Author: Kia Kahhali, founder and CEO, APS Compliance Consultants Inc.
The biggest challenge of integrating CMMS in The Pharmaceutical industry
In part one and part two of this article, we discussed the particularities of Maintenance in pharmaceutical industries and the main challenges facing maintenance departments. We also discussed how an adequate CMMS can help you overcome this challenge.
However, integrating CMMS in the pharmaceutical industry has its own challenges, which are discussed here.
With all the obvious and major benefits of Computerized Maintenance Management Systems, we still observe that they are not yet integrated into Pharmaceutical operations.
Many companies do not yet have any CMMS and those that have one, either under-utilized or are not validated.
As a consulting firm, we often see hybrid management systems within maintenance departments.
These hybrid systems may keep the UIN (Unique Identification Number) list in a spreadsheet, store the plans and records as paper files and schedule maintenance activities with a computer system. Whenever a hybrid system exists, the computer system gets preference because it’s easier. Paper systems are neglected, and maintenance job work orders get lost. An auditor will target this area because it’s often difficult for companies to get it right.
The biggest challenge to integrate CMMS into pharmaceutical operation is its validation which can be a very complex and costly project. Therefore, validation should be included in the budget for any CMMS in regulated industries.
The fact is that there are not many CMMS in the market that can comply with high standards of pharmaceuticals and their applied regulations, namely FDA 21CFR Part11 and EMA Annex 11.
CMMS systems are mainly built for nonregulated industries and there are many of them offering very useful features and functionalities, and to make the product more versatile to adapt to different industries and processes, they are highly configurable.
The issue is that even those systems that are claimed to be 21CFR Part11 compliance-ready, require a great amount of configuration and settings prior to be compliant. And the more a system is configured, the more its validation becomes costly and complicated.
Choosing a Computerized Maintenance Management System (CMMS) suitable for Pharmaceuticals
A suitable CMMS for pharmaceuticals must be able to address GMP claiming problems facing maintenance departments, and being compliant to 21CFR Part11 requirements, with minimum configuration.
A CMMS that has been specifically designed for pharma industries, must have had embedded most requirements applied by 21CFR Part11 and the data integrity principles. This makes the solution less versatile for other industries but makes it robust and can be easily validated in a regulated environment.
Using mobile technology is a must, entering all the necessary information for each intervention is extremely simple for maintenance technicians, Operators can go through the intervention history and communicate the problems and managers will be able to consult the data and reports, anytime and from anywhere in the plant.
Very often, organizations have other computerized systems like LIMS, QMS and ERP in place that can be linked with CMMS to get the most out of the investment, so the interfacing possibility is another important factor to maximize your investment and system expansion capabilities.
Another important selection factor is the validation services available by the vendor.
CMMS is considered a Gamp5 Category4 computerized system and its validation is subjected to a lot more than just the IQ and OQ. Therefore, the validation package and supports that the vendor offers matter and can drastically reduce the project cost.
Unquestionably, CMMS offers considerable advantages to companies that dare to take the plunge and integrate it as both a management tool and an asset to improve conformity.
Let’s bet that the Pharmaceutical industry will soon meet this challenge as more CMMS designed for this industry begin to be available on the market.
ABOUT THE AUTHOR
Kia Kahhali is the founder and CEO of APS Compliance Consultants Inc.
For Corresponding, contact kkahhali@apsinco.com
With over 20 years of experience in the Pharma industry, Kia has accomplished to build himself a unique profile. This was achieved by tying his electronics engineering and software development background to GMP Computer System Validation and Analytical Instrument Qualification and Management.
With the technical and regulatory knowledge of risk-based equipment and system lifecycle management, business processes, and successful industry records, he is actively working as a reliable resource for many companies looking for selection, Installation/implementation, maintenance and validation of their equipment and systems.