| There is no way to circumvent two important facts: | | | | management. It is in the loss of final version |
| | | | documents or in the process of mistakenly revising |
| 1. Web document management software can save | | | | old versions of a document that medical device |
| medical device companies significant amounts of time | | | | companies waste a significant amount of time. |
| (hundreds or even thousands of annual hours); | | | | Medical device companies should search for a web |
| 2. Web document management software can provide | | | | document management solution with sophisticated |
| a healthy and relatively fast ROI for medical device | | | | document version control and serious security |
| companies. | | | | features. |
| To most medical device professionals, these facts | | | | #5: In-House Validation |
| may be as obvious as the sun at 12:00pm, but | | | | Okay, so validation isn't exactly a benefit of web |
| perhaps even these professionals may have failed to | | | | document management software (it's actually a |
| consider up close the multitude of hassles that can | | | | tedious pain) but if medical device professionals |
| be avoided with web document management | | | | search for the right software solution, some |
| software. | | | | software vendors actually provide validation scripts, |
| 8 Hassles that Can be Avoided with Web Document | | | | services and validation consultation which means |
| Management in Medical Device Environments | | | | in-house validation can be avoided altogether. |
| #1: Downtime | | | | #6: Learning Curves |
| Although "downtime" can be pleasant time, it's never | | | | Learning how to use a variety of various process |
| a good experience spending an entire afternoon | | | | management, CAPA, quality audit, or document |
| looking for the latest version of an SOP that was | | | | control solutions in one working environment can |
| supposed to be signed and sent to the QA | | | | become confusing. Medical device professionals should |
| department three weeks ago. | | | | search for solutions that can be launched from a |
| #2: Disconnects with Training Procedures | | | | single platform. |
| What happens when an SOP or a protocol manual is | | | | #7: Approval Paperwork |
| significantly edited? Are the changes always | | | | What's more tedious that the prospect of signing off |
| effectively communicated to all affected employees? | | | | on a stack of paperwork? Medical device |
| Many times necessary SOP and other document | | | | professionals should search for a web document |
| related training simply doesn't happen which results in | | | | management solution that allows signoffs to occur |
| plenty of headaches, back tracking and more wasted | | | | electronically upon the receipt of a notification |
| revenue. Medical device professionals should search | | | | delivered via email. |
| for a web document management solution that | | | | #8: Change Tracking Woes |
| automatically triggers a change control process when | | | | It's common for medical device professionals to |
| essential documents are edited. | | | | spend too much time trying to decide what |
| #3: Walking | | | | document changes were made, when they were |
| Walking can be an enjoyable activity but when | | | | made and by whom. Medical device professionals can |
| medical device employees are walking form office to | | | | avoid change tracking woes by investing in a web |
| office routing SOPs and trying to collaborate on | | | | document management solution that tracks |
| essential documentation hundreds (if not thousands) | | | | documents and all document versions from start to |
| of hours are wasted. After all, a medical device | | | | finish. |
| marketing application submitted one year (or even 6 | | | | Conclusion |
| months) earlier or later than planned can result if very | | | | For medical device companies, investing in a web |
| significant profits or very significant losses. | | | | document management solution create a series of |
| #4: Document Version Mishaps | | | | benefits which are felt throughout the entire |
| Automated document version control is sufficient | | | | company. |
| reason for an investment in web document | | | | |