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SOP Management as a
Compliance Tool in FDA and
ISO Environments
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SOP Management as a Compliance Tool
Introduction
From manufacturers to hospitals to the military, most organizations need standard operating procedures (SOPs) for
a variety of reasons. An SOP may be as simple as a description of how to sanitize milk pails in a dairy factory, or as
complex as the process of chemical isolation and purifcation of an active pharmaceutical ingredient in a chemical
manufacturing company.
An SOP describes a procedure and tells an operator how to perform it. SOPs are helpful in most workplace settings,
but they are especially critical for organizations with process-oriented operations, such as life sciences and other
manufacturing companies. SOPs, in conjunction with personnel training, help relay knowledge from one department to
another. In a medical device frm, for example, R&D scientists pass their knowledge about a product they innovated to the
manufacturing department through SOPs.
Manufacturers with global operations also rely on SOPs to standardize processes in all of their facilities. For example, a
Japanese automotive company will train its personnel in the United States on key manufacturing processes and then use
SOPs to make sure that high quality is refected in every car sold by the company regardless of where it was assembled.
There are many other reasons why organizations use SOPs, including:

To ensure consistent, repeatable processes;
To facilitate training by giving trainees a point of reference;
To facilitate cross-training of employees on tasks they dont normally perform, such as when they need to
substitute vacationing or sick co-workers.
To reduce safety risks and other hazards by specifying how to avoid and prevent them;
To have a basis for evaluation and improvement of processes; and
To comply with regulations and/or quality standards.

Regulations and Standards
The last reason compliance with regulations and quality standards is a key factor that drives many organizations to
establish and maintain SOPs. In FDA and ISO environments, the concept of quality is made tangible by the information
and processes captured in SOPs, and proper implementation of those SOPs helps ensure quality.
FDAs Current Good Manufacturing Practice (CGMP) regulations for fnished pharmaceuticals (21 CFR Parts 210-211)
require written procedures for production and process control to ensure that products have the identity, strength, quality,
and purity they purport to possess (Section 211.100). These written procedures, including any changes, must be reviewed
and approved by the quality control unit.
CGMP regulations for blood and blood components (21 CFR 606) state that written operating procedures shall be
maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage, and
distribution of blood and blood components for transfusion and further manufacturing purposes (Section 606.100b).
The Quality System Regulation (21 CFR Part 820) for medical devices similarly requires SOPs and documented
instructions that defne and control the manner of production (Section 820.70).
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SOP Management as a Compliance Tool
Manufacturers and other organizations that adhere to quality standards developed by the International Organization for
Standardization (ISO) face similar requirements.


MasterControls suite automates, and effectively integrates SOP management with change control, training control,
audits, corrective/preventive action (CAPA), and customer complaint processes, under a single Web-based platform.


ISO 9001:2008 and ISO 13485:2003, widely used throughout the world, require companies to document their procedures,
describe how those processes interact, and develop documents for implementation of the quality system. Compliance with
ISO standards is voluntary, although certain countries require ISO certifcation and many customers prefer vendors and
suppliers that are ISO-certifed.

Types of SOPs
SOP formats are as varied as business operations. An SOP may come in the form of a checklist, or a linear fow chart (or
some other type of fowchart), or hierarchical steps, or annotated photos.
Neither the FDA nor ISO require any specifc SOP formats. In general, however, SOPs in regulated environments are
expected to be consistent and traceable. They should provide document identifcation and facilitate control.
To be effective, an SOP should include company name, a descriptive SOP title, identifcation and control numbers,
purpose, scope, responsibilities involved (specifc tasks, whos performing what, certifcation and qualifcation
requirements, etc.), and step-by-step procedure. Depending on the nature of the process being described, the SOP may
include calculations for data handling.
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SOP Management as a Compliance Tool
SOPs are usually categorized by procedure type, such as design, manufacturing, quality assurance, etc. Categories help
determine the right format for each SOP and also facilitate appropriate review and approval for the document.
For example, the maintenance department of a dairy factory may need a simple checklist of materials needed for cleaning
milk pails, but the manufacturing department of a chemical company that produces active pharmaceutical ingredients may
require a combination of hierarchical steps and a linear fowchart for its SOPs. A document categorized as maintenance
SOP for cleaning milk pails clearly does not need to be routed to the legal department. But an SOP identifying hazardous
materials throughout the facility may very well need to go to the legal department or regulatory affairs for review because
it may have some impact on compliance with Environmental Protection Agency regulations.

