|A cleanroom generates numerous
documents that need to be
controlled for compliance purposes.
A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).
For companies regulated by the U.S. Food and Drug Administration (FDA), requirements 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 (2).
Document control is a fundamental quality process with many challenges, which could potentially lead to noncompliance. The following are three of the most common issues that affect quality compliance involving cleanroom and controlled environments personnel.
#1 Long document cycle times due to inefficient distribution, review, and approval of documents.
To maintain a cleanroom and train its personnel, organizations generate numerous records and documents that need to be controlled and managed like other quality documents. 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 documents efficiently and effectively.
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Ten Most Common Reasons for FDA 483 Observations and
Warning Letter Citations in Medical Device Environment.
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The biggest problem for companies that use paper or hybrid processes lies in administration. When the cleanroom and quality departments create documents, they must route those files for review and approval either in person or through email. Follow-up is also conducted by email or 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’s difficult to manage hundreds or thousands of documents, especially if they undergo multiple revisions and regular updates.
Many companies have successfully reduced their review and approval turnaround time significantly after automating their document control process. A manufacturer of nutritional supplements noted that its document-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, 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 if the system allows users to participate in quality processes with mobile devices.
#2 Lack of control in the change control process.
This happens when paper copies of old SOPs and other procedures continue to surface. It can also happen when there is no effective document control mechanism to alert managers of the need to update documents.
Where companies usually run into trouble in the distribution of new revisions is not knowing where all the copies of the old revision are. Having a system that allows you to lock down uncontrolled copies and facilitates tracking of controlled copies will solve this problem.
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, but often processes evolve without the documentation being updated. A regular document review process can help ensure necessary changes have been documented and that the actual process and the documented process are in sync.
#3 Training can fall through the cracks due to lack of connectivity between the document management and training management processes.
Once a quality document is approved, affected employees should be notified and provided access to the document so they can be trained on the document prior to its effective date.
So, if your organization has implemented an extra wipe-down of the cleanroom as a result of an audit observation, make sure all cleanroom operators understand the change and are given enough time and appropriate tools to perform the new task. Make sure your GMP records reflect this additional wipe-down for the benefit of your next audit.
In a paper or hybrid quality system, it’s easy for training to fall through the cracks because the document approval process is not connected to the training process. Someone has to make sure that when a quality document is approved and released, the corresponding training will be conducted. With an automatic quality system, you will be able to integrate document control with your learning management system to ensure that training tasks related to important documents will be implemented.
Going back to our example above, once the SOP explaining the additional wipe-down is approved, the system will automatically notify all affected personnel of the change. It will seamlessly trigger the training of cleanroom technicians on the updated SOP.
In cleanrooms and controlled environments, just like in other regulated environments, document control is the foundation of quality. To ensure compliance, all procedures and processes that directly affect product quality and safety must be documented. In turn, all important documents (and the process for changing those documents) must be controlled.
Dave Hunter joined MasterControl in 2002. His extensive technology experience includes working for Microsoft, EDS, Intel, and TenFold for over 20 years. He received his bachelor’s degree in electrical engineering and his MBA from Brigham Young University.
(1) FDA warning letter to Excelsior Medical Corp., issued on Nov. 7, 2014,
(2) For medical device companies, see 21 CFR 820.70 (Production and Process Controls),
For pharmaceutical companies, see 21 CFR 211.67 (Equipment cleaning and maintenance) and 21 CFR 211 Subpart C (Building and Facilities), Subpart D (Equipment) and Subpart J (Records and Reports),
(3) From a case study, “MasterControl Helps Weider Nutrition International Stay on Top of its Document Control and Change Management Processes,”