www.mastercontrol.com
Open in
urlscan Pro
45.60.34.193
Public Scan
Submitted URL: https://t.dripemail2.com/c/eyJhbGciOiJIUzI1NiJ9.eyJhdWQiOiJkZXRvdXIiLCJpc3MiOiJtb25vbGl0aCIsInN1YiI6ImRldG91cl9saW5rIiwia...
Effective URL: https://www.mastercontrol.com/resource-center/documents/6-must-haves-for-a-quality-management-system-qms/?utm_campaign=701PQ00...
Submission: On February 06 via api from DE — Scanned from DE
Effective URL: https://www.mastercontrol.com/resource-center/documents/6-must-haves-for-a-quality-management-system-qms/?utm_campaign=701PQ00...
Submission: On February 06 via api from DE — Scanned from DE
Form analysis 1 forms found in the DOM
<form><span class="fieldset">
<p><input type="checkbox" value="check" id="chkMain" checked="checked" class="legacy-group-status optanon-status-checkbox"><label for="chkMain">Active</label></p>
</span></form>Text Content
Cookie Notice
We use cookies to personalise content and ads, to provide social media features
and to analyse our traffic. We also share information about your use of our site
with our social media, advertising and analytics partners. Privacy Policy
Close
Accept Cookies
Cookie Settings
* Your Privacy
* Strictly Necessary Cookies
* Performance Cookies
* Functional Cookies
* Targeting Cookies
* More Information
Privacy Preference Centre
Active
Always Active
Save Settings
Allow All
Solutions
Back
Our Solutions
Quality
Manufacturing
Solutions
QMS FEATURES
QMS OVERVIEW
DOCUMENT CONTROL
CHANGE CONTROL
TRAINING MANAGEMENT
AUDIT MANAGEMENT
RISK MANAGEMENT
QUALITY EVENT MANAGEMENT
CAPA SOFTWARE
DEVIATIONS MANAGEMENT
NONCONFORMANCE
OUT OF SPECIFICATION
QUALITY MANAGEMENT
DATA AND ANALYTICS
Add-Ons
Postmarket Supplier Product Development
Regulatory Clinical
Solutions
MES FEATURES
MES OVERVIEW
BATCH RECORDS
DEVICE HISTORY RECORDS
EQUIPMENT CALIBRATION
RECIPE MANAGEMENT SYSTEM
VARIANT MANAGEMENT
DATA AND ANALYTICS
Solutions by Industry
Pharmaceuticals Medical Device Dietary Supplements Blood, Biologics and Tissue
Food & Beverage
Pricing
Take a look at our flexible pricing plans and request an estimate that works for
your business.
Services
See the services you need to get you up and running faster and realize value
sooner.
Learning Center
Back
Our Knowledge Base
Resources
Compliance
Integrations
Templates and Guidelines
Learning Center
Resources
Resource Center
White Papers, Videos, Guides and more. Our industry expertise is yours.
QMS ROI Calculator
Answer a few questions and find out your QMS cost savings.
Manufacturing ROI Calculator
Calculate your potential ROI for a modern MES solution.
Blog - GxP Lifeline
Read our newest articles from our industry experts.
Customer Awards
Acknowledging MasterControl customers who have accomplished amazing things.
Learning Center
FDA Regulations
21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270-1271 21 CFR Part 210-211 21 CFR
Part 606 21 CFR Part 820
ISO Standards
ISO 9000 ISO 9001 ISO 13485 ISO 14000 ISO 14971 ISO 15189 ISO 17025
Global Compliance
CLIA Canadian Standards EU Annex 11 EU Medical Device Regulation Therapeutic
Goods Administration (TGA) Regulations
Learning Center
MasterControl Integrations
ERP Software System
Integrate with ERP software to completely digitize your production process.
MRP Software System
Integrate with MRP to improve accuracy, visibility and efficiency in
manufacturing
Manufacturing Resource Planning
Using a more robust MRP II system? We integrate with that too.
Production Operations Management
Quantity of products that are the right level of quality at the right time and
the right cost.
LIMS System
Learn how MasterControl integrates your lab data with quality documentation.
