ✅

1 Role Challenge - Document Control Specialist Bengaluru, Full Time As a Document Control Specialist you will play a key role by working across Product, AI, Clinical Data, and Clinical Quality teams. You will work closely with external auditors and regulatory consultants to ensure the organization's regulatory compliance. Role challenge is a two-way stream for the company and the candidate to assess the right fit for the role. This challenge will aid in a complete understanding of your roles and responsibilities and shall prepare you for the real-time scenarios you will encounter during your full-time. Important Information ● Expected time: 4-6 hrs ● Submission Details: ○ You will submit your challenge in PDF format, and email it to [email protected] ○ Email Subject: Document Control Specialist Role Challenge Submission ○ File name format: First_Last_Role_Team.pdf eg. Siddhant Kumar for the role of Document control analyst in Regulatory Team should submit as - Siddhant_Kumar_Regulatory.pdf ○ Please follow the Subject format or your submission will not be evaluated ● Feel free to connect if you require any clarifications at: [email protected] ● There is a task given below and you need to complete it to submit the role challenge successfully. ● Note: You are encouraged to submit earlier if you have completed the challenge instead of waiting till the deadline Role Challenge About the organization Organizational structure: Seven teams are working to bring the product to the market: ● Product - Product development and deployment. ● Software engineering - Software development of core product (software as a medical device [SaMD]) and internal tools. ● Clinical data engineering - Data engineering activities for AI development and validation. ● Clinical quality assurance - Quality control and assurance of the data for AI development and validation.
2 ● AI team - R&D of AI technologies. ● Regulatory affairs team - Compliance adherence and maintenance. ● Clinical research team - Conduct and manage clinical studies and trials for regulatory clearance. Introduction to ISO 13485 and Quality Management System (QMS): ISO 13485 is an internationally recognized standard that outlines the requirements for a Quality Management System (QMS) specifically designed for the medical device industry. It provides a framework for organizations involved in the design, production, installation, and servicing of medical devices to consistently meet regulatory and customer requirements. The goal of ISO 13485 is to ensure the safety, quality, and effectiveness of medical devices throughout their lifecycle, from development to delivery. A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities to achieve quality objectives. It ensures that an organization consistently produces products or services that meet customer and regulatory requirements. In the context of ISO 13485, the QMS is tailored to the medical device sector, emphasizing risk management, process control, and regulatory compliance to ensure patient safety and product quality. By implementing ISO 13485, organizations can demonstrate their commitment to high-quality standards, regulatory compliance, and continuous improvement in the manufacturing and management of medical devices. Task 1: SOP Creation You have been tasked with drafting a Standard Operating Procedure (SOP) for the Document Control Process at Origin Medical Research Lab. This SOP must adhere to Good Documentation Practices and ISO 13485 standards and outline how documents will be created, approved, and managed throughout their lifecycle. ● Create an SOP for document control that ensures compliance with ISO 13485 and 21 CFR Part 820 (limited to 5 pages). Hints for SOP content: As part of the SOP creation process, the approval workflow must be clearly defined to ensure that any new or updated SOPs receive proper review and sign-off from relevant stakeholders before being implemented. Each step of the workflow should guarantee that the document complies with ISO 13485, ensuring proper controls are in place before final approval. ● Outline the approval workflow for the SOP you just created. Who are the key stakeholders involved, and what steps must be taken from draft to final approval and documentation into the document control system Sub Tasks:
3 1. Master Document List: After your SOP is approved, it needs to be added to the Master Document List. This list acts as a repository for all controlled documents within the company. You will need to update the list, ensuring that it contains key information such as document name, version, approval date, and the individuals responsible for each document. Task: Add the currently created SOP to the Master Document List with the following details. Note: The above format for the Master Document List is for your reference, and you can add additional details for optimization. 2. Training Assessment: Once the SOP is developed and approved, the next step is to train employees on the document control procedure. To measure their understanding, you need to create a Training Assessment Form. This form shall include questions that test knowledge of procedural compliance and/or practical questions to assess how well they can apply the SOP in real-world scenarios. Task: Create a Training Assessment Form with at least 3 questions to evaluate an employee’s understanding of the new document control SOP. Reference Material: ● ISO 13485 - Reference Link 1 and Reference Link 2 ● 21 CFR 820 - Reference Link 1 and Reference Link 2 ● Good Documentation Practices - Learn the Good Document Practices for Medical Devices ● SOP Creation - Reference Link 1 and Reference Link 2 Task 2: The organization is changing its name from 'Origin Health' to 'Origin Medical'. The font size will be adjusted from 11 to 12, and the font style will change from 'Arial' to 'Roboto'. As the owner of the Document Control Standard Operating Procedure (SOP), you are responsible for overseeing the update of all relevant documents to reflect these changes. Additionally, you must ensure that the revised documents are approved, re-training is conducted for trained personnel, and versions are updated in the Master Document List. 1. You are required to update the following in the Document Control SOP. ● Organization's name from "Origin Health" to "Origin Medical"
4 ● Font size from 11 to 12 ● Font style from 'Arial' to 'Roboto' Create a Change Request Form to initiate this process. Hint for the creation of a change request form: Be sure to include: ● A description of the change. ● The reason for the change. ● A list of impacted documents (e.g., SOPs, templates). ● The departments affected. ● The required approvals and workflow for submitting the change request. 2. Describe the Change Request Process you would follow after identifying the need to update the organization's name in the Document Control SOP. Outline the key steps involved, from submitting the change request to obtaining final approval, including the implementation of the CR. 3. Create the Change Request Log to include the change request you have just submitted. Example Template: Note: The above format for the Change Request Log is for your reference, and you can add additional details for optimization. 4. Update the Master Document List (created in Task 1) to reflect the current document revision of the Document Control SOP. Note: Please provide the updated Master Document List separately for this task. 5. Create a training assessment form to evaluate the team’s understanding of the updated Document Control SOP. Reference Material: ● Change Control: Reference Link Task 3: Training Two new employees, Person A for the Regulatory Team and Person B for the Strategy Team have recently joined Origin Medical Research Lab. According to the training SOP, employees must be trained on both (i) company-wide SOPs and (ii) team-specific/role-specific SOPs. The training matrix given below is a part of the training SOP. You are expected to assign mandatory training that all employees must complete, as well as job-specific SOP training for each employee based on their respective roles (Regulatory and Strategy). Refer to the following training matrix for your task: