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The organizations especially the ones in a highly regulated industry – including biotechnology, lifecsiences, pharmaceuticals, medical devices, etc. – need to comply with FDA 21 CFR Part 11 to control the validation and verification processes, audits, audit trails, eSignatures, SOP, and other software documentation. However, it makes the implementation of an effective document management process little difficult.

What is 21 CFR Part 11 Certification?

Title 21 CFR Part 11 establishes the United States Food and Drug Administration (FDA) standards for the electronic records and electronic signatures (ERES). It basically defines the set of rules under which the electronic records, as well as electronic signatures, will be considered as trustworthy and reliable as paper records.

An organization that wants to meet the compliance requirement of FDA 21 CFR Part 11 can;

  • Implement a paper-based approach,
  • Implement a Document Management System specifically designed for validation and verification purpose across highly regulated industries.
  • Implement a Document Management System that is specifically designed to comply with Part 11, or
  • Implement a Quality Management software, which is integrated with compliant features for document management.

All the compliance requirements defined under 21 CFR Part 11 are mandatory for medical devices and pharmaceutical companies. Qualityze Document Management System is specifically designed to help your organization to maintain Part 11 compliances with the features like Electronic Signatures, Audit Trail, Reports, Collaboration, and Approval for Standard Operating Procedures (SOPs), Work Instructions, Manuals, Policies, Procedures, Files, etc.

What are the benefits of having 21 CFR Part 11 Certified QMS Software?

Some of the benefits of having 21 CFR Part 11 Certified QMS Software:

Higher Level of Integrity

With a 21 CFR 11 Certified QMS Software like Qualityze, you can ensure a higher level of safety, security, and integrity for the data and information you store and share on a daily basis. You can use the electronic signature to validate and verify the document authentication state.

Reduced Data Errors

Once you will have a document management system with Part 11 compliant features, you will have improved process for version control. This ensures neither you nor your team will refer to an old document when a new revision is already released. Hence, there will be fewer data errors.

Lowered Document Management Cycle

Having an FDA-compliant document management system implemented in the organization, you will have streamlined workflows, well-structured approval process, centralized document access, improved process control, and much more that will consequently lower the document management cycle time.

Improved Information Transfer

If you will have a compliant document management system in place, you will be able to manage all your critical documents in a centralized database wherein all the authorized team member will collaborate and communicate for managing document changes in a controlled manner. This will ensure that the best version of the information is shared with the users.

Value Addition to the QMS

When only quality data and information will be processed through a compliant document management system, you will be able to make better and informed decisions. It will add more value to your quality management system with the filtered and updated information inputs every time.

Do you want to establish a compliant document management process in your organization? Get Qualityze document management solution. Or, you can opt for Qualityze EQMS for improved quality management processes based on desired regulatory requirements.

21 CFR Part 11 is a US FDA Code of Federal Regulations (CFR) guideline for a computer system that is used to manage and store electronic records and electronic signatures. It helps companies to define the rules under which electronic signatures and records are considered to be original, accurate, trustworthy, confidential, reliable and equivalent to paper records and handwritten signature.

21 CFR Part 11 Requirement Does Qualityze Comply? How
The system must be capable to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying. Yes Qualityze suite comes with broad range of key reports and quality metrics. Additionally, Qualityze provides capability to create custom reports. All these reports can be printed in paper or downloaded in electronic format.
Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Yes Qualityze’s Software Test Lifecycle process was designed to support the FDA’s guidelines.  A lot of rigor and process is in place to ensure the accuracy, reliability, and performance of the system.
Limiting system access to authorized individuals. Yes Qualityze is designed with security in mind. The system requires a unique user id and password to gain access. Also, access to different modules and function are controlled with a combination of roles and rights.
Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available Yes Qualityze keeps the history of all the activities that the user performs in relation with Insert, Update and Delete of all the transactional records.
Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. Yes Qualityze system provides the capability for the customer to pre-define the sequencing for each record. Once the sequencing is defined, the system will ensure that the pre-defined steps are executed as specified. Also, the system comes with pre-defined validation rules to enforce the execution of the pre-defined sequence.
Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. Yes Qualityze system requires a unique user id and password to gain access. Also, access to different modules and function are controlled with a combination of roles and rights. When a record is generated, altered or modified, besides the audit trail, in some steps user id and password is required to be typed again to complete the steps.
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

  1. The printed name of the signer;
  2. The date and time when the signature was executed; and
  3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
Yes Qualityze suite captures the date/time and the user information (signer’s name, role) and the meaning of the signature.

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