Learning Center
Templates
SOP Template Change Control Template Design Control Template
Guidelines
GMP Guidelines SOP Guidelines ICH Guidelines ECTD Guidelines CDER Guidelines
About Us
Back
Who We Are
Our Company
Events
Become a Partner
About Us
About MasterControl
Learn More
Everything we do is designed to help you develop, manufacture and commercialize
products that help people live longer, healthier and more enjoyable lives.
Our Core Values
At MasterControl, customer success is the core value on which we base our entire
business operating philosophy.
Executive Team
Our executives bring a wealth of knowledge to the cause!
MasterControl In The News
MasterControl is making news and leading the way in solving business problems
for all types of regulated manufacturers.
Careers
Choosing where to work is a difficult decision. Let us make it easy for you.
Masters Conference 2024
14-16 May | Dublin, Ireland
Learn More
Masters Summit 2024
14-18 October | Salt Lake City, UT
Learn More
About Us
Upcoming Events
Learn More
Everything we do is designed to help you develop, manufacture and commercialize
products that help people live longer, healthier and more enjoyable lives.
Masters Summit North America
Join us at our can’t-miss annual event for life sciences quality and
manufacturing professionals.
Masters Conference Europe
Make plans to join us at our European can’t-miss event for life sciences quality
and manufacturing professionals.
Industry Events
Come find us at manufacturing and quality industry events near you. We love
meeting new people and old friends.
Webinars
See thought leaders sharing helpful insights and best-practices for
manufacturing in highly regulated industries.
Masters Conference 2024
14-16 May | Dublin, Ireland
Learn More
Masters Summit 2024
14-18 October | Salt Lake City, UT
Learn More
About Us
MasterControl Partner
Partner Program
Grow your market and revenue with a MasterControl Partnership.
Referral Partners
Earn a commission when your referral becomes a MasterControl customer.
Sales Partners
Go to market with MasterControl, a manufacturing industry leader.
Service Partners
Gain a new revenue stream by becoming an extension of MasterControl’s Services
team.
Technology and Strategic Partners
Offer more value by collaborating on innovative technologies.
Industry Associations
See how we partner with many quality and manufacturing trade associations.
Login
US
English / United States
English / United Kingdom
Français / France
日本語 / 日本
English / Australia 繁體中文
Contact Us
Qx
Quality
Resource Center
6 Must-Haves for a QMS
6 MUST-HAVES FOR A QUALITY MANAGEMENT SYSTEM
In regulated environments, such as those under the jurisdiction of the U.S. Food
and Drug Administration (FDA) and/or International Organization for
Standardization (ISO), quality is included in regulations and standards. So,
quality isn’t just good business sense, but also a matter of compliance and
requires a good quality management system (QMS).
The FDA states that “quality should be built into the product, and testing alone
cannot be relied on to ensure product quality.” The ISO 9000 series of standards
also points out the importance of making quality an integral part of a
manufacturer’s daily operations. In today’s world, doing this requires automated
manufacturing and digital systems
Download Now
6 MUST-HAVES OF A QMS
The best way to build quality into a product is with an effective, connected
digital QMS. This is the foundation for long-term regulatory compliance and
market success. However, not every QMS has the same capabilities and
connectivity. A QMS that isn’t connected to other areas of the company and
requires using rigid processes with little flexibility slows down quality
processes and introduces the possibility of more human error.
Life sciences companies need a QMS that provides functionality across all areas
of quality. This includes document control, training management, quality event
management (such as corrective action/preventive action [CAPA] management), etc.
It also needs to integrate with other systems. The ideal QMS should let you
easily configure it to meet your processes, instead of forcing you to change
your processes to meet the QMS. A QMS that isn’t flexible will always slow down
processes and keep you from making changes to become more efficient. To find
that QMS, look for a system that does the following.
1. ENABLES AUTOMATION
Even in today’s business world, where technology is everywhere, many companies
in regulated industries still rely on paper-based or hybrid quality systems.
While a paper-based system can be compliant, it requires more time and effort to
maintain that compliant state. Every task that is automated in a QMS must be
done manually when dealing with paper. That includes routing documents for
signatures, updating standard operating procedures (SOPs), and locating
documents for an audit or inspection.