SOP Management: Challenges
Despite the much ballyhooed information age and computer revolution, most companies continue to rely on paper-
based processes. Typically, SOPs are created using Microsoft Word, printed out, and stored in three-ring binders.
The binders are then routed physically from one approver to the next. Once approved, the contents of the binder are
photocopied so every affected department will have one binder handy.
For a small organization, this process may be just fne. But for most companies, a manual system poses many challenges,
including:
Ineffciency The process of routing, reviewing, and approving an SOP can be slow and ineffcient. This is
especially true if an organization generates hundreds or thousands of SOPs and the people who need to review and
approve them are in different locations or out of the offce. It is likely that SOPs may get lost while being routed,
either buried in someones messy desk or computer in box (if routed via e-mail). Search and retrieval of SOPs
would entail sorting through voluminous paper work. Updating SOPs would be equally slow. In addition to going
through the same routing and approval process during revision, obsolete paper documents must be disposed of.
Poor Communication In a manual system, quality processes are not connected, making it hard for people who
operate those processes to communicate. To speed up the approval of an SOP, the originator needs to make phone
calls, send e-mail messages, or remind approvers in person and thats just one SOP. Multiply the number of
phone, e-mail, and personal reminders a dozen times for an employee responsible for a dozen SOPs. In a fast-
paced organization (i.e., a company with 24/7 operations in multiple facilities all over the world), SOPs are likely
to change constantly, but people affected by the changes may not be notifed in a timely manner.
Lack of Training Its bad enough that employees are not notifed about new (or newly revised) SOPs in a
timely manner, but its worse when they dont get the appropriate training on the new SOPs. This failure to keep
up with training on new SOPs is inherent in a manual system thats not connected to the training control process.
So, employees may be using new SOPs but they may be doing it poorly without the appropriate training.
Ineffective Documentation Effective implementation of SOPs has a direct impact on product quality, and that
is why its critical for organizations to capture accurate and up-to-date information in SOPs. But it takes a lot
of time and effort to manually update SOPs, so employees may sit on updates, jeopardizing conformance. It is
equally diffcult to rely on employees to always remember to document any changes in an SOP, including who
made the change, why, and when.
Poor Revision Control Companies that rely on a manual system often complain that it is diffcult to get rid
of obsolete documents. Even after SOPs have been revised and approved, old documents may resurface on the
shop foor. Another problem is that employees may use documents that have not been approved simply because
they are able to grab that binder sitting on someones desk. In both cases, using uncontrolled SOPs could lead to
nonconformance.
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SOP Management as a Compliance Tool
Poor Collaboration Creating and updating SOPs usually require collaboration. For organizations that
use manual processes, collaboration would entail face-to-face meetings and passing around a document that
employees take turns editing. This manual process works when there are few collaborators who are based in the
same facility and whose schedules are similar. But collaboration among employees with varied schedules and
responsibilities and who are based in different facilities will be practically impossible.
Lack of Visibility Paper-based processes are not connected, making it diffcult for management to monitor
the effectiveness of SOPs and make timely decisions. For example, if the customer complaint process is
not connected to either corrective/preventive action (CAPA) or change control, it may take a while before
management realizes that a certain complaint should have been escalated to CAPA and should have resulted in a
change in a manufacturing SOP, perhaps preventing a product recall.
MasterControl Solution
The MasterControl quality management suite consists of confgurable, easy-to-use, and integrated applications for
automating, streamlining, and effectively managing SOPs and other documents, change control, training control, audits,
corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a
single Web-based platform.
Hundreds of companies worldwide use MasterControl to facilitate compliance with FDA regulations and ISO quality
standards. Heres how MasterControl can address the challenges discussed earlier.
Effcient System MasterControl automates routing, delivery, and storage of SOPs, greatly increasing the
effciency of SOP management. The system provides a secure, centralized repository that makes search and
retrieval easy. SOPs will not get lost because the system can track every documents exact location.
