Qualityze Achieves ISO 9001:2015

Tampa, FL – January 30, 2020 – Qualityze, Inc. has been certified as ISO 9001:2015 – compliant after an in-depth audit of the company’s internal operations.

21 CFR Part 11

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?

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 Compliant QMS Software?

Some of the benefits of having 21 CFR Part 11 Compliant QMS Software.

Qualityze Solution Information Matrix for 21 CFR 820

Qualityze eQMS is designed to help an organization to comply with 21 CFR 820.
The following matrix will provide essential information for you to understand how Qualityze Solution can help:

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:

The printed name of the signer;

The date and time when the signature was executed; and

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.