Quality systems are complex, but manageable with a QMS that automates all
quality-related tasks for documents and forms, including:
• Routing.
• Tracking.
• Escalation.
• Review.
• Approval.
This applies to SOPs, training records, electronic production records, and
anything else that requires review and approval. Since these documents are all
stored in the same system, a company can be always prepared for an audit with
the most up-to-date version of each document, fully automated change control,
and an electronic signature trail.
Just because a system is automated doesn’t mean it can’t be flexible. Highly
configurable systems let you automate which paths a quality event management
investigation takes based on the data provided. Due to recent advance s in
software validation you can make these changes quickly and then validate them to
ensure you’re operating in a validation state.
2. CONNECTS ALL AREAS OF QUALITY MANAGEMENT
If putting a dollar value on quality is difficult, breaking the concept of
quality into sections is even more challenging. Consider the example of a
defective medical device, in which a new glucose monitor shows incorrect
readings during testing. An investigation of this product would cover the whole
product life cycle. The manufacturer would investigate the root cause of the
problem through its CAPA management process.
In this example, what if the CAPA investigation showed a weakness in product
design? A design change would be initiated and managed through the change
control process. When the change is approved and successfully tested (and proven
safe), this has to be documented. All updates in the documents for this product
would be managed through the document control process. Then, employees need to
be trained on those changes, which is part of the training control process. From
this perspective, it is virtually impossible to manage each aspect of quality as
a separate process.
Since all areas of quality are connected, you need a fully connected QMS for
closed-loop quality management. This QMS would let you document your change
control and gather electronic signatures for approval. When you update related
SOPs, a QMS should automatically send out training tasks to employees. You can
also control which employees receive that training. This helps ensure the
corrective action is fully carried out without letting anything fall through the
cracks .
With a connected QMS, users can enter a quality event, investigate it, determine
corrective action, approve changes to or new documents, and send out training
automatically all in the QMS. This makes it very easy to show your process
during an audit and to quickly pull all documentation related to the original
issue and how it was resolved.
3. PROVIDES ROBUST ANALYTICS AND REPORTING CAPABILITIES FOR EFFECTIVE MANAGEMENT
Today’s manufacturing environment is competitive and fast paced. To get ahead,
businesses must not only ensure product quality, but also have insight into all
quality processes. Those in regulated environments need tools to help them see
trends and understand quality issues to proactively solve problems. Their
ability to adapt to changes and problems quickly can be the difference between a
simple CAPA or a product recall.
Enterprise systems hold all the data you need to make smart decisions for
quality and manufacturing but turning that into predictive quality analytics is
difficult. Collecting and analyzing data takes time, especially if you do it
manually. Even if you’re working with a digital system, Excel data dumps are a
fact of life. It doesn’t have to be that way, though. With quality data that is
always up to date and connected within a digital QMS, all the information you
need is at your fingertips.
An advanced QMS offers features to track, trend, and report on the data within
the QMS. You can use the out-of-the-box reports in the QMS, but also easily
create your own with intuitive tools. The level of detail is flexible, allowing
you to see a broad overview or drill down into the details of the data.
Forward-thinking vendors will offer predictive quality analytics. An example of
this is to tell you if an employee is going to be overdue on training.
Predictive quality analytics and closed-loop quality ultimately improve your
bottom line.
4. FLEXIBLE AND SCALABLE
Automating a quality system is a major endeavor in terms of time, effort, and
cost. Rather than be forced to revamp their system often, businesses choosing a
QMS should consider how the system would support future growth at three levels:
1. Users (by the dozens, hundreds, or thousands).
2. Business units (domestic and/or overseas).
3. Operations (new products and services).
The system must be able to adapt to changes in the market and in the regulatory
environment.
When looking for a QMS, consider how your company may change over time. As you
grow, can the QMS keep up? For example, can you begin using the product with
limited functionality and then expand your use? Can you go live at a single site
and then roll out to others? If you’re part of a large business that has
multiple other enterprise systems, make sure the QMS can integrate with those
systems.
