Electronic Records; Electronic Signatures

undefined. Electronic Records; Electronic Signatures.

undefined. Benefits of Part 11 Training and Implementation.

undefined. FDA 21 CFR Part 11 Training Objectives.

undefined. Each employee shall be trained regarding her/his responsibility for the correctness of electronic records and signatures and possible consequences in case of misconduct! IT implements FDA 21 CFR Part 11 requirements as part of IT applications, so IT employees shall be familiar with and adhere to this compliance topic when applicable..

undefined. Martha. FDA 21 CFR Part 11 Training Structure.

undefined. U.S. Food and Drug Administration (FDA) issued the final Title 21 of the Code of Federal Regulations, Part 11 - Electronic Records; Electronic Signatures FDA 21 CFR Part 11 defines the requirements under which the FDA considers electronic records and electronic signatures as trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. In other words, Part 11 is an FDA regulation that legally imposes requirements on manufacturers when they choose to maintain FDA required records in electronic form..

undefined. There are multiple FDA regulatory requirements / predicate rules that apply to medical device manufacturers. Medical Device Manufacturers which intend to sell medical devices in the United States of America shall establish and maintain a Quality Management System (QMS) for the Design, Manufacture, Packaging, Labeling, Storage, Installation, and Servicing of their finished medical devices according to 21 CFR Part 820. Each org unit shall define within their QMS controls to fulfill regulatory compliance. SHS IT, while not producing medical devices, does provide Healthineers with non-product software in support of the design, manufacturing, packaging, labeling, storage, installation and servicing of medical devices – where Part 11 requirements may be relevant. Quality Interface Agreement QIA4 has been established by QT to define the delivery of regulatory compliant IT services by IT (as a primary supplier of non-product software) for various BLs. The QMS for IT is embedded within ITSM – where processes are defined to safeguard the IT applications for Part 11 when applicable and fulfill the delivery described in QIA4..

undefined. Why is Part 11 Important?. Compliance to Part 11 is of the same importance as the other applicable FDA regulatory requirements or predicate rules. The FDA is enforcing fulfillment of these requirements by inspections. Noncompliance to Part 11 observed in an FDA Inspection can result in multiple consequences for Siemens Healthineers (e.g., an FDA Warning Letter)..

undefined. Note: The predicate rules tell us which records are quality relevant. 21 CFR Part 11 mandates additional requirements for specifically identified quality relevant records..

undefined. When is Part 11 not applicable?. The 21 CFR Part 11 requirements do not apply for: IT applications, which do not store regulated records for further use. However, those IT applications shall be validated as Q-relevant. Paper records sent and received by fax or transmitted by electronic means. Any regulatory activities required by predicate rules or by a manufacturer’s quality management system which is based on a paper system only even if these records are stored electronically..

undefined. QR 0 defines mandatory quality management system and process requirements..

undefined. The Siemens Healthineers units shall implement the following requirements in their QMS: Each Organizational Unit which is using electronic records and/or electronic signatures for quality related documentation shall document in its quality management system how the requirements of 21 CFR Part 11 are fulfilled, and compliance is maintained. ITSM processes and Compliance Companion Tool Each unit shall appoint a 21 CFR Part 11 officer, responsible for compliance and ensuring compliance for purchase or development of IT Systems for internal use. ITSM List of SHS IT Internal Contacts Each employee is in the same way as for paper records responsible for the correctness of electronic records and electronic signatures. IT PD 15 A01 – Documented Information Control Each employee shall be trained about his/her responsibility regarding the correctness of electronic records and electronic signatures. Training IT PD 15 A01 – Documented Information Control and this FDA 21 CFR Part 11 Training.

undefined. Administrators shall not: Create/change/modify/delete electronic records/audit trails/signatures/signature manifestations in the name of others; Inspect nor demand passwords or cryptographic keys or give anyone else access; and Influence the signature record linking (for electronic as well as for handwritten signatures). Administrators shall be trained regarding their special responsibilities. FDA 21 CFR Part 11 Training.

undefined. Examples of the in-scope electronic records for the design, manufacturing, packaging, labeling, storage, installation and servicing of medical devices include: Device History File (DHF), also called Engineering History Record (EHR): design and engineering records, e.g., specifications, tests results Device Master Record (DMR): requirements on which production is based, e.g., drawings Device History Record (DHR): records of history and maintenance of every single product, e.g., test results, serial numbers Quality System Record (QSR): e.g., Q-procedures, process descriptions, data of the CAPA-process.

