Integrated Document Management: Leveraging Technology to Improve Compliance and Efficiency

Sparta Systems

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. 

Document Management 

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. 

Secure Storage 

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. 

Reporting 

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.