Flexibility is equally as important. A difficult part of user adoption is when
you need users to change how they do things to fit the system. That’s why it’s
easier to find a QMS that can be changed to fit your current processes. This can
be done through custom code, but that makes it difficult to make any changes
without heavy services fees. A no-code QMS that can be configured to match your
processes lets you design your own workflows. Then you can quickly make changes
whenever needed without compromising software validation.
5. PUTS YOU IN AN AUDIT-READY STATE
A big part of passing an audit is finding documents to show to the auditor. When
these are kept in filing cabinets or saved on one person’s computer, finding the
document is a hassle. With a connected QMS, finding documents is easy. You can
quickly search and know that the version you’re looking at is the most recent
one. The needed electronic signatures and audit trail are automatically logged
and easily demonstrated to an auditor.
Some of these documents are training records. Despite training requirements,
many companies fail at keeping employees trained and keeping track of the
records. Not surprisingly, training is among the top reasons for receiving an
FDA Form 483. There are two reasons for this. One is that a lack of efficiency,
visibility, and connectedness means employees can’t perform according to
industry standards. The second is that, even when employees are trained, it is
difficult to find the paperwork that proves they were trained. A training
management system alone can’t solve these problems. But with a QMS that has
automated assignments, monitoring, and verifying of training tasks, you can
ensure training happens and that you can easily find the records needed during
an audit.
6. MAKES CONTINUOUS SOFTWARE VALIDATION A STRATEGY FOR STAYING COMPLIANT
Companies doing business in FDA-regulated industries must have documented
evidence that their computer systems consistently perform as expected, a
practice known as software validation. The FDA also requires companies to be in
a constant state of validation, which generally means they must re-validate
every time they upgrade or change their systems. In some companies, validation
requires months to complete and produces stacks of paperwork to prove validation
occurred.
MasterControl is a trailblazer in simplifying and expediting software validation
for our customers. The patented Validation Excellence Tool (VxT)™ uses a
risk-based approach to validate, which is what the FDA itself suggests. VxT lets
users assess the risk to their business based on how they use the software. By
relying on MasterControl documentation and only doing additional testing for
high-risk features, validation can be done in hours or even minutes . With more
flexible, configurable software, validation needs to continue to evolve.
MasterControl is again innovating with the patented Validation on Demand (VoD
)™. VoD lets users perform next-generation, automated validation testing
targeted to their unique use cases and workflows.
In conclusion, the importance of quality in regulated environments can’t be
overstated. An effective QMS is the foundation of any regulated company’s
compliance efforts. As such, it needs to feature the functionality of a document
control system, training management system, and quality event management system
all rolled into one. This type of QMS doesn’t handle quality as a retroactive
process, but helps organizations continually improve so they can meet
regulations and have a competitive advantage in the market.
MasterControl is an advanced, fully connected QMS and the No. 1 QMS in the life
sciences. With connected document, training, quality event, and audit
management, users can easily manage all aspects of quality on a single platform.
The MasterControl Insights analytics solution, which seamlessly integrates with
the MasterControl WMS, lets users easily analyze their quality data and prepare
visualizations and dashboards. Users can also use artificial intelligence (AI)
functionality to avoid problems before they occur. These features put companies
in a unique position where they can adapt quickly while remaining compliant.
TRUSTED BY
ARE YOU READY TO SEE A QUALITY MANAGEMENT SYSTEM THAT DELIVERS THESE MUST-HAVES?
An effective QMS is the foundation of any regulated organization’s compliance
efforts. A QMS that has the above features will help companies realize maximum
value for years to come.
Download Now
Let's chat
info@mastercontrol.com
Sales+1-866-747-8767
Contact Us
Solutions
* Quality
* Manufacturing
* Clinical
* Regulatory
* Supplier
* Product Development
* PostMarket
--------------------------------------------------------------------------------
Learning Center
* Resource Center
* Blog - GxP Lifeline
--------------------------------------------------------------------------------
About Us
* About MasterControl
* Upcoming Events
* Partner Program
* Careers
6350 South 3000 East
Salt Lake City, Utah 84121 View map
--------------------------------------------------------------------------------
Privacy Policy Cookie Notice Intellectual Property Modern Slavery Act Statement
© 2024 MasterControl Solutions, Inc. All rights reserved.
[ { "key": "fid#1", "value": ["Everything else"] } ]