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"With more than 30 years' history and as one of the first software vendors to
develop an
enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent,
international vendor of enterprise business solutions. "
Source : SYSPRO
Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
FDA Compliance is also known as :
FDA Approval,
FDA Approval Guidelines,
FDA Compliance,
FDA Compliance Consultants,
FDA Compliance Consulting,
FDA Compliance Guidance,
FDA Compliance Guide,
FDA Compliance Guidelines,
FDA Compliance Manual,
FDA Compliance Officer,
FDA Compliance Policy,
FDA Compliance Policy Guide,
FDA Compliance Program,
FDA Compliance Programs,
FDA Compliance Software,
FDA Compliance Testing,
FDA Compliant,
FDA Guideline,
FDA Guidelines,
FDA Label Compliance,
FDA Medical Device Compliance,
FDA Regulatory Compliance,
FDA Requirements,
Food and Drug Administration FDA,
Medical Regulatory Compliance,
Regulatory Compliance,
Regulatory Compliance Software,
FDA Policy,
FDA Compliance Consulting.
While every manufacturer in the United States is subject
to a multitude of governmental rules and regulations,
probably no industries are as fully regulated as those
dealing with pharmaceuticals and medical devices. The
U.S. FDA (Food and Drug Administration) requires
companies in these segments to comply with standards
for quality, safety, effectiveness, identity and strength.
Because the burden is on the manufacturers to prove
conformity, they are forced to employ costly, stringent
procedures, maintain in-depth documentation and
generate a myriad of substantiating reports.
Medical Device Manufacturers, similar to other
manufacturers, have long embraced ERP (Enterprise
Resource Planning) and CRM (Customer Relationship
Management) software systems. However, they have
primarily employed them to achieve operational
efficiencies as well as further sales and marketing
objectives. Indeed, today’s sophisticated ERP and CRM
systems support a broad set of activities that help
manage and coordinate business functions, including
production planning, purchasing, inventory maintenance,
supplier interaction, order tracking and customer service.
However, many Medical Device Manufacturers have also
discovered that their choice of ERP and CRM software
can play a significant role in their abilities to comply
with strict FDA regulations.
Basically, the FDA requires that each manufacturer
shall establish and maintain a quality system that is
appropriate for the specific medical device(s) designed
or manufactured. The quality system has to be an
integrated effort, i.e., a total systems approach to
satisfy the particular safety and performance needs
of a specific manufacturer, product and user-market.
The Quality Assurance activities have to extend
beyond inspection and testing spot solutions and must
cover all areas that have an effect on the quality, safety
and effectiveness of the device. These areas include
product development, design verification and
validation, component and/or supplier selection,
documentation, development of labeling, design
transfer, process development and validation, pilot
product, routine manufacturing, test/inspection, device
history record evaluation, distribution, service or repair
and complaints.
Not too surprisingly, most of the aforementioned
requirements can be satisfied through the judicious
selection and utilization of good ERP and CRM software.
In addition to enhanced operational efficiencies, a well
thought-out software choice can facilitate adherence
to required procedures and generate the necessary
backup reports.
Let’s take a look at selected ERP and CRM
functionalities and how they can serve to satisfy FDA
requirements.
Engineering Change Control
The Engineering Change Control process is a userdefinable
workflow type ERP sub-system. It can
augment or even replace the paper trail that usually
accompanies any changes to product design data.
By providing mechanisms, audit trails and archives,
Engineering Change Control functionality gives
Medical Device Manufacturers ready access to
documentation on prior product versions. In this
manner, the manufacturer has the ability to address
questions relating to product defects in older product
versions. Comprehensive ECC documentation also
enables manufacturers to easily revert to the
production of prior product versions, if necessary, to
suit the requirements of a particular customer or
conform to FDA requirements.
According to FDA’s publication in 21 CFR 820.40,
Medical Device Manufacturers are required to have
written procedures for the approval and distribution of
documents. The approval procedures must ensure that
the documents meet the requirements of the QS/GMP
as well as adequacy for their intended use. Obsolete
documents must be removed from circulation, and
document approvals must include a signature and date.
Removal (or prevention of use) of obsolete documents
must also be verified. Written procedures
(manufacturing, design, quality control, laboratory, etc.)
need to be signed and dated as approved.
When reviewing Device Master Record (DMR) and DHR
documents, manufacturers must assure that those in
use have been signed and dated as approved. All
documents prepared to comply with the QS/GMP must
be available at the point at which they are to be used
or otherwise needed.
Changes to all approved documents must be reviewed
and approved, communicated to appropriate personnel
in a timely manner and maintained. Document change
records must include a description of the change,
identification of the affected documents, an appropriate
approval signature, approval date and effective date of
the change. No changes are to be implemented prior
to approval. The approving official should be the same
person or from the same department as the original
approver. If not, there must be documentation that
specifically designates who is responsible for approving
the change.
