Quality is essential for manufacturers in regulated industries, such as Life Sciences, to ensure the safety and efficacy of their products and to comply with industry regulations. However, managing and controlling the large number of documents required to be compliant with these regulations can be a significant challenge.
One solution to this challenge is to implement an integrated approach to quality, leveraging technology to improve compliance and efficiency.
One of the key components of an integrated approach to quality is document management. Document management technology can help manufacturers automate the process of creating, reviewing, approving and storing documents. This can help to reduce the risk of errors in the manufacturing process and ensure that all necessary documents are readily available for review by regulators.
Additionally, many regulators, such as the FDA, now accept electronic submission of documents. Document management technology can help manufacturers prepare and submit these documents electronically, making it easier to submit the documents in a timely manner.
Auditing and Tracking
Another important component of an integrated approach to quality is the ability to track and audit changes made to documents. This can be useful during a regulatory review as it allows manufacturers to demonstrate that documents have been reviewed and approved by the appropriate personnel and that any changes made have been properly documented.
In regulated industries, manufacturers must ensure that sensitive information is stored securely. Document management technology can help manufacturers to store documents securely, protecting sensitive information from unauthorized access.
An integrated approach to quality should also include the ability to generate reports that can be shared with regulators. Reports can include information on the approval status of documents, changes made to documents, and compliance with regulations.
Meet Compliance and Reduce Risk by Taking an Integrated Approach to Quality
An integrated approach to quality, leveraging technology to improve compliance and efficiency, is essential for manufacturers in regulated industries. Document management technology, auditing and tracking, secure storage and reporting are key components of this approach. By implementing these solutions, manufacturers can meet compliance and reduce the risk of errors in the manufacturing process.WATCH MORE ABOUT DMS
Resources About Document Management Solutions:
- WHITE PAPER: An Integrated Approach to Quality – How to Tighten the Connection between Quality Management and Document Management.
- DATASHEET: TrackWise Digital Document Management – Manage Quality Documents from Anywhere.
- LEARNING: Course: TrackWise Digital Document Management System – This eLearning OnDemand course is for those new to the TrackWise Digital Document Management System (DMS) application. The course provides an overview of DMS as a document management tool.
- REFERENCE: TrackWise Digital Document Control Software – TrackWise Digital document control software keeps all your documents in a single, centralized location, helping you combine quality processes and more easily achieve regulatory compliance.