Sometimes the most important step in a successful product launch is knowing where the documents are—getting delayed by not being able to find the documents the FDA insists on seeing (or worse, having to start over) is a major drag. The same is true when it comes time for an FDA audit.
That’s why an effective document management system (DMS), an integral component of an enterprise content management (ECM) system, is critical for any organization. This is especially true for companies with multiple sites in different countries.
DMS is a software program that can be customized to easily store, track, and access electronic documents, including e-mails. This reduces the possibility of losing documents, pulling wrong documents (or drafts of documents), and storing multiple documents.
According to Basex, almost $1 trillion in worker productivity is lost annually as a result of dealing with records and documents. When a company establishes a user-friendly DMS, worker productivity goes up, document maintenance costs go down, volume is easier to manage, and workers are less stressed and happier.
Go to the Cloud
Storing and retrieving documents from the “cloud” (secure, off-site data storage facility with redundant systems that is run by an IT vendor) is increasingly becoming a preferred way to manage a document system. Benefits include:
- No need to purchase, install, manage, and maintain your own on-site system and overwork your IT department, or hire more IT professionals
- Documents can be accessed 24/7 from anywhere with a mobile device, including laptops, tablets, and smartphones, greatly increasing efficiency
- Only pay for the DMS services that are required
Step up Efficiencies
Data Management Solutions can be customized for each company’s specific needs for creating, storing, managing, and sharing documents throughout the enterprise, including the supply chain. DMS greatly reduces human error in document management, including confusion over different versions and approvals. A DMS can be configured to provide a checklist of all the documents required for regulatory approval—which speeds up the approval process by making sure every submittal has the proper documentation attached. This also reinforces the FDA’s confidence in the company’s quality management system.
Internal regulatory requirements are also enhanced with DMS, such as being sure employees and managers sign off on reading documents and SOPs (which greatly reduces the risks of employee misunderstandings, or even HR-related litigation, down the road).
Document management systems are also vital for facilitating compliance with various internal and industry standards and regulatory requirements including FDA, cGxP, ISO 9000, ISO 13485, ISO 14000, ISO 14971, Sarbanes-Oxley sections 404 and 302, EU directives, and International Health Ministries.
Ultimately, DMS improves communications between departments, breaking down siloes and improving transparency. Document templates ensure consistency and that all relevant data are requested and accounted for. Deadlines for revisions and approvals can be tracked, making it easier to coordinate changes, provide up-to-date information, and manage evolving schedules. All of these capabilities increase collaboration and help establish best practices that unite all departments.