| When you consider the relationship a life science | | | | High Costs- |
| company shares with the FDA it's easy to visualize | | | | Life science professionals may think they save money |
| the love/hate kinship of a parent and child. It's also | | | | with a paper-based system but in all reality they spend |
| simple to deduce who the parent might be. After all, | | | | a great deal to pay for the tedious man-hours spent |
| the FDA Mama or Papa Bear has never been shy | | | | on the manual routing of documents, the document |
| when it comes to playing by regulatory rules. | | | | approval process and on manual search and |
| The Goals of Life Science and the Goals of the FDA: | | | | document retrieval (if the document can actually be |
| Mutually Compatible or Mutually Exclusive? | | | | found). A change control software solution however |
| The goals of a life science company are likely to | | | | manages to automatically route documents, seek the |
| include the development, manufacture and sales of the | | | | appropriate approvals/electronic signatures, search for |
| best and most useful biotech equipment, medical | | | | documents and retrieve them. |
| devices, drugs, etc. The goals of the FDA include | | | | Validation Procedures- |
| safety, the transparent communication of possible | | | | The FDA requires that processes (this includes change |
| dangers or uncomfortable side effects, and the viable | | | | processes) be validated. If a life science company has |
| effectiveness of products produced. Each set of goals | | | | to validate their processes manually it can be a far |
| is noble and in theory supports the goals of the other. | | | | greater challenge than some companies care to |
| In practice however, the goals of these separate | | | | undertake. Electronic validation presents a far more |
| institutions seem almost mutually exclusive. | | | | effective alternative that saves time, money, and |
| Change Control Software: Middle Ground for Two | | | | effort. In the long run, manual validation can also cost |
| Separate Powers | | | | more than a centralized solution. When searching for |
| Like most solutions to apparently irreparable problems, | | | | change control software, ask the software sellers if |
| the solution that allows both life science companies | | | | automated validation services are available. |
| and the FDA to find a cheerful middle ground is the | | | | No Centralized Location- |
| solution that benefits both organizations. This solution | | | | A paper-based system doesn't allow life science |
| includes the implementation and use of change control | | | | professionals to maintain, protect and organize |
| software. Change control software is valuable for the | | | | documents in one digitized and centralized location. A |
| simple reason that it allows life science companies to | | | | commendable change control software solution |
| artfully manage (without spending ridiculous man-hours) | | | | digitizes and centralizes information so that life science |
| those changes that occur at any stage of a product's | | | | associates can find the organized information they |
| development or manufacturing processes. | | | | need-when they need it. A good change control |
| Documentation, routing, tasks and employee | | | | software solution will also manage almost any type of |
| accountability are also concerted via a solid change | | | | file required throughout any of the GxP processes. |
| control software solution. | | | | Document Revision Processes- |
| The benefits of a change control software solution are | | | | When change inevitably occurs the manual document |
| many but to truly understand these benefits it's | | | | revision process can be faulty in the extreme. Life |
| beneficial to first understand the problems that often | | | | science employees will unfortunately be subjected to |
| maintain many life science professionals in a state of | | | | manual searches for documents, and will be required |
| "regulated" frustration. | | | | to manually make changes on documents or SOPs. A |
| The Problems | | | | good change control software solution however can |
| Among the problems that lie within the walls of many | | | | provide revision control that is automatic and |
| life science companies is the problem of change | | | | centralized so that once submitted, documents can be |
| management processes that are controlled | | | | routed and approved quickly and effectually. Change |
| 1) manually or | | | | tracking will also be automatic. |
| 2) with a hybrid/decentralized solution. | | | | Also, when searching for the change control solution |
| Most companies simply want to save their hard | | | | that will fit the needs of a life science company, |
| earned ROI, but when considered carefully it's easy to | | | | professionals should look for a solution that is |
| see that manual and/or hybrid solutions won't save | | | | 1) customizable to their needs and that |
| companies money in the long run, and in addition, | | | | 2) require form explanations for changes that are |
| present a variety of problems that might have | | | | being made. Accountability, after all should be an |
| managed to stump even Solomon the wise. | | | | important aspect of change control. |
| Manual and Hybrid Solutions: Problems that Contribute | | | | A Picnic in the Park |
| to Greater Problems | | | | Change control can take life science professionals one |
| Listed below are some of the problems that life | | | | step further to a change management process that |
| science companies can avoid with a digitized and | | | | could potentially be compared to a picnic in the park. |
| centralized change control software solution. | | | | |