by Marci
Americans are familiar with the concept of waste. Since grade school their brains have likely pondered (only for brief moments of course) statements that may resemble the following:

• Americans waste 10 times more biodegradable material than do the Japanese.
• Americans waste 20 times more (per capita) non-biodegradable material than do per capita units within the U.K.,
• Etc., etc.

Regardless of whether or not these statements are true, the concept of waste is a familiar one in the U.S. However, waste, like most problems, is a controllable issue and one that is changing rapidly in the face of emerging technologies.

Life Science Companies and Waste

Regulated life science companies are one of the key industries that stand to reduce vast amounts of paper waste with the help of electronic systems (i.e. computers and software). Why? Because regulations (FDA, ISO, CLIA, SOX, etc.) and efficient quality control systems require increasingly large amounts of documentation, which unfortunately is often routed and approved by life science companies in hard-copy form. The FDA however in regulation 21 CFR Part 11 states [statement paraphrased] that electronic signatures and approvals can now be considered as equally valid to those on hard copy paper work, which for life science companies, means that paper work can (and should) be digitally remastered, not only to prevent vast amounts of waste but to save valuable man hours as well.

Search for Change Control Software

When searching for a change control software solution there are many factors to consider. As a life science or high-tech representative, you may choose to consider the following aspects when contemplating the purchase of a potential change control software solution:

1) Web-Based Functionality

When searching for a change control software solution, consider a web-based solution. A web-based solution allows in-house employees to access the change control system from virtually anywhere and also allows 3rd parties (such as suppliers) to access the system as well when approved.

2) Connectivity

Change control is not a “lone entity” process. In fact, change control is closely related to other quality control processes such as CAPA (Corrective and Preventative Action), nonconformance management, deviations management, customer complaints handling, audits, training, etc. For best results, look for a solution that can be integrated with additional (and essential) quality control solutions.

3) Forms Control

Since forms, or documentation, are the lifeblood of the change control process, it is essential that forms be controlled from start to finish. Look for a solution that tracks forms electronically from start to finish.

4) Forms with Priority Levels

In addition to electronic forms management, search for forms that automatically identify priority levels for change control tasks (i.e. a task that can wait vs. an emergency).

5) Centralized Archive

Search for a change control solution that provides a centralized archive for electronic forms. A centralized archive makes forms easier to locate and retrieve.

6) Accountability Features

A problem among many manual change control processes is a lack of easily searchable who, what, when, where, and why documentation. Make sure to shop for a change control solution that includes accountability and easy-search features. For example, when an approved user makes a change to an electronic change control form, there should be a form field that requires user justification. The tracking features and centralized archive will also ensure that the whos, whats, whens and whys are never a hidden secret.

Conclusion

Decrease the waste that is so prevalent within the life science industry by investing in change control software and additional quality control solutions.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information regarding a change control solution, please feel free to contact a MasterControl representative.

Article Directory: Article Dashboard