Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices? We understand! read below to learn about some document control systems that can help make almost any business more efficient.
Due to the very nature of the regulations and requirements for the medical device industry, and a plethora of documents that are generated when developing, marketing, or maintaining a medical device; a Document Control System (DCS) would facilitate the creation, review, modification, and access of the documents throughout their lifecycle is very much required.
Implement DCS for following:
- Retrieval of information and documents
- Control over documents
- Traceability and no duplication
- Protection of company interests during an incident or an installation
- Auditability
- Compliance with industry standards and regulatory requirements
- Information protection
Everyone sooner or later concurs that Document Control is something important; the question is should the DCS be an electronic system or paper?
Someone rightly said:
“It is very hard to transform your culture and your workforce to be a relevant company in the digital world if all of your processes are stuck in the traditional world.”
ince everything today is getting digitized, with its obvious advantages, you can choose from some very good Electronic DCSs. Even though e-DCS is not a new concept and has been there for a while, but companies are now, more than ever, moving towards cloud-based DCS which can be accessed almost from anywhere across the world. The key milestones of a typical e-DCS workflow includes creation, review, approval, release, and storage.
Here is a quick summary of some useful features of common e-DCS:
- The Agile PLM of Oracle enables management and maintenance of documents for the complete life cycle of a product. The platform has the capability to document safety specifications, SOPs, training records, and product records. This solution has been around for a while and has been successfully used by many medical device companies
- ZenQMS of ZenQMS LLC is another good tool that enables SOPs, work instructions, policies, and general documents uploads. The tool does not offer any restrictions on file types or sizes and is quite economical in terms of storage and user seat license. The tool offers issue investigations, audit and supplier management, enables external supplier related activities and manages all the internal regulatory audit processes. ZenQMS also offers training content that can be assigned to any group or section along with a tracking option
- Arena Solutions offers Arena another robust tool that provides efficient access and collaboration through storing, sharing and tracking documents. The system provides secure access and offers good compliance to requirements with minimal user training
Almost all of these solutions are primarily for document review, approval and storage and don’t offer other features such as CAD systems tools for analysis, simulation or visualization. In Spite of the various useful attributes that each of these platforms offer there are some limitations like inability of allowing effective multi-user collaboration for comment, review and approval on the same document without uploading and routing it again for approval and release. Some users report certain DCS to be not very user-friendly and not providing access to features that enable customized searches; whereas some report that DCS does not provide them Bill Of Materials (BOM) feature to add subassembly of a device. But, no system is perfect, and it is important to identify and deploy a system that would most effectively address your requirements.
With all the excellent tools that we can get our hands at today, the importance of human intervention is not undermined, but, it is now all the more important to have a competent, well trained, sincere and honest Document Controller to take charge of the e-DCS.
Elexes has provided dedicated DCS assistance with a strong emphasis on compliance and traceability for small and medium sized companies. For more information, email us at contact@elexes.com.
Effective DCS is essential to revolutionize modern medical device businesses. Revisit your document control system today and make the right choice.
