| With the FDA's Critical Path Initiative paving a new | | | | approvals, notifications and document distribution, then |
| road for various industries in the life sciences sector | | | | the solution isn't worth consideration. |
| and the 21 CFR Part 11 regulation implicitly | | | | #3: Time Required for Installation, Implementation and |
| recommending the automation of quality and | | | | Validation-Affects on ROI |
| compliance process management in pharmaceutical | | | | Some software vendors may tout the strengths of |
| environments, change is on the horizon for the | | | | their software and its immediate capacity for providing |
| burgeoning pharmaceutical sector. | | | | a healthy ROI. However, they may conveniently fail to |
| Automation in the Pharmaceutical Sector | | | | mention that their installation, implementation and |
| If your company, like other pharmaceutical companies, | | | | validation processes may stretch into 6 months, a year |
| is considering the automation of GxP process, quality | | | | or even longer. Pharmaceutical professionals need to |
| management, quality audit, compliance and document | | | | search for a web document management solution that |
| control processes, consider the following benefits that | | | | provides a healthy ROI but that makes a clear |
| increased automation in the pharmaceutical sector | | | | statement regarding the time that will be required for |
| should provide: | | | | installation, implementation and validation. A clear |
| | | | statement will allow pharmaceutical companies to |
| 1. An increased ability for participants to virtually | | | | make transparent decisions and effective planning for |
| communicate regarding process information, | | | | the upcoming transitions that are inevitably linked with |
| documentation, etc.; | | | | the switch to automated document control. |
| 2. Full or partial elimination of redundant and iterate | | | | #4: Configurable and "Off-the-Shelf" |
| administrative tasks often associated with excessive | | | | If pharmaceutical companies prefer an off-the-shelf |
| man hours and spare amounts of actual production or | | | | web document management solution, it must still be |
| achievement (i.e. using manual process to manage | | | | configurable to the unique needs of every company |
| documentation essential to the approval and future of | | | | that purchases it. Some pharmaceutical companies for |
| billion dollar drug compounds); | | | | instance may not apply the same steps throughout a |
| 3. A more effective unification of quality departments | | | | routing or collaboration process and the web |
| with all other area departments (purchasing, | | | | document management solution should be able to |
| manufacturing, etc.) in terms of understanding and | | | | reflect that. |
| real-time information. In other words, pharmaceutical | | | | #5: Tracking and Audit Trails |
| professionals need to know how the processes they | | | | The web document management solution should also |
| adhere to affect other processes throughout the | | | | provide tracking and audit-trail features as well as |
| company. | | | | sophisticated revision controls and reporting features. |
| Achieving Automation Goals | | | | #6: Electronic Signature Controls |
| To achieve automation goals, most pharmaceutical | | | | To comply with 21 CFR Part 11, pharmaceutical |
| companies would do well to start by investing in a web | | | | companies must employ electronic signature controls. |
| document management solution that can be launched | | | | A web document management software solution that |
| from the same platform as other solutions designed | | | | automates document signings routing and collaboration |
| for the life science industries (i.e. GxP process control, | | | | is highly recommended. |
| quality management and quality audit solutions). The | | | | #7: Compatibility with Other Existing Solutions |
| web document management software should also | | | | As mentioned earlier the web document management |
| provide the following features and benefits: | | | | solution should be launched from a platform that will |
| #1: A History of Successful Validation | | | | allow for the future launch of other solutions. These |
| Quality assurance professionals and other | | | | solutions may include GxP process solutions such as |
| pharmaceutical professionals know the importance of | | | | software for deviations identification, nonconformance |
| reputable software validation. When searching for a | | | | identification, quality audit, customer complaint handling, |
| web document management solution, pharmaceutical | | | | change control and CAPA solutions. A submissions |
| professionals should pay close attention to its validation | | | | management solution particular to the pharmaceutical |
| history. | | | | industry is also highly recommended. |
| #2: Speed | | | | Conclusion |
| Let's get real. The only reason any pharmaceutical | | | | Pharmaceutical companies are in a period of great |
| company would even consider the purchase of a web | | | | opportunity and should be implementing less |
| document management solution would be to save | | | | administrative man power and more time into research |
| money and time on the product-to-market pathway. If | | | | and development. The right software solutions can |
| any given solution does not automate and increase the | | | | allow pharmaceutical companies a greater opportunity |
| speed of document change processes, document | | | | to do so. |