To properly control quality, an organization must be effective at controlling its quality documentation.
Document control and management are vital to achieving and maintaining compliance in regulated environments. Forms and procedures must be accessible to those requiring them at any time, while critical records, including non-conformance reports, test analyses, and audit results, must be strictly controlled to prevent unauthorized access and modification or deletion. In many cases, document control is a full-time job for one or more employees within a business.
To help streamline the document control system, many companies have developed document control software that allows an organization to maintain and control access to its documents. Whether or not a small business should invest in document control software depends to a large extent on the complexity of the quality management system in place, the number and relative availability of employees to perform the task, and the end product of the business. Document management software is not needed in every organization, but for most, it can be a helpful addition, if not a direct contributor to the bottom line of the business.
Document control software can be as simple as a stand-alone repository for a business’s policies, procedures, records, and documents, or as complex as a fully integrated application with notifications through email systems.
It can route documents for review and approval, send reminders of corrective actions overdue, assign new corrective actions, notify employees when training is required, and notify quality managers when equipment calibrations are due. The system can be housed completely internally on one PC workstation, or stored externally on a client-based web application or in a cloud environment.
When a document control software solution is properly designed and implemented, it can provide a return on investment for a business. By carefully selecting and deploying components of such a system, administration of a document management system is drastically reduced, freeing employees formerly tasked with the responsibility to take on other responsibilities within the organization, thereby eliminating overhead. In some cases, it may be possible to reduce total organizational headcount.
Document searches can be completed quickly, saving time. Moreover, it improves the accuracy and reliability of the storage process, and can decentralize the system to allow users remote access to procedures and documents, improving the productivity of an organization.
Before any business, large or small, decides to invest in document control software, it should carefully assess its current document handling processes, and determine, in detail, exactly what it expects of a document control application, as well as its current electronic storage capabilities.
Small businesses will likely be successful with an existing off-the-shelf application and a single dedicated PC, while large companies may need to invest in customized software and a server, or contract for off-site data storage. It is critical for both simplicity and cost management to only purchase those portions of a system which are useful and add value to the organization. Investing in a large suite of document control modules that do not fit the needs of the business is wasteful, and overly complicates the software, training, and end use of the product.
Businesses investing in document control software should look for an application that is scalable with the business. Applications that can be integrated into an existing office suite are preferred for training and compatibility reasons, but are not necessary. Independent applications may afford the business with more capabilities, such as email reminders and automatic scheduling and approval routing. Regardless of the application chosen, it should have the ability to sign documents electronically, provide access control and password protection, and create an audit trail that can easily be followed for internal and third-party audits of the quality management system.
Small businesses will find that document control software applications exist in abundance that integrate easily with Microsoft Office and other business software suites. Some of the applications also exist as shareware or freeware, making their cost to the organization nil. In many cases, the same small business can use a stand-alone PC to house the application, and designate an individual within the organization to perform daily or weekly database back-ups to DVD for storage off-site or in a fireproof safe for records retention and business continuation purposes.
An independent PC with document control software also prevents hacking from outside intruders, and can be programmed for individual password access to specific documents and forms housed on the unit.
An investment in this type of hardware and software will be relatively small and affordable for the small business and will produce quick return on investment (ROI), yet will still enhance the quality management system requirements for document control and storage while at the same time allowing employees to be quickly trained to begin using the system.