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Achieving Success with Electronic Document Management

Electronic Document Management or EDM is typically defined as a secure way to organize, control, search, access, and archive digital files. Companies from start-ups to the Fortune 500 implement EDM solutions in workgroups, departments, divisions, and across the entire enterprise. Whether the company puts a single EDM solution into practice or multiple solutions that interoperate (“talk to each other”) depends on the type of business, the regulatory environment in which the business operates, its core requirements, and the resources (human and financial) available to manage the EDM system(s).

There are six primary benefits to EDM systems. They:

• Create cost savings.
• Secure the data.
• Satisfy regulatory requirements.
• Provide easy data access.
• Enable disaster recovery.
• Ensure procedural consistency.

Let’s briefly explore each of these benefits.

Creating Cost Savings

EDM systems help you realize cost savings in various ways. According to studies conducted by Forbes ASAP, the average professional spends 150 hours a year looking for documents. If you assume that this professional’s time is valued at $50 per hour, that means $7,500 is wasted per year per individual just in searching for documents. Many of these costs can be immediately eliminated with a good EDM system. These systems can also eradicate costs that go to recreating lost or misfiled documents. Yet another way to save costs is by eliminating file cabinets that take up physical space. With real estate prices always increasing, an electronic document management system can free up valuable space for other purposes.

Implementing security for your files and documents is one of the most pressing issues in today’s workplace. News articles of data leaks, data threats, and compromises of confidential and sensitive data seem to make headline news every day. Keeping files safe from the competition, thieves, and ill-natured employees is an ongoing business requirement. Electronic document management systems allow you to prevent these events from happening. Various levels of protection through passwords and biometrics prevent unauthorized access to files and folders. The systems can even hide specified cabinets and folders so they seem to be non-existent. Encryption can provide impenetrable security, even if someone happens to get away with theft. Detailed audit trails track all activities and file access, providing a complete log of all document transactions.

Satisfying Regulatory Requirements

Depending on your industry and geographic location, there can be local, state, national, and international regulatory requirements that your company must satisfy in order to conduct business, provide services, and sell products. US companies must adhere to the requirements of Sarbanes-Oxley, California SB 1386, Gramm-Leach-Bliley, HIPAA, and the Family Educational Rights and Privacy Act (FERPA); financial services firms must contend with SOX and SAS 70; and biotechnology and pharmaceutical companies selling products in the US must comply with regulations set by the US FDA, while EU countries are governed by the European Medicines Agency. A carefully planned EDM strategy, followed by a thoughtful implementation, can help your company demonstrate compliance with stringent regulatory requirements.

Providing Easy Data Access

Ready access to mission-critical documents is essential for all businesses. However, as mentioned before, the data must be secured so that only specified employees have the required access. Most employees inside technology companies use a host of different systems such as LANs, WLANs, intranets, and extranets for accessing mission-critical data. These systems provide direct access when users are on the network backbone or secure, remote access with a key fob or biometric. In my experience, most small tech companies do not use a broad-based EDM solution due to the purchase and maintenance costs, while medium-sized and large companies consider the financial commitment a cost of doing business.

The standards and processes for the creation, submission, and retention of regulatory documents are critically important to the pharmaceutical industry. The Drug Information Association holds an annual conference on EDM in both the US and Europe. I attended the 7th annual European conference in Berlin last December and will be attending DIA’s 20th anniversary US conference in Philadelphia in February. The move away from paper to electronic submissions has been gradual and steady, with the US far ahead of Europe. The need for ready access to critical information contained in the submissions must never jeopardize public safety.

Enabling Disaster Recovery

Every business should have a disaster recovery plan. Electronic document management systems provide multiple ways to ensure that your business does not get crippled after a disaster. One method is by providing onsite data backup and an additional backup for offsite storage. Another is exporting the data, along with a repository map of the data, to another location. By storing the data and repository map offsite, you can place the data onto new systems more efficiently (in terms of both time and cost) compared to having to re-create the data.

Ensuring Procedural Consistency

Using an EDM system encourages the development and maintenance of standardized processes within an organization. Ensuring procedural consistency involves writing and updating SOPs (Standard Operating Procedures), WIs (Work Instructions), BPMs (Business Process Maps), and validation documents. By using business process modeling applications, companies can create visual maps of their processes, people, hardware, and software. Together, these documents and maps show how a business accomplishes a specific task or set of tasks, and, most importantly, they reflect how the company works.

Bottom Line

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Founder and Manager
Tim Rosa Associates, LLC

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