| Life science companies have their goals of | | | | processes. |
| developing, manufacturing, and selling biotech | | | | The FDA requires that all processes (including |
| equipment, medical devices, drugs, and other | | | | change processes) are fully validated. Taking care |
| products that will increase their revenue. The | | | | of this requirement manually can be very |
| FDA, on the other hand, has the express goal of | | | | challenging. Electronic validation, though, is an |
| making sure these companies are working safely, | | | | effective way to make sure you are meeting |
| being transparent in their communication of | | | | those regulations automatically and efficiently. |
| possible dangers and side effects, and ensuring | | | | Paper-based systems are hard to maintain in an |
| the viable effectiveness of those products. | | | | effective way because it is hard to keep all the |
| Theoretically, these goals should support each | | | | necessary documents in the right place. Change |
| other, but in practice they are closer to being | | | | management software, though, was designed to |
| mutually exclusive. | | | | centralize that data so anyone that needs it can |
| With two seemingly opposing problems, the best | | | | easily access it at any time. High quality change |
| solution in the life science industry has to include | | | | management software should be able to control |
| change management software. These valuable | | | | the files required throughout any of the GxP |
| applications will allow you to deal with all the | | | | processes. |
| changes that can come up in the development | | | | Changes will happen no matter what you do, and |
| and manufacturing process. | | | | manually revising the documents to keep up will |
| Life science companies can face a lot of | | | | be hard. Employees will have to search through |
| problems, including trying to deal with the change | | | | huge amounts of documents and make the |
| management processes manually or by using a | | | | necessary changes to those documents or the |
| hybrid or decentralized solution. If you are really | | | | SOPs. Change management software will |
| interested in increasing your ROI, these methods | | | | automate and centralize the whole process and |
| may not be very helpful. | | | | make it easy to submit documents and get them |
| Companies often believe they can save a lot of | | | | approved. |
| money with paper-based systems, but that's not | | | | If you are in the market for change management |
| always true. The amount of time that has to be | | | | software that will fit your needs, be sure to find |
| spent on routing documents, getting approvals, | | | | the one that is customizable and will require form |
| and searching and retrieving documents can cost | | | | explanations for the changes that are being made. |
| a lot of money. Change management software, | | | | Accountability can't be ignored in this process, and |
| though, can automatically take care of the | | | | if you do it right, you will be able to take your |
| searching, retrieving, routing, and approval | | | | company to the next level. |