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Biotechnology and Pharmaceutical Automation,
Commissioning and Validation Services
Validation. Automation. Implementation and commissioning. Integration. Collaboration. Vision.
For pharmaceutical and biotechnology managers seeking a production improvement partner that truly knows your business, RoviSys offers a full toolbox of proven automation resources, large-scale project management skills and a pragmatic get-it-done attitude difficult to duplicate elsewhere:
Experience: More than a decade engineering and implementing production automation projects of all sizes and types for leading pharmaceutical and biotechnology companies.
Comprehensiveness: Extensive and proven in-house controls, software development, information integration and validation resources—and the culture and systems to apply them quickly to any project as new needs arise.
Versatility: The proven ability to deliver value anywhere in your initiative, from problem-solving to concept to design to implementation, validation, commissioning, qualification and beyond.
Resources: One of the largest independent providers of automation services in North America, RoviSys is 130 people strong and growing.
Discipline: Early on, we understood that project management and communication are as critical as technical expertise. We developed the now commercially-available GrandView projects collaboration system to get you successfully from project objectives to real results.
Commitment: To being effective and efficient; to independence, placing your best interest above all others; to vision, to considering how today’s goals and efforts will impact the future.
With RoviSys on your team, you can go confidently from requirements to post-implementation audit. We make sure we understand the philosophies and objectives behind your specifications and how the current project fits into your overall needs, current systems and potential opportunities. And we back it up with world-class automation and integration capability, extensive validation experience and the proven ability to implement and support our work.
So what you want done gets done, while your possibilities remain open.
RoviSys validation and automation capabilities
To meet the need of biotechnology and pharmaceutical companies for advanced validated process automation systems and services, RoviSys provides the following according to Good Automated Manufacturing Practice (GAMP) and other relevant guidelines and regulations:
• Initiating and moving projects from validation requirement development all the way to validated and functioning production
• Collaborating with your corporate or outside compliance resources to engineer and implement the systems you need to achieve your objectives
• Performing the individual engineering, documentation or implementation work you specify.
Typical projects include design and documentation, implementation, validation, process description, functional requirements, specification, implementation and integration.
Advanced project collaboration
RoviSys brings you more than the powerful combination of automation expertise and validation experience. You also get secure around-the-clock access to the progress and details on all your projects with GrandView.
GrandView turbo charges you past conventional methods of project management, tracking and reporting, giving you a direct on-line link to our internal business management system. It is a comprehensive business, financial and project management software package that supports the daily operations of time reporting, purchasing, proposal writing, order entry and project tracking. Data is completely integrated so that you only need to enter it once to make it available throughout the system.
The key to a successful project is strong project management. For this reason, every project at RoviSys is assigned a project manager that keeps the project team focused on the schedule milestones. The RoviSys project manager will ensure the scope of work is fully understood between all parties and proper communication channels are established. For many projects, RoviSys will also utilize an on-site manager as a liaison to help expedite and clarify any required issues.
The specific responsibilities typically required of the project manager include but are not limited to the following:
- Management of project hours relative to task accomplishment and scheduled delivery
- Meeting documentation and minutes
- Technical guidance for the system specifications
- Technical guidance for the implementation of procedures
- Technical guidance for validation and validation documentation
- Technical guidance for system integration
- Project documentation and job notebooks
- Handling all customer interfaces, correspondence and billings
Beyond validation: integrating the new, overcoming the unexpected
Things change: new technology arrives, vendors come and go, requirements shift, unexpected obstacles pop up. Staying on track requires resources, systems and experience—qualities you put on your side with RoviSys. Not only do we routinely evaluate and implement new technologies in new ways, but systemically adjust and redeploy project resources as needed to meet your time, budget and capability needs.