Industry Brief

Compliance Audits: 4
Solutions to Avoid Failure
 Industry Brief

Introduction
Change might come slowly in regulated industries, but it always comes.
New regulations, global pandemics, and new technology all disrupt the way
life sciences companies approach compliance. Unfortunately, successfully
adapting to change isn’t the only factor when it comes to being compliant.
Companies also have to prove that they’ve adapted. This brings us back to
the old adage, “If it wasn’t documented, it didn’t happen.”

Documentation is an essential part of both regulatory inspections and audits.

Being prepared to show any document upon request within a reasonable
amount of time is no small feat. The COVID-19 pandemic changed most
aspects of our lives, and that included inspections and audits. Considering
the importance of creating and approving a vaccine, regulators could hardly
put all inspections on hold until things calmed down. They had to adapt by
embracing technology and remote approaches.

We might be coming to the “calming down” phase, but that doesn’t mean
inspections will revert to the way they were before the pandemic. In fact,
regulators and life sciences companies discovered they liked some of the
changes brought on by the pandemic. The new approach is expected to be
hybrid, combining some remote elements with what has traditionally been
associated with an on-site inspection.

The best way to adapt to these and future changes is by moving to an

electronic quality management system (eQMS). Moving documents, training,
audit, and corrective action/preventive action (CAPA) management to a digital
format makes it easier to plan audits and inspections, produce what is required
during an audit or inspection, and deal with any CAPA that needs to follow.

The COVID-19 Effect

The pandemic forced people to find ways of interacting with each other
from a distance. This was especially disruptive when it came to professional
environments and even more so for those in regulated industries. Regulators
worldwide began adjusting their inspections to accommodate social distancing.
Any company doing business in multiple countries found itself trying to keep
pace with changes in each country and deal with a pandemic at the same time.

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While not every country did the exact same thing when it came to regulating
pharmaceuticals and medical devices, there were some common themes.
The International Coalition of Medicines Regulatory Authorities (ICMRA) is
a worldwide group of regulatory authorities that work together to support
international cooperation. They formed a COVID-19 working group and recently
published their findings on remote approaches to good clinical practice (GCP)
and good manufacturing practice (GMP) inspections during the pandemic.1

This working group provides insight into commonalities among worldwide

regulators on how they approached inspections during the pandemic.
The group included regulators from the following countries and organizations:

Sharing documents, facility tours, accessing electronic systems, and interviewing

subject matter experts (SMEs) were the common ways regulators practiced
remote oversight. To a certain extent, these are expected to continue beyond the
pandemic. However, there are some notable challenges to doing these things
remotely.

One of these issues was paper documentation. For organizations relying on paper,
the records had to be located, scanned, and then securely sent. This is at least
part of the reason why remote inspection activities actually take longer than on-
site ones.

The future will combine the best of both worlds, using effective remote tools
with on-site inspections. According to ICMRA’s report, “While the ICMRA group
have found remote inspections an enabling tool to maintain at least a minimal
regulatory oversight during the pandemic, it is not the view of the group that
remote inspections would fully replace an on-site inspection programme.”²

4 Solutions to Audit and Inspection Pains

Audits and inspections might be taking on a hybrid approach, but the problems
associated with them are very similar to what they’ve always been. Four common
inspection concerns revolve around documentation, training, CAPA, and how to
manage everything associated with the audit. The solutions to those problems
are:

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1. Document control software — gives you complete control over your

documents, including version control, and makes documents easily accessible
and searchable.

2. Training management software — automates training by sending out tasks

and reminders to employees and quickly shows managers who has been
trained on what.

3. CAPA management software — connects to other parts of quality event

management so CAPAs are tracked and followed up on automatically.

4 Biggest 4. Audit management software — connects all audit-related tasks, including

planning audits and creating audit reports.
Inspection Pain Points
These four solutions have merit on their own, but they work best in an
1. Document Control
interconnected system. Systems operating on a single platform can exchange
2. Training Management
information and improve automation.
3. CAPA
4. Audit Readiness Document control in general is a hard thing to master even without taking audits
and inspections into consideration. A standard operating procedure (SOP) is a
good example. If a life sciences company needs to update an SOP to be compliant
with a new regulation, first they must track down the most recent version of the
document. Depending on the QMS, that can mean looking through filing cabinets
or checking the desktop of every person in the quality department

Once they’ve found the right version, they have to find all copies of it, including
both physical paper copies and files individuals have downloaded. Those all have
to be destroyed and replaced with the new version. It doesn’t end there because
certain employees then need to be trained on the changes and the quality
department needs to demonstrate that training happened during an inspection or
audit.

Those pains disappear when a company uses an eQMS such as MasterControl.

MasterControl Quality Excellence provides integrated document and training
management. The SOP example looks much different on an eQMS. Because it’s an
electronic system, there’s no initial hunting around to find the most recent version.
Our document management system automatically archives the old version every
time a document is updated. This ensures only the most recent version is used.

This alone doesn’t provide complete document control. Employees have been
known to download documents to their computers to avoid going into the
eQMS every time they need to reference it. That’s why MasterControl offers
functionality to prevent those files from being used indefinitely. If someone
downloads a PDF to their desktop, the quality department can configure the
system to limit the amount of time that that PDF can be accessed on someone’s
computer. When that PDF no longer works, the employee will have to go back into
the system and use the most recent version.

