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The effective management of quality documents such as SOPs, change controls, quality records, work instructions, is crucial to a quality organization.
The Organization knows that a manual and paper-based system to manage quality documents is inefficient, costly, and unsustainable.
Qualityze leverages the latest cloud technology to offer the best in class Document Management Software Solution (QDMs). QDMs is robust, an easy-to-implement and complements your established document management process to,
With functionalities such as email approval, collaboration tools, electronic signature, revision control and many more, accelerates review and approval cycles of a document. A profile-based access controls, allows only the right people to have access to the right documents.
Audit trail records all document access and every change made to records, documents, or data fields to improve overall regulatory compliance.
QDMs integrates seamlessly with other Qualityze modules to form a closed loop system. Document changes can be initiated as a result of CAPA, audit findings, customer complaints. Additionally, document revisions (e.g. policy changes, work instruction changes), in turn, can trigger training requests for the impacted employees.
Qualityze’s document management software has powerful analytics and reporting capability with graphical dashboards help to track each document from origin to obsolescence, giving managers complete visibility into the system.
Create and Collaborate
The document creation process involves utilizing standard templates to keep the consistent and efficient process. Additionally, different people are necessary to collaborate during the document creation process. Qualityze Document Management system makes this process easy for you. A standard template can be used to generate a document. In the Initiation step, you capture information such as,
- Effective Date
- Expiration Date
- Security information and others
You can also use a ‘check-in’ functionality to store a completed document. Collaboration step is an optional step in which a document owner can invite several people to participate in the creation process of the document.
Review and Approve
According to regulatory standards, once a document has been drafted, a designated individual(s) should review for adequacy of the information and approve prior to issuing the documents.
In Qualityze you can also use the collaboration step to perform the review process. Alternately, approval process can also be used for a review process even though it is an optional step in the system.
Once the document has gone through the initiation, collaboration, review and approval process, it is time to release the document for the end user.
In Qualityze, the release process is simplified. When setting up the document profile, you have an option to define the grace period which is used to control the release process. A document can be released as soon as the approval process is complete. If the effective date is in the future, the document will not be released. Additionally, a built-in review process can be scheduled to periodically check the validity of the document. As a part of the effectiveness review, you have the option to keep the document active or revise or expire.
Obsolete and Archive
As a part of the document lifecycle process, documents are constantly assessed for the validity of the content. When a document is revised, a new revision is created. In this case, the old revision is made obsolete to remove it from the circulation. Even though the old revision is withdrawn from the circulation, it needs to be archived based on the company’s record retention policy.
In Qualityze, making the document obsolete and keeping it archived is simple. As a part of the document profile, you can pre-define the number days after which the status of the document changes to ‘Obsolete’.