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