Effective Communication With MasterControl, follow-up is automatic. The system will continue to send
notifcations until the person acts on an SOP. It incorporates escalation, so if the person is unavailable for a period
of time, the SOP will move to the next person authorized to approve it. A Web-based platform allows even off-
site or traveling employees to participate in the review and approval process through the Internet. Even suppliers,
consultants, and other third parties may be given limited access to the system so they can be immediately notifed
upon approval of changes to SOPs that affect them. As an alternative, external links can be created to make
selected documents and processes available without giving them system access.
Integrated Training By integrating training control with SOP management and other quality processes, all
employees affected by new or revised SOPs will be automatically sent training tasks. MasterControl automates
assignment, monitoring, and verifcation of training tasks. The system also automates grading of online exams. It
allows implementation of a progressive training program by sequencing training courses. Once a prerequisite is
completed, the next course is automatically launched.
Effective Documentation MasterControl makes it easier to keep SOPs accurate and current. To update or
revise documents, there is only one place to make a change because all SOPs will be stored in a centralized,
Web-based repository that can be accessed by authorized users from virtually anywhere. There is no need for
employees to remember to document changes because the system provides a time-stamped audit trail that captures
the identity of anyone who creates, views, or changes an electronic record, when the action occurred, and the
changes made. Along with the stamp, users are asked to enter a reason for every change.
Automatic Revision Control Employees will no longer use uncontrolled SOPs because only approved
documents will be released and made available to them. Obsolete SOPs will not re-surface. With MasterControl,
when an SOP is revised, the original version is automatically archived upon approval and release of the revision.
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SOP Management as a Compliance Tool
Also, setting an expiration date will make an SOP obsolete on that date and it will automatically be archived.
Automatic revision control will ensure that when an SOP is being revised, it will not be available for check out
until approval of the revision.
Improved Collaboration A virtual collaboration workspace allows individuals to participate at their
convenience. They can review, comment on, revise, or approve an SOP without having to be physically present
with the rest of the team. Redlines will be visible to all team members so there wont be duplication of efforts.
A Web-based platform allows even off-site or traveling employees to collaborate.
Increased Visibility MasterControl makes the entire quality system visible by integrating different processes
and connecting different departments. Management will be able to monitor the effectiveness of SOPs in a
single, integrated system better than in separate processes. For example, a serious customer complaint will be
automatically escalated to CAPA, which in turn will trigger a change in all relevant SOPs. Advanced analytics
and reporting capability will also help management get a real-time view of the quality system to continuously
improve it.

Conclusion
For FDA-regulated and ISO-certifed companies, SOPs are more than just a tool of operation. SOPs directly affect product
quality, and therefore, compliance. Development of effective SOPs and implementing them properly require commitment
from the entire organization. Choosing the right software solution that will facilitate and improve SOP management
should be a part of this commitment. Once established, an effcient and effective SOP management system will serve as a
foundation for an organizations sustainable compliance and long-term success in the market.

Related Videos
Why companies Choose MasterControl
Using MasterControl for FDA Compliance
Using MasterControl for ISO Compliance
About MasterControl Inc.
MasterControl produces software solutions that enable regulated companies to get their products to market faster,
while reducing overall costs and increasing internal effciency. MasterControl securely manages a companys critical
information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate
and easy to use. MasterControl QMS and QEM solutions include quality management, document management/document
control, product lifecycle management, audit management, training management, bill of materials, supplier management,
submissions management, and more. Supported by a comprehensive array of services based on industry best practices,
MasterControl provides our customers with a complete information management solution across the entire enterprise. For
more information about MasterControl, visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.);
+44 (0) 1256 325 949 (Europe); or +81 (3) 5422 6665 (Japan).
2012 MasterControl Inc. All rights reserved.
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