Engineer Change Orders, typically the hub of an
Engineering Change Control system, can satisfy most
of these severe documentation requirements. The
Engineering Change Order (ECO) cycle is typically
governed by user-defined status codes. Each userdefined
status is associated with a system status that
enables the system to relate to the user-defined
statuses. Typically, the link between the user-defined
status and the system status is not a one-to-one
relationship, i.e., any number of user-defined statuses
can be associated with a single system status. For
example, while the system may only recognize the fact
that an ECO is in progress, users of the ECC system
can define a string of statuses through which an ECO
must pass during its in progress phases. This routing
of ECOs through user-defined statuses is achieved by
means of a status routing file in which all possible from/
to statuses are held.
Also, typically associated with user-defined statuses are
events. When an ECO is moved into a status, any
associated events are raised. Once an ECO has been
raised, the ECC user must identify all products affected
by the change, which is an FDA requirement. At least
one product must be specified before an ECO can be
moved from the system status of new to in progress.
A where-used query, which includes all routes identified
as being under ECC, is provided to aid the user in
identifying possible candidates. Also available on the
where-used query are lists of existing jobs, purchase
orders and sales orders relating to the products. These
can be placed on hold manually, if necessary.
When the ECO is moved from new to in progress,
the current revisions/releases of the Bills of Material
(BOMs) and routings for all products listed on the ECO
and for all routes flagged as being subject to ECC are
copied to separate tables. All maintenance of BOMs
and routings for ECC controlled products are performed
against these tables.
Advanced Planning and Scheduling
Advanced Planning and Scheduling (APS), often an
integral part of an ERP software solution, enables
manufacturing management to gain a real-time picture
of current shop floor activities. This capability allows
the manager to invoke last minute production adjustments
to make allowances for absentee workers, machine down
times and bottlenecks as well as to accommodate rush
orders. Typically, APS software provides the ability to
run a variety of reports that give managers better insight
into factory operations and further compliance with FDA
quality controls. These include manufacturing route
details, bills of material details, resource usage, cell and
work center details as well as specifics for each machine
on the factory floor.
Selected AP&S solutions also enable manufacturers to
define quality items relating to a machine, product and
customer. The data can be manually and/or
automatically collected and stored in a database, which
can then be queried directly or brought into an analysis
tool an essential for FDA compliance.
The Quality monitoring capability enables instant checks
for trends and blips in the collected data and can be
configured to send warnings to other users when
processes are going out of tolerance.
Inventory Tracking
According to FDA’s publication in 21 CFR 820.60,
manufacturers are required to have written procedures
for identifying products during all stages of receipt,
production, distribution and installation to prevent mixups.
However, not all ERP systems are equal when it
comes to the breadth and depth of inventory tracking.
Therefore, it is critical for Medical Device Manufacturers
to ascertain whether the inventory tracking module of
the chosen ERP solution provides the bells and whistles
necessary to facilitate FDA compliance. The ability of
the system to perform Lot and Serial Tracking is of vital
importance.
A Lot and Serial Tracking module forms a ‘secure file’ of
information gained from the entire manufacturing process
- from the testing of raw materials through to the
completion of finished goods. It is done by recording
material movement through receiving, manufacturing,
assembly, inspection, stocking and final dispatch. It
provides the ability to trace where a product originated
through to where it went with full upward and downward
traceability of all inventory transactions. Some of the
key features to look for are two-stage receiving, shelf
life control of stock, archives of history, bin/lot and serial
number cross-referencing and reject control/return
documentation. A practical feature is the ability to assign
lot numbers manually or automatically and that can be
either numeric or alphanumeric. The database of
information helps to ascertain compliance with FDA
quality regulations. The secure file must be fully
accessible and non-alterable.
The traceability requirement should not be confused with
the tracking regulation under FDA’s 21 CFR 821. The tracking
regulation requires certain devices to be tracked to the end
user or patient through the entire distribution process.
Components of a device subject to traceability
requirements must be identified with a control number
where appropriate. Therefore, in selecting an ERP
system, it is vital that any solution selected
accommodate large field lengths. Manufacturers must
define which components are to be identified with control
numbers and provide justification for those that are not
identified with control numbers.
Handling of Returns
The QS/GMP requires manufacturers to evaluate their
suppliers and to evaluate their quality data for problems.
One method of doing this is to record the percentage of
essential component rejects per lot, as well as the
percentage of lots rejected. If the manufacturer has the
raw accept/reject data in a form that can be evaluated to
determine supplier performance and is periodically doing
this evaluation, this would be acceptable in lieu of
recorded percentages.
RMA (Return Materials Authorization) and RTV (Return
to Vendor) ERP software system applications can play
a vital role in tracking returned or exchanged items sold
to customers or bought from suppliers. Typically, the
software automatically generates RMA/RTV tracking
documents noting the reasons for the return and/ or
exchange. The documents are linked with crossshipments,
inventory and credit control as well as
invoices and credit notes, providing many investigative
pathways. By defining and applying customized RMA
codes, trends can be ascertained and analyzed for
quality control purposes and FDA compliance. With a
click, manufacturers have the ability to see all customer
purchases for any specific model by purchase date.
