Document Control in LuitBiz QMS

One of the most important quality processes in a regulatory environment is document control. It is a major hurdle in most companies. The document control feature of LuitBiz QMS is very flexible, easy to use and yet addresses the world's most stringent regulations and standards to ensure compliance. The document control feature of LuitBiz QMS reduces overall compliance costs and increases efficiency to accelerate time to market and be audit ready.


Document Control Challenges and how LuitBiz QMS can help

Without LuitBiz QMS

With LuitBiz QMS

Manual document control is highly inefficient as it requires a lot of man-hours in terms of routing documents, obtaining approval and signatures, face-to-face meetings to discuss changes, and search and retrieval of documents during inspections and audits.

Increased Efficiency
The document control feature of LuitBiz QMS automates routing, delivery, escalation, and approval of documents. Documents can be created in LuitBiz QMS and they are stored in a centralized, secure repository that makes search and retrieval easy

Lack of Standardized Document Formats
Quality documents need to follow certain formats while they are being prepared. In manual document control processes, it is impossible to prepare documents in standardized formats. This results in various formats of the same document floating around that poses a big challenge during compliance audits

Standardized Document Formats
In LuitBiz QMS, document preparation templates can be created in the system by the QMS Manager. The writers can then write documents using those templates. This helps in standardizing document formats and makes the documents audit ready.

Inability to write, approve, and publish documents online
Using a manual process, it is not possible to ensure that all the activities of writing, approving, routing and distribution of documents are taken care of in the same system. This results in misplaced documents and distribution of obsolete document versions to the users

Write, approve, and publish documents online
In LuitBiz QMS, document request, preparation, approval, and routing are handled centrally ensuring that the latest controlled copy of the documents are distributed to the intended audience.

Lack of Revision Control
Employees manually check out documents in a hybrid or paper-based system. Tracking down any document activity is a huge challenge under these conditions. Even a small change request requires manual submission of the request or discussion of the change in face-to-face meetings.

Automated Revision Control
The document control feature of LuitBiz QMS provides automatic revision control to ensure that only the current controlled version of a document is available to the intended viewers. Access to the prior revision is cut off when a new version of the document is published. The system allows QMS Manager to track the usage of controlled documents.

Disparate Systems
Most companies have different systems for document control, process control, and other processes. These systems and the people using them are not connected increasing the likelihood of miscommunication. Quality process tasks are likely to fall through the cracks from one disparate system to another.

Connected System
In LuitBiz QMS, you can control documents, SOPs and the quality forms like CAPA, Change Control, Deviation, Complaint, etc. using a single system. This ensures that all the stakeholders of the quality management process are on the same page

Unprepared for Audits
Audits and inspections are performed on all significant records pertaining to a product's design and production. Paper documents are difficult to track and are prone to loss in a manual procedure. Nothing is more frustrating than being asked to produce a crucial document during an audit.

Always audit ready
The Document Control Feature of LuitBiz QMS provides a centralized, web-based repository for all documents essential to compliance. For everything they require, auditors will only need to look in a single software. Document retrieval, tracking, and search are all made simpler by automation.

Lack of Collaboration
Collaboration in a manual process requires getting all parties involved in one place. This is a very is time-consuming process. Writing collaboratively might be possible, but emailing a document request and its approval around is ineffective.

Efficient Collaboration Process
Users of LuitBiz QMS Document Contral can collaborate virtually in real time from anywhere, anytime, using any device connected to the Internet. Hence physical location no longer can cause delays in collaboration.



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