Validation Department Support
The validation department plays a critical role in assuring the prosperity of your organization and safety of its patients. This task is not easily done, as the difficulty in assuring validation work is completed in a compliant and audit ready fashion is highly dependent upon your overall project team. Teams with limited quality knowledge require more validation management. Additionally, regulatory audits or spikes in project volume can have a devastating impact on the productivity of your company, leading to increased costs for all project teams as they wait for the Validation department to catch up.
Sequence understands the unique demands of the Validation Department because we have been supporting them since our company was founded in 2002.
What value does Sequence deliver to your Validation department?
From project dedicated roles to oversight roles, we offer consulting options to meet your validation needs. Experienced and knowledgeable Sequence consultants take responsibility for your projects and their success. Our ‘Partner’ perspective towards each customer gives you much more than staff simply looking to complete a task, it gives you responsible consultants dedicated to delivering your project compliantly and efficiently.
If you would like to spend less time supervising your project consultants and would like to more easily manage fluctuations in your work load, Sequence can help.
Services can be provided by project team, individualized support, or managed service.
Sequence consultants deliver the following services with a full understanding of the system Development Lifecycle, executed as required for your needs.
Any GxP Equipment: Laboratory, Packaging, Production, Utilities
Any local or distributed GxP automation system: SCADA, BAS, PAS, PLC, DCS
Information System Qualification
From Client to Enterprise applications:
SAP, LIMS, PI, Management systems (Document, Change, calibration, Inventory, maintenance)
Compound, Mix, Blend, Granulate, upstream, downstream, Cleaning
Process development and Qualification.
Assuring analytical methods have the required accuracy and precision
Quality Management Systems, Change Control, Monitoring, Calibration.