RCM Technologies helped a medical device client implement an electronic medical device reporting (eMDR) system within their existing TrackWise quality management system (QMS). This involved upgrading complaint forms to comply with eMDR standards, configuring TrackWise to allow for electronic submission to the FDA, and validating the new system. The project was completed on time and on budget, reducing costs associated with medical device reporting and ensuring all reports were submitted in compliance with regulations.

1. L if e S cienc e S olutions
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 and
Compliance Solutions Life Science Service Offerings
The US Food and Drug Administration Validation Solutions Implementation Solutions
(FDA) requires that life science organizations
• Audits (Quality, Vendor) • Data Migration
provide documented evidence that their
processes, their computer systems, their
• BMS (Andover, Honeywell, Johnson • HR / Payroll (ADP, PeopleSoft,
Control) Workday)
facilities, equipment and methods meet
quality requirements. RCM assists • EDMS (Documentum, LiveLink, • MicroSoft Applications
organizations achieve this evidence through QUMAS) (EPM, SharePoint)
our proprietary validation methodology • ERP (Oracle, SAP, Siemens) • Oracle EBS, PeopleSoft,
and processes. From design, startup, • Facilities Database Support
production, maintenance to decommis- • SAP
• Laboratory Instruments /
sioning, our techniques, guidance and Software • QMS (Vendor Selection,
qualified staff lead clients through the Implementation, Validation,
• LIMS (LabWare, LabVantage,
complexity of today’s regulations and Training, etc.)
Thermo Scientific)
interpretations. Validation encompasses
SOP’s, documentation, training, testing, • MES (Werum)
auditing and regulatory compliance. • Network Infrastructure Ways to Engage
• Process • Deliverable-Based / Milestone
RCM has a broad spectrum of services
addressing the complex regulatory issues • QMS (ETQ, MasterControl, Pilgrim, • Fixed-Price
including GxPs, CFRs (21 CFR Part 11) as TrackWise) • Risk-Reward
well as country-specific (outside the US) • Workflow Management • Staff Augmentation
compliance (GAMP 4/5).
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.
(973) 658.3176 I lifescience@rcmt.com www.rcmt.com/lifesciences

2. Quality Management System
Workflows, tracking and reporting.
L if e S cienc e S olutions
While every company needs to be concerned about quality, nowhere is it more
important than in pharmaceuticals, medical devices, biotechnologies, CROs and other
highly regulated industries. These companies not only abide by strict internal quality
management standards, but they must also comply with a myriad of rules mandated by
regulatory agencies. By centralizing workflow management, consolidating tracking and
streamlining regulatory reporting, companies are strategically positioned to identify and
manage quality compliance issues across critical business processes.
What is a Quality Management System?
While quality itself is evident in the product you produce, what defines it from a tracking and trending perspective can be subjective. Most
would agree that at the core of every quality system – and every quality program – is Documentation and Documentation Management.
Additionally, CAPA, Deviations/Non-Conformances, Investigation, Audits, Complaints, as well as related processes, are also incorporated.
What companies choose to put in their quality management system is as varied as the number of vendors that provide the capabilities.
Why do you need a Quality Management System?
The U.S. FDA, the European Medicines Agency (EMEA) and regulatory bodies worldwide expect life science organizations to
eliminate fragmented data silos and create a continuous, documented process for managing research, development, distribution
and post-market events. Implementing an integrated quality management system not only meets regulatory expectations, it also
provides a structured framework that proactively monitors global compliance, reduces risk and lowers the total cost of quality.
Quality Processes
Quality Processes Integration
Integration
Quality Management
• CAPA
• CAPA
• Data Entry Systems
• Data Entry Systems Expertise
• Change Control
• Change Control • ERP
• ERP
• Complaints
• Complaints • MES • Needs Assessment
• Deviations • MES
• Deviations
• Vendor Selection (RFI/RFP)
QMS • Implementation / Configuration
Document Management Training Management • Validation
• Material Masters • Curriculum Management • Training
• SOP • Employee Training
• Deviations
• Requirement Scheduling Contact RCM for more information.
(973) 658.3176 I lifescience@rcmt.com www.rcmt.com/lifesciences

3. Quality Management System
Case report.
L if e S cienc e S olutions
Medical Device Company
QMS/eMDR
Business Challenge
The client, a medical device company, decided to implement
Electronic Medical Device Reports (eMDR). Since the client was
already using TrackWise for their existing complaints project, it
was decided to also implement eMDR with the TrackWise tool. In Value Delivered
order to get to that point, their complaints forms had to be upgraded
Project Results: This project was completed on time and on budget.
to adhere to certain guidelines set forth in the eMDR standard. The By implementing eMDR within the TrackWise environment, the
TrackWise system then had to be linked to the client’s EDI tool for client was able to significantly reduce the time and subsequent
electronic submission to the FDA. costs associated with submitting eMDR reports. This effort ensured
that no eMDR reports were overlooked and significantly reduced
RCM was charged with identifying the gaps from the Current
underreporting by automating the reporting process through rules
Complaints and MedWatch process the client had in TrackWise. within the system.
This involved adhering to the eMDR standard as far as field types,
More efficient use of time and resources: By hiring RCM as its
implementing and validating those changes in the client’s system.
services partner, the client’s IT resources, scientists, business analysts
In addition, the submission and FDA acknowledgements had to be and compliance specialists were able to remain focused on the myriad
built into the existing workflow for the MedWatch records in of tasks that the business required.
TrackWise. This ensured that all information was captured in the
Effective knowledge transfer to client: By working in a team
system.
environment, document walkthroughs, regular status meetings and
timely presentations on data and results.
Requirements Approach
• Define the boundaries and constraints Solution
• Install the eMDR tool in the development environment The client selected RCM because of its life science compliance and
validation expertise. RCM provided a favorable rate by quoting a
• Identify gaps in the workflows, forms and fields based on a
fixed-price, deliverable-based estimate (versus ambiguous time and
preliminary map with the eMDR tool
materials proposals). RCM’s resources - with years of QMS experience
• Configure and validate changes in the gap assessment - implemented eMDR accurately, on time and under budget.
• Identify and assist with steps necessary to communicate with
the FDA gateway for eMDR submissions
The RCM Difference
• Utilize three (3) prototypes to streamline rollout during which
As a business trying to navigate today’s changing economy, RCM
validation preparation and planning will take place
understands our client’s need to respond to industry demands and make their
• The system evolves into production upon completion of organization more profitable by reducing expenses, maximizing revenues,
validation and approval increasing overall customer satisfaction, streamlining processes and gaining
competitive differentiation. RCM’s solutions have been proven to help clients
achieve and exceed these goals.
(973) 658.3176 I lifescience@rcmt.com www.rcmt.com/lifesciences