According to FDA’s publication in 21 CFR 820.75,
manufacturers must make the determination as to
whether the firm’s processes are or may be contributing
to defective devices. There are several ways of making
this assessment, for example;
Process validation information should be reviewed to
identify defect characteristics and the rate of expected
defects of each characteristic for the finished product. If
the rate of defects is found to be exceeded during inprocess
or finished device acceptance, the process(es)
may be out-of-control or were not properly validated.
Also, the first and last article test results should be
reviewed for continuous processes such as extrusion or
injection molding, automated soldering, automated filling
lines, automated testing, etc., which may show test
failures of the last test article.
Business Analytics
Medical Device Manufacturers must be able to quickly
and easily access the information they need to make
decisions that impact quality and security. While many
organizations have deployed enterprise applications to
improve operational processes, these same
organizations fail to provide employees with the insight
needed to make quality related business decisions.
However, a business can use the data from existing
systems to create rich business performance information
that serves as a knowledge base for decisions that
impact FDA compliance. Business Analytics software
enables users to create multi-dimensional views of their
financial and operational data to determine patterns and
underlying trends, gauge performance and reveal new
pathways. Business Analytics often includes a series
of data mining cubes to produce dynamic, general and
enterprise specific metrics, ratios and analyses. An
administrator toolset will typically allow for the
manipulation of the cube(s) to accommodate
requirements, usually without any special On-line
Analytical Processing (OLAP) knowledge.
Report Writer
While the FDA requires the regular submission of
compliance reports, the organization can request special
reports. Therefore, it is essential that manufacturers of
medical devices have the ability to create these reports
with minimal effort. While all ERP systems offer report
generation, not all enable the easy generation of
customized reports. For the ready generation of these
reports, it is advisable that the ERP Report Writer module
have access to all files and fields within the database,
that reports are completely user-definable enabling the
retrieval of desired data in a preferred format and that
the reports can interface with an Office Automation
module for easy email disbursement.
Electronic Signatures
A fairly new requirement of FDA-regulated medical device
manufacturing companies concerns Section 21 Part 11
of the Code of Federal Regulations. The code
establishes the standards by which the Food and Drug
Administration will accept electronic records and
electronic signatures as equivalent to paper records and
handwritten signatures. The rule governs electronic
records throughout their lifecycle from creation through
modification, storage, and final transmission to the FDA.
The creation of this regulation and the FDA’s
encouragement of the use of electronic records and
signatures have placed a significant burden on the
developers and users of data collection,
management, reporting, and analysis software in
regulated industries .
Two important components of compliance are the
positive identification of the person creating or
modifying data records, and the use of audit trails for
the data and system parameters affecting its collection
and management.
FDA Requirements Single Point of Contact
The FDA requires that the customers of Medical Device
Manufacturers have a single point of contact for any
service or product recall related questions. A
knowledge base that includes technical documentation
is required to be easily accessed and up to date
according to standards set forth in the FDA’s
publication in 21 CFR 820.40. Here again, Medical
Device Manufacturers choosing ERP and CRM
software solutions must make sure they are totally
integrated and draw from a single database that is
updated in real time.
Unfortunately, most CRM products offer only batch
integration in which data entered into the CRM system
must be copied after-the-fact or offline into the ERP
system. This is a weakness of these systems and
precludes the assurance that users are always working
with the most current data. For FDA compliance, a
CRM system must offer real-time synchronization of
its database with the customer, vendor, inventory, order
entry, accounts receivable and accounts payable files
of integrated ERP systems.
The Correct Prescription
Not all ERP and CRM solutions offer the functionality to offer
compliance with the above requirements. But there are
integrated ERP/CRM packages that do, such as SYSPRO.
In essence Medical Device Manufacturers need to look
beyond usual ERP/CRM to more unique functionality, such
as: FDA regulated security; Shared document library with
audit trail for service and quality assurance; Change control
with audit trail traceability; Ability to view data as graphs,
with drill down analysis; Custom calculations to facilitate
complex analysis; and the ability to export data to
spreadsheets or text documents. Equally as important,
the software should offer product tracking by both serial and
lot numbers and perform service trends analysis to support
regulatory compliance reporting. Moreover, the software
should also maintain a knowledge base of technical and
clinical support issues and manage maintenance contracts
and product warranties. Today, there are many choices in
CRM technologies. Most offer strengths in traditional areas
such as sales and service, while others go beyond the
norm to offer a suitable prescription to remedy the noted
stringent requirements placed on the medical device
manufacturing industry by the FDA and other regulatory
bodies. In most cases, CRM software is designed to do
much more than help pass the FDA test. Aside from the
software’s ability to reduce the painstaking process of
generating complex reports, it can help improve market
penetration, promote clear communication with customers
and vendors, assist in maintaining quality control and, of
course, help retain customers by improving service,
responsiveness, company-wide knowledge and reliability.
Those contemplating CRM systems would be wise to look
for packages that aid in regulatory compliance and enhance
all aspects of customer relations.