Project Management
We provide senior project managers who can manage a variety of projects, from commissioning/ qualification, process and cleaning validation, PAT implementation, process improvement projects, compliance implementation and construction management. We provide resources with the technical skills and the project management experience and discipline to ensure your project's success. Our project managers deliver on time and on budget while meeting all compliance and business objectives.

Maintenance Program Development

We understand both the business drivers and the regulatory drivers for a good preventive maintenance and calibration program.
We can rapidly and economically assess your company's maintenance programs, focusing on critical areas such as calibration, personnel training, quality assurance, and overall cGMP compliance. Following the assessment, we can provide a detailed project plan with specific action steps to ensure reliable equipment operation, proper documentation of maintenance and streamlined procedures. We take an integrated approach to maintenance. Our in-depth understanding of quality assurance and validation allows us to incorporate these key functions directly into your program.
We understand reliability-centered maintenance as a strategy for formulating an optimum, cost-effective program that meets business and regulatory requirements.
We are familiar with CMMS systems and can help you select and/or implement a system that results in a successful and sustainable maintenance program.
 

SOPs and Training
Our technical staff is adept at developing technical procedures to support equipment operation, IT system administration, mechanical maintenance and instrument calibration. Our curriculum development experts can also provide training on these procedures and related topics.