Web Document Management For the Pharmaceutical Industry - 7 Features and Benefits Worth Paying For

With the FDA's Critical Path Initiative paving a new road for various industries in the life sciences sector and the 21 CFR Part 11 regulation implicitly recommending the automation of quality and compliance process management in pharmaceutical environments, change is on the horizon for the burgeoning pharmaceutical sector.

Automation in the Pharmaceutical Sector

If your company, like other pharmaceutical companies, is considering the automation of GxP process, quality management, quality audit, compliance and document control processes, consider the following benefits that increased automation in the pharmaceutical sector should provide:

1. An increased ability for participants to virtually communicate regarding process information, documentation, etc.;
2. Full or partial elimination of redundant and iterate administrative tasks often associated with excessive man hours and spare amounts of actual production or achievement (i.e. using manual process to manage documentation essential to the approval and future of billion dollar drug compounds);
3. A more effective unification of quality departments with all other area departments (purchasing, manufacturing, etc.) in terms of understanding and real-time information. In other words, pharmaceutical professionals need to know how the processes they adhere to affect other processes throughout the company.

Achieving Automation Goals

To achieve automation goals, most pharmaceutical companies would do well to start by investing in a web document management solution that can be launched from the same platform as other solutions designed for the life science industries (i.e. GxP process control, quality management and quality audit solutions). The web document management software should also provide the following features and benefits:

#1: A History of Successful Validation

Quality assurance professionals and other pharmaceutical professionals know the importance of reputable software validation. When searching for a web document management solution, pharmaceutical professionals should pay close attention to its validation history.

#2: Speed

Let's get real. The only reason any pharmaceutical company would even consider the purchase of a web document management solution would be to save money and time on the product-to-market pathway. If any given solution does not automate and increase the speed of document change processes, document approvals, notifications and document distribution, then the solution isn't worth consideration.

#3: Time Required for Installation, Implementation and Validation-Affects on ROI

Some software vendors may tout the strengths of their software and its immediate capacity for providing a healthy ROI. However, they may conveniently fail to mention that their installation, implementation and validation processes may stretch into 6 months, a year or even longer. Pharmaceutical professionals need to search for a web document management solution that provides a healthy ROI but that makes a clear statement regarding the time that will be required for installation, implementation and validation. A clear statement will allow pharmaceutical companies to make transparent decisions and effective planning for the upcoming transitions that are inevitably linked with the switch to automated document control.

#4: Configurable and "Off-the-Shelf"

If pharmaceutical companies prefer an off-the-shelf web document management solution, it must still be configurable to the unique needs of every company that purchases it. Some pharmaceutical companies for instance may not apply the same steps throughout a routing or collaboration process and the web document management solution should be able to reflect that.

#5: Tracking and Audit Trails

The web document management solution should also provide tracking and audit-trail features as well as sophisticated revision controls and reporting features.

#6: Electronic Signature Controls

To comply with 21 CFR Part 11, pharmaceutical companies must employ electronic signature controls. A web document management software solution that automates document signings routing and collaboration is highly recommended.

#7: Compatibility with Other Existing Solutions

As mentioned earlier the web document management solution should be launched from a platform that will allow for the future launch of other solutions. These solutions may include GxP process solutions such as software for deviations identification, nonconformance identification, quality audit, customer complaint handling, change control and CAPA solutions. A submissions management solution particular to the pharmaceutical industry is also highly recommended.

Conclusion

Pharmaceutical companies are in a period of great opportunity and should be implementing less administrative man power and more time into research and development. The right software solutions can allow pharmaceutical companies a greater opportunity to do so.

Marci Crane is a copywriter for MasterControl in Salt Lake City. For more information in regard to web document management solutions, please feel free to contact a MasterControl representative