Quality Compliance in Cleanrooms
For life science and other regulated manufactur- ers, cleanroom maintenance is an important part of compliance. It’s not enough that you have written meticulous quality protocols and
procedures for maintenance of your equipment and
facilities — it’s equally important to control and
manage all accompanying documentation that will
show regulators that your cleanroom is compliant.
For companies regulated by the FDA, require-
ments pertaining to cleanroom and controlled
environment procedures can be found in predicate
rules such as 21 CFR Part 211 for pharmaceutical
companies and 21 CFR Part 820 for medical device
manufacturers.1 These require documentation of
standard operating procedures and instructions as
well as documented procedures for process changes
related to equipment, buildings, and facilities.
A recent warning letter to a medical device firm
shows the importance of proper documentation and
corresponding control of those documents. The FDA
noted the company’s failure to establish and main-
tain written procedures for avoiding contamination
of equipment, as well as the incongruity between
some of its cleanroom procedures and records of
actual practice. 2
Long document cycle times
To maintain a cleanroom and train its personnel,
organizations generate numerous records and doc-
uments that need to be controlled and managed.
Whether it’s the SOP for sanitizing a cleanroom
against particulates and pathogen contamination or
written materials for training technicians on sterile
gowning procedure, you need to be able to create,
approve, and revise docu-
The biggest problem
for companies that use
paper or hybrid (part
electronic and part paper)
processes lies in admin-
istration itself. When the
cleanroom and quality
departments create doc-
uments, they must route
those files for review and
approval either in person
or through email. Follow-
up is also conducted by email, phone, or in person.
Once approved, those documents are typically stored
in electronic servers, printed in hard copy, compiled
in binders, and stored in filing cabinets in a document room. It is difficult to manage hundreds or
thousands of documents, especially if they undergo
multiple revisions and regular updates.
Companies typically cut down their review and
approval turnaround time significantly after automating their document control process. A manufacturer of nutritional supplements noted that its doc-ument-approval cycle time improved from months
to days after it switched to an electronic document
management system. This company automated
46,000 documents during the switch. 3
With an electronic system in place, routing,
follow up, escalation, and distribution are all automatic, saving time and effort. Obtaining approval
and signatures of stakeholders who are out in the
field or are scattered in various facilities is also easier,
especially users can participate in quality processes
with mobile devices. An electronic document control
system that allows cleanroom personnel to use a
smartphone or a tablet instead of paper documents
is more convenient and efficient for them, which in
turn could help reduce document cycle times.
Lack of control in the change control process
Where companies usually run into trouble in the
distribution of new revisions is not knowing where
all the copies of the old revision are. It helps to have
a system that allows the lock down uncontrolled
copies and facilitates tracking of controlled copies.
Make document review a part of your change control process. Most regulated companies have a document review policy to ensure that important quality
documents are still applicable and accurate. A regular
review process can help ensure necessary changes have
been documented and that the actual process and the
documented process are in sync.
Training falls through the cracks
Once a quality document is approved (either for
the first time or after an update), affected personnel
should be notified and provided access to the document so they can be trained on the document prior
to its effective date.
For example, if your organization has implement-
Addressing common challenges in document control.