| The life science environments are barraged with | | | | options and less success. Many life science |
| pressures: governmental regulations, | | | | companies could directly combat these backwards |
| recommended standards, and demands for higher | | | | trends by investing in ROI-efficient web document |
| quality and lower prices are nothing more than the | | | | management and quality audit technologies, which |
| dreaded Bermuda triangle of the pharmaceutical, | | | | would aid in the creation of streamlined web |
| medical device, biologics and blood/tissue | | | | document management for all quality processes |
| industries. | | | | and simultaneous audit process and report |
| Audits | | | | controls. |
| Audits (both performance and compliance related) | | | | Additional Benefits of Web Document |
| have long been tools for improvement in these | | | | Management |
| industries. However, audits whether conducted or | | | | Additional benefits of a web document |
| received at the 1st, 2nd or 3rd party levels can | | | | management can also include the following: |
| be a waste of time when the data is not quickly | | | | - Web-Based Functionalities |
| collected and presented---leaving senior | | | | - Electronic Routing |
| management officers to make decisions based on | | | | - Electronic Document Approval |
| month- or year-old data. | | | | - Electronic Signature Control |
| Audits are also a waste of time when | | | | - The Assurance of Compliance with 21 CFR Part |
| performance or compliance patterns within a | | | | 11 Regulations |
| company go unnoticed because auditors are | | | | - The Provision of a Validation Plan (IQ, OQ, PQ) |
| consumed with the gathering and input of | | | | - Open-Systems Architecture (Scalable) |
| superficial data, instead of the analysis and reports | | | | - Supportive of Industry-Standard Databases |
| based on deep and trended data. | | | | - Revision Control |
| These issues are real problems in the life science | | | | - Electronic Audit Trails |
| industry and must be addressed. So what is the | | | | - Sophisticated Security Features |
| real issue? The real issue is saving more time for | | | | - Analytics |
| auditors to analyze and present data with | | | | - Reporting |
| technology that automates the collection, input | | | | - Manages Various Document Types |
| and organization of the data itself. | | | | - Automated Escalation |
| Web Document Management and Audit | | | | - Dependent Routing |
| Technology | | | | - Potential Integration with Additional Web-Based |
| Web document management has long been a | | | | Applications |
| boon in the technical industries and implementation | | | | Where to Start? |
| within the life science industries is growing. | | | | Life science companies should start with the |
| However, many life science companies, including | | | | basics. Ask yourself where you want to benefit |
| large pharmaceutical and medical device | | | | and start searching for the software. Once you |
| companies continue to conduct audits or | | | | find an array of potential providers, ask them |
| "welcome" auditors with an arduous stack of hard | | | | how soon you will see a ROI after the |
| copy paperwork. Not only does the paperwork | | | | implementation of their products and don't forget |
| result in unavoidable efficiencies, it also acts as a | | | | to ask them how long of a time period |
| significant time retardant and leaves auditors and | | | | implementation will require! |
| senior management officers with less data, less | | | | |