RCM specializes in providing innovative options to pharmaceutical, medical device and biotechnology companies in need of guidance, support or remediation of quality, compliance or business challenges.
Our proven team of subject matter experts recognizes that each RCM customer faces unique challenges in a regulated environment. Through the SME leadership, RCM’ solutions are consistently flexible, scalable and customizable.
With the most comprehensive network of proven consultants in the market, RCM is uniquely prepared to assist you with your staffing, solution, planning and remediation needs in the following areas:
RCM’s proprietary screening methodologies coupled with a consultant focused retention and utilization model has earned us the role as a trusted advisor and partner in execution for the industry’s most innovative companies in the following areas:
Their breadth of industry experiences range from utility, BMS/BAS, batch and continuous process control, sterilization, and packaging.
RCM can provide commissioning & qualification documents that verify proper installation, operation at start-up, functional performance, and turnover of facilities, systems and equipment.
After 40 years of doing business, our personnel have the expertise to work with you on projects of all sizes.
It could be a complete validation of a large construction project, a new facilities start-up, a full-scale commercial production campaign, an Installation and Operational Qualification of a single piece of equipment, or a validation of a new process within an existing facility.
RCM can provide expert staffing to give you the resources you need to get the project done right, on time, and on budget.
Internal or external systems suppliers (IT Organizations) in the Life Sciences industry must be governed by SDLC-centered and Compliance-focused Quality Management Systems. According to GAMP5, the expected QMS should define:
The QMS should include formal procedures covering the activities that support systems and software development, systems release, change control, configuration management, data backup and restore, personnel qualification, documentation management, etc. The QMS components may be unique to the IT organization or shared with the predominant company-wide QMS.
RCM offers its expertise in all aspects of IT-focused QMS and Quality Assurance, including, but not limited to:
Our current and potential clients who are looking to grow or improve their regulatory compliance commitments, are often in need of learning and understanding about the numerous areas addressed by the RCM core capabilities. Although some information can be found on the Internet or through pre-recorded training sessions, the clients are often left underwhelmed by these generalized options, with their particular questions still unanswered and their funds expended to gain a questionable value.