undefined. A Siemens Healthineers medical device injures a patient directly or performs in a sub-standard way injuring a patient indirectly. IT did not manufacture the device or develop the software that is part of the medical device, however, any pending investigation can include records from IT services/applications which must be protected: How was the device manufactured? Were the suppliers of any device components managed appropriately? Were marketing materials for the device accurate to avoid misuse? Was the device installed correctly? Were installation personnel trained to do their jobs? Were there any complaints registered with respect to the device? Was the device serviced in an adequate manner? Were service personnel trained to do their jobs?.

undefined. [image]. [image]. Part 11 Subparts and Sections What Does Part 11 Require?.

undefined. How does IT Determine Part 11 Relevance? Completing the Q-Aspect of Compliance Companion Pre-Assessment.

undefined. IT Application Manager Creates Compliance Companion entry Updates CMDB Incorporates resulting requirements into application Updates quality documents as needed 1.

undefined. During the session it is important to review each page and each question carefully within the tool. Just-in-time references are included in the tool to support the topics if determining the answer requires deeper discussion: Subparts Definitions Examples Disclaimer.

undefined. Based on the answers to the questions, Part 11 Requirement Sets needed for the IT application will be provided by the tool. Possible sets are: Closed System Electronic Records (ELREC) Open System Electronic Records (ELREC) Electronic Signatures (ELSIG) Hybrid System Electronic Signatures (ELSIG) The tool Requirement Set(s): Help establish a core set of quality relevant and Part 11 requirements Include support on the Instructions tab Must be included in and managed as part of the application requirements Should be easily identifiable and retrievable in the event of audit As the application changes over time, it is important to evaluate each change and determine if the change impacts any of the Q-Aspect answers. If so, a Compliance Companion entry should be created for the release..

undefined. Healthineers Employees Ensure correctness of electronic records and electronic signatures as defined by QR0 Assure and maintain the validity of the referenced information.

undefined. Conclusion. This training has explained: WHY training is necessary for IT WHAT FDA 21 CFR Part 11 is HOW Part 11 applies to IT WHY Part 11 is important WHEN Part 11 is applicable WHEN Part 11 is not applicable WHAT is defined for Siemens Healthineers WHICH records are in scope of Part 11 WHAT Part 11 requires HOW to determine Part 11 relevance in IT WHO is responsible for Part 11 compliance.

undefined. Thank you for your attention!. 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Additional Information. References: FDA 21 CFR Part 11 Electronic Records; Electronic Signatures FDA 21 CFR Part 820 Quality System Regulation SHS QR 0 - 21 CFR Part 11 Electronic Records; Electronic Signatures SHS GD 80 - Interpretation of 21 CFR Part 11 SHS QIA 4 - Quality Interface Agreement - IT Services List of SHS IT Internal Contacts ITSM Service Management Portal SHS IT PD 15 A01 Documented Information Control FDA Guidance: FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

Back up Definitions (1 of 2). 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Back up Definitions (2 of 2). 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Back up Subpart A – General Provisions. 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Back up Subpart B – Electronic Records (1 of 3). 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Back up Subpart B – Electronic Records (2 of 3). 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Back up Subpart B – Electronic Records (3 of 3). 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

Back up Subpart C – Electronic Signatures (1 of 3).

Back up Subpart C – Electronic Signatures (2 of 3).

Back up Subpart C – Electronic Signatures (3 of 3).

3) A predicate rule is any FDA regulation that requires companies to maintain certain records and submit information to the FDA as part of compliance. 4) Regulatory action means any action required by the predicate rules or by the valid quality system..

Back up Compliance Companion Tool. Compliance Companion is a centralized, coordinated service to support the business, project managers, change managers, and application managers regarding SHS compliance topics. The Compliance Companion tool must be used for IT managed applications to assess relevance of these compliance topics. Additional Compliance Companion Tool Training with the ITSM_Compliance Companion User Guide is available in Learn4U. The Siemens Healthineers business must provide IT with the information/requirements (per QIA4) to determine compliance topic relevancy..

Back up Q-Aspect Detailed Workflow. 21 CFR Part 11 Officer SHS IT | SHS IT ST QGC QS.

undefined. Electronic Records; Electronic Signatures.