1. Life Science Solutions
Validation and
Compliance Solutions
The US Food and Drug Administration
(FDA) requires that life science organizations
provide documented evidence that their
processes, their computer systems, their
facilities, equipment and methods meet
quality requirements. RCM assists
organizations achieve this evidence through
our proprietary validation methodology
and processes. From design, startup,
production, maintenance to decommis-
sioning, our techniques, guidance and
qualified staff lead clients through the
complexity of today’s regulations and
interpretations. Validation encompasses
SOP’s, documentation, training, testing,
auditing and regulatory compliance.
RCM has a broad spectrum of services
addressing the complex regulatory issues
including GxPs, CFRs (21 CFR Part 11) as
well as country-specific (outside the US)
compliance (GAMP 4/5).
Driven by the need to address critical issues within a rapidly growing sector, the life sciences industry is focused on
leveraging its IT systems to significantly improve and expand its resources. RCM Technologies is a recognized global leader
in regulatory compliance services providing a broad range of consulting and management services to pharmaceutical,
biotechnology, medical device manufacturers, CRO’s and CMO’s.
Validation Solutions
• Audits (Quality, Vendor)
• BMS (Andover, Honeywell, Johnson
Control)
• EDMS (Documentum, LiveLink,
QUMAS)
• ERP (Oracle, SAP, Siemens)
• Facilities
• Laboratory Instruments /
Software
• LIMS (LabWare, LabVantage,
Thermo Scientific)
• MES (Werum)
• Network Infrastructure
• Process
• QMS (ETQ, MasterControl, Pilgrim,
TrackWise)
• Workflow Management
Implementation Solutions
• Data Migration
• HR / Payroll (ADP, PeopleSoft,
Workday)
• Microsoft Applications
(EPM, SharePoint)
• Oracle EBS, PeopleSoft,
Database Support
• SAP
• QMS (Vendor Selection,
Implementation, Validation,
Training, etc.)
Ways to Engage
• Deliverable-Based / Milestone
• Fixed-Price
• Risk-Reward
• Staff Augmentation
RCM supports its clients’ regulatory compliance efforts with comprehensive expertise in Part 11, pharmacovigilance, computer systems
validation and qualification, lab equipment and process validation as well as enterprise application software implementation.
Find out how RCM can help you today.
Life Science Service Offerings
(973) 309-0280 • james.beacham@rcmt.com www.rcmt.com/lifesciences