Even when you have an electronic system, there might be times when you need to
print a physical copy of a document. Controlled copies are integral to compliance,
so this scenario is one that we’re prepared for. MasterControl has controlled
copies functionality, but the real benefit comes from using our integration with
Impact Systems’ Print Control Services (PCS). PCS provides much more control
over printed copies and seamlessly lets users move from MasterControl to print in
PCS and then back to MasterControl.

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Now that the document aspect of inspections is completely under control, what
about training? MasterControl users can program training tasks to automatically
be sent out when a new version of a document is created. Managers can also
access training matrices that show at a glance what their employees should be
trained on and if they’ve completed that training. It’s easy to see if employees are
trained and immediately pull up that evidence to show an auditor or inspector.

Data integrity is also important to compliance, but difficult for companies to

maintain. The standard acronym for data integrity is ALCOA — attributable,
legible, contemporaneous, original, and accurate. These are the characteristics of
good data integrity practices. With built-in audit trails, MasterControl customers
always know who input data, if anyone has changed that data, and when that was
done. Legibility is a nonissue with a computerized system.

Document, training, and audit management cover the most common pain points
experienced during the audit or inspection. With an eQMS, companies save hours
of time normally spent on tracking down documents and proving compliance. Not
to mention the money saved by not having to deal with fees or delay go to market
because of regulatory issues. Companies also free up their quality personnel to
focus on quality improvement measures, rather than tracking down documents.

The Aftermath of an Audit or Inspection

Getting through the audit or inspection is half the battle. Audits provide a bit more
flexibility than inspections in that the company being audited doesn’t necessarily
have to implement every request of the auditor. There’s a big difference between
a customer request, for example, and a regulatory “request.” Findings from an
inspection require timely corrective action not just to prove compliance but to
ensure that the next inspection runs more smoothly.

Depending on the QMS being used, companies can sometimes implement the
corrective action before the inspection or audit is even over. When this can’t
be done, timely follow-up is vital. Tracking the audit findings, the corrective
action, and making sure it works correctly are all actions that are faster and
easier to ensure when using an electronic system. When dealing with paper or a
disconnected system, the audit findings have to be relayed to the CAPA system.
Once the quality department determines the action required, this has to be
recorded. That needs to be followed by monitoring to ensure the issue doesn’t
recur and that the corrective action doesn’t introduce more problems into the
system.

CAPA in and of itself is a big undertaking for quality. When it’s associated with an
inspection, it’s even more important because it deals with the regulations that
ensure safe and effective products. Consequently, a comprehensive electronic
CAPA management system is vital. This is what MasterControl provides to its
customers.

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One of the benefits of MasterControl CAPA is that a user can launch a CAPA form
from other parts of the system. If a user is looking at audit findings, he or she can
initiate a CAPA from the audit module, which automatically populates the fields
of the CAPA form with data from the audit finding. This prevents data integrity
issues that can come from manually transcribing data and saves the user time.
It also automates parts of the CAPA process that can sometimes be lost when
everything is done manually.

If an audit finding leads to a CAPA, that can lead to a change in an SOP or work
instruction. If this happens, then the same MasterControl benefits that come from
an integrated system mentioned above also apply here. The user can go directly
from the CAPA to the SOP, make the change, and the system automatically sends
out training tasks to ensure the corrective action is implemented.

Conclusion

Audits and inspections are necessary and not always a bad thing for companies,
but they are stressful. When properly implemented, the right technology has the
potential to greatly reduce the stress associated with audits and inspections.
There are plenty of digital systems that can help life sciences companies manage
audits, CAPAs, documents, or training, but there are very few that let you manage
all of those and more on the same platform.

Regulators are going to make more in-person appearances as COVID restrictions

loosen. Being prepared for those appearances means having the technology
and resources necessary to deal with the virtual and in-person aspects of an
inspection. Regulators don’t require that life sciences companies use digital
systems, but it is easier on everyone involved when they do. Life sciences
companies that embrace digitization are setting themselves up for success in
audits and inspections — remote and in person — but also in the marketplace as
they get to market faster with higher quality products.

Sources:

5. “Reflections on the regulatory experience of remote approached to GCP and

GMP regulatory oversight during the COVID-19 Pandemic,” International
Coalition of Medicines Regulatory Authorities (ICMRA), Nov. 26, 2021.

6. Supra note 1.

About MasterControl
MasterControl Inc. is a leading provider of cloud-based quality and manufacturing
software for life sciences and other regulated industries. For three decades,
our mission has been the same as that of our customers – to bring life-changing
products to more people sooner. MasterControl helps organizations digitize,
automate, and connect quality and manufacturing processes. Innovative
MasterControl tools have a proven track record of improving product quality,
reducing cost, and accelerating time to market. Over 1,100 companies worldwide
use MasterControl solutions to streamline operations, maintain compliance, easily
analyze and interpret large amounts of data, and visualize business insights in real
time. For more information, visit www.mastercontrol.com.

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