Life Science Services

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:

  • Automation
  • Commissioning and Qualification (Equipment, Facilities and Utilities)
  • Compliance and Quality (21 CFR Part 11 and other FDA Compliance)
  • Health Authorities Observations Response and Remediation (483, Warning Letters, Consent Decrees)
  • Validation and Verification (Cleaning, CSV and Process)
  • QA and Quality Management Systems
  • Training and Coaching​ ​

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:

  • Staffing and full-time placement
  • Project oversight and planning
  • Assessments and Audits
  • Centers of Excellence
  • Implementation and Change Control

RCM offers personnel who deliver specialty automation services for the Life Science industry, including facility integration services from system evaluation and determination to installation and integration.

Their breadth of industry experiences range from utility, BMS/BAS, batch and continuous process control, sterilization, and packaging.

  • Control System Integration
  • PLC/DC/HMI Programing
  • Full Lifecycle Documentation Development & Execution
  • Experience with:
    • Allen-Bradley / Rockwell
    • Delta V
    • Honeywell
    • Johnson Controls
    • Siemens​
​At RCM, it’s our goal to help our clients ensure their facility, utilities and equipment perform as intended. We do that through commissioning and qualification services, using a risk-based approach (i.e. ASTM E2500) to reduce the extent of systems needing qualification and the implementation and lifecycle cost.

​RCM can provide commissioning & qualification documents that verify proper installation, operation at start-up, functional performance, and turnover of facilities, systems and equipment.

RCM will work with you to set the direction, lay out the plan, and execute the plan,  saving you time and money, as you optimize your Quality / Compliance programs by offering the following value-added services:

Compliance Services:

  • Due Diligence Compliance Inspections, Audits & Assistance
  • FDA Action (483 Observations, Warning Letters, Consent Decrees, Remediation)
  • Mock FDA/International Regulatory Agency Inspections & PAI Readiness
  • Post Audit Remediation
  • Regulatory Compliance Assessments (FDA, EMEA, MHRA, DEA, ANVISA, COFEPRIS, Health Canada)
  • Third-party GMP & GLP Compliance Auditing
Quality Assurance:

  • Policy, SOP & Batch Record Review, Preparation & Optimization
  • QA Staff Augmentation
  • Quality System (QS) Development, Assessment & Optimization
  • Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution
Quality Control:

  • Analytical Methods Validation
  • Analytical Methods  Transfer
  • QC System Audit/Remediation
  • QC Staffing

​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.

Cleaning Validation
Our team members are knowledgeable in the latest cleaning techniques and technologies, as well as all current regulatory requirements and industry trends across various regulated manufacturing industries.

Computer System Validation 

  • Calibration Management Systems (i.e. ProCal, RAM)
  • Custom (Bespoke) Systems
  • Data Historian Systems (OSI PI Systems)
  • DCS and PLC-based Building Automation/Management systems (i.e Siemens, JCI, Delta V)
  • EDMS Systems (i.e. Documentum, Workbench)
  • Laboratory Systems (i.e. Labware LIMS, Kaye LabWatch, Empower, Chemstation)
  • MRP/ERP Systems (SAP)
  • Quality Management Systems (Trackwise)
  • SaaS Platforms and Cloud Technology​
  • Training Systems (i.e. Active Learner)

Process Validation
At RCM, we are experienced in process/technology transfer, process optimization, scale up, and process validation. We can provide the expertise to develop your process validation strategy and manage execution of the validation process based on the new guidance given by the FDA (ICH Q8, Q9, & Q10).

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 process being followed in order to deliver and support the system
  • Responsibilities, including clear separation of authority between Quality Assurance and other groups
  • Deliverables and Documentation
  • Planned reviews of the QMS and internal audits, as a part of continuous improvement of QMS and its use.

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:

  •  Initial implementation of robust and harmonized QMS
  • Scalable “As-Needed” approach
  • QMS maintenance activities from periodic reviews to updates to ongoing training
  • QMS expansion due to organizational growth and changes
  • Periodic Audits/Assessments
  • Preparation and Training for Audits
  • Representation During Audits
  • Full Closure of Audit Findings

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.