Marci Lynn Crane asked:


When you consider the relationship a life science company shares with the FDA it’s easy to visualize the love/hate kinship of a parent and child. It’s also simple to deduce who the parent might be. After all, the FDA Mama or Papa Bear has never been shy when it comes to playing by regulatory rules.

The Goals of Life Science and the Goals of the FDA: Mutually Compatible or Mutually Exclusive?

The goals of a life science company are likely to include the development, manufacture and sales of the best and most useful biotech equipment, medical devices, drugs, etc. The goals of the FDA include safety, the transparent communication of possible dangers or uncomfortable side effects, and the viable effectiveness of products produced. Each set of goals is noble and in theory supports the goals of the other. In practice however, the goals of these separate institutions seem almost mutually exclusive.

Change Control Software: Middle Ground for Two Separate Powers

Like most solutions to apparently irreparable problems, the solution that allows both life science companies and the FDA to find a cheerful middle ground is the solution that benefits both organizations. This solution includes the implementation and use of change control software. Change control software is valuable for the simple reason that it allows life science companies to artfully manage (without spending ridiculous man-hours) those changes that occur at any stage of a product’s development or manufacturing processes. Documentation, routing, tasks and employee accountability are also concerted via a solid change control software solution.

The benefits of a change control software solution are many but to truly understand these benefits it’s beneficial to first understand the problems that often maintain many life science professionals in a state of “regulated” frustration.

The Problems

Among the problems that lie within the walls of many life science companies is the problem of change management processes that are controlled 1) manually or 2) with a hybrid/decentralized solution. Most companies simply want to save their hard earned ROI, but when considered carefully it’s easy to see that manual and/or hybrid solutions won’t save companies money in the long run, and in addition, present a variety of problems that might have managed to stump even Solomon the wise.

Manual and Hybrid Solutions: Problems that Contribute to Greater Problems

Listed below are some of the problems that life science companies can avoid with a digitized and centralized change control software solution.



High Costs—Life science professionals may think they save money with a paper-based system but in all reality they spend a great deal to pay for the tedious man-hours spent on the manual routing of documents, the document approval process and on manual search and document retrieval (if the document can actually be found). A change control software solution however manages to automatically route documents, seek the appropriate approvals/electronic signatures, search for documents and retrieve them.

Validation Procedures—The FDA requires that processes (this includes change processes) be validated. If a life science company has to validate their processes manually it can be a far greater challenge than some companies care to undertake. Electronic validation presents a far more effective alternative that saves time, money, and effort. In the long run, manual validation can also cost more than a centralized solution. When searching for change control software, ask the software sellers if automated validation services are available.

No Centralized Location—A paper-based system doesn’t allow life science professionals to maintain, protect and organize documents in one digitized and centralized location. A commendable change control software solution digitizes and centralizes information so that life science associates can find the organized information they need—when they need it. A good change control software solution will also manage almost any type of file required throughout any of the GxP processes.

Document Revision Processes—When change inevitably occurs the manual document revision process can be faulty in the extreme. Life science employees will unfortunately be subjected to manual searches for documents, and will be required to manually make changes on documents or SOPs. A good change control software solution however can provide revision control that is automatic and centralized so that once submitted, documents can be routed and approved quickly and effectually. Change tracking will also be automatic.

Also, when searching for the change control solution that will fit the needs of a life science company, professionals should look for a solution that is 1) customizable to their needs and that 2) require form explanations for changes that are being made. Accountability, after all should be an important aspect of change control.

A Picnic in the Park

Change control can take life science professionals one step further to a change management process that could potentially be compared to a picnic in the park.

Dmitry Costenco asked:


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