Where attendees learned about the best practices in the selection and implementation of Enterprise wide Doc Control System from market, so for global businesses such as pharmaceuticals, clinical research organization and life science organization with multiple brands, and with revenues of over $10B each, they seek for regulatory compliance as a prerequisite to achieve business needs for all quality processes, Document control and training segment. This depicts a true representation of an excellent quality deployment across the organization.
Many organizations experience they have situations that include enormous systems with multiple plants using ambiguous electronic document resulting in a mixture of manual paper-based processes and spreadsheets in a clumsy and uneven manner. In addition to its being credibly inefficient, it also lacks in transparency and traceability. Also, there were huge hidden IT costs and output remained very unreliable and error prone when reporting was rolled up. Huge amounts of time were consumed on the manual and human intervention activities associated with record management. We will focus on key points that supports the selection of the “best fit” Doc Control solution and delivered exceptional results upon deployment:
- Team Formation for Selection & Implementation
- Involvement of Stakeholder
- Scope of evaluation of vendors & software
- Planning for Implementation strategy
- Software monitoring and enhancement
- Robustness value
Team Formation for Selection & Implementation
One core requirement for success with Doc Control team that is capable, passionate and versatile. Organization’s built team must be engaged early and consistently throughout the initial selection to go live. The formation of the team should include regional and overseas business unit representatives and should be cross-functional with the appropriate subject matter expertise. A Doc Control will focus multiple prime of integration technology, many of which we learned can provide huge benefits for the deployment when done correctly. The team should include individuals with understanding of current or planned ERP, eQMS and LIMS platforms.
Involvement of Stakeholder
For easy going and achieving software project deployment milestone within appropriate timeline to generate requirement, involvement of and consultation of stakeholders from R&D, engineering, manufacturing, finance QA and QC provides the foundation for clear requirements avoiding the temptation to gather requirements too quickly from a limited group and perform a quick pass for validation is important to achieving buy-in when rolling out, but also provides a clear depiction of specific current pain points. This involvement will provide better vision when designing scripts & deliverable for vendors to establish their capabilities in the context of your organization’s demands.
Scope of evaluation of vendors & software
The best practices required for fulfilling objective is that efficient evaluation should be drawn within adequate time and resource allocated for project. The original request for proposal and its design has multiple functions, Keys document are providing, responses to requirements, license structure, implementation, project management, and support that ensure cross-vendor comparisons can be made. Evaluations of all demonstrations should be captured as best practice in a common platform for better communication. The vendor should be constrained to demonstrate requirements in the context of the buyer’s identified needs. It is still important to allocate appropriate time for the vendor to differentiate and demonstrate specific requirements.
Planning for Implementation strategy
Organizations can select Implementation planning was directed in parallel with performance testing of software. Upon validation of performance and availability the decision was made according client policies to achieve milestone in a phased approach. Training was delivered in train-the-trainer approach and key personnel on the original team were equipped with the necessary skills to represent the organization. The approach taken across either overseas sites or multi-site organization was for individual plants to determine their own timeline for implementation. This model meant that readiness could be established, and facilities could minimize interruption.
Software monitoring and enhancement
One significant point of learning for this session was the fact that the deployment is and will continue to be (just like cGMP) subject to continuous improvement. Configuration changes, reporting, and analytical approaches as well as many other sides will change with underlying processes as will the core solution. Identifying optimistic changes in the software can often be affected by the organization and, where required, changes submitted to the vendor for enclosure in new releases to align with current regulatory demands. The journey is one that will continue for the life of the solution Doc Control data serves automates.
The positive outcome of implementing Doc Control is often overlooked by regulatory drug manufacturer and Not all stakeholders are exposed to the benefits of the solution brings. Over and above a user’s common interactions with the integrated solution, it is crucial to share successes in terms of quality business benefits and advantages seen in the management of product compliance and transparency across organization. By seamlessly interfacing with the ERP, LIMS solution, Doc Control allowed robust tracking business processes for management.
As said above diagram our robust and powerful solution QEdge for whole eQMS activities (Quality Processes, Doc Control and Training management) throughout involved employees and organization constitute the most important resource for improving quality and data readily available for regulatory audits.