A document control system is officially defined as a collection of interconnected procedures, workflows, and software products used in the development and marketing of paperwork within an organization. That being said, the term is frequently used synonymously with electronic document management systems (EDMS), which are the systems used to store, organize, monitor, share, and analyze the data and files of an organization.
To make matters even more complicated, document management systems are, at their root, storage systems. Some of the famous EDMS examples are Google Drive, Dropbox, Microsoft SharePoint, Microsoft OneDrive, Egnyte, eFileCabinet, DocuWare, and Citrix ShareFile.
More Than A Checklist:
A document control system’s basic standard is met by a documentation process that adheres to the guidelines mentioned earlier. Following that, it is common for businesses to create their practices and systems for managing documentation utilizing paper-based, digital, or a combination of different types of tools to meet regulatory requirements. However, using a paper-based or hybrid system to comply with regulatory standards can negatively affect your manufacturing timelines and time to market. Producing revisions, forwarding documents for approval, and tracking down or redrafting missing documents are the most time-consuming aspects of the product’s life cycle.
The Need For A Document Control System:
There are numerous possible responses to this question. The first is because it makes sense. Documentation is essential in every organization, and needing apps and guidelines to ensure it will most likely improve its quality and efficiency, and productivity.
The second reason is about what an organization needs on a regular basis or a case-by-case basis. A company merger, for example, is a situation that necessitates comprehensive document control. Finally, the third response addresses specific and inevitable requirements, such as ISO standards. In these situations, document control is required to acquire the optimal accreditation.
- Competent Access Control:
In competitive markets, DCS can implement robust and compatible identity and access management (IAM) practices to ensure that only the authorized people have the proper access at the right time. Paper-based systems or ineffective paper-free methods can implement risks of data loss in the lack of transparent access governance. Data leakage exposure in highly regulated industries could fail to comply, loss of competitive edge, brand damaged reputations or other risks.
Document control systems must play a significant role in identity and access by keeping sensitive documents out of the grasp of the wrong people. They should also allow authorized parties to quickly check, find, and recover archived and active documents when necessary. Storage for numerous document types, including specific Pdf files and spreadsheet applications, universal, easy-to-use keyword-based search, and access restriction based on customer identity or role, are some of the ways a DCS can support data transparency to the affluent user.
In heavily regulated industries, quality management systems are an essential component of conformance and reliability culture. While quality management is a multidimensional practice, document control is critical in driving cGMP adherence for SOPs, organizational policy, and other essential quality processes. A document control system is required if your organization is regulated by the FDA, EudraLex, or ISO. Aside from lowering risk, a paperless method to DCS can boost efficiency and more innovative procedures for approval, document storage, and availability.
Production delays are almost always guaranteed when there is a data accuracy conflict, an approver is inaccessible, or a document is lost. Paper-based document control systems are susceptible to many errors and nonconformances due to their many moving parts. Many organizations are migrating to digitized document control systems to eliminate document-related breaches and manufacturing hiccups. To learn more on the concept of Document Control System, contact Docupile.