Why Switch to Electronic Room Cleaning?
Maintaining a clean manufacturing environment is essential in pharma. The efficacy and compliance of your products and processes relies on accuracy and precision at every step of the manufacturing journey. And that starts with cleaning validation.
If clean rooms, surfaces, equipment or packaging is not cleaned thoroughly, entire batches can become defective and cause repetition of work, loss of profit and FDA Form 483 observations.
Pharma 4.0 is setting new standards across the industry. Traditional methods of cleaning with paper work instructions and cleaning logs no longer meet operations demands. They are labor intensive, slow, and prone to human error. Logbook and form software for cleaning records and documentation are a great way to ensure GMP compliance and facilitate right first time execution.
The problem with Paper-Based Cleaning Records
Cleaning validation is designed to ensure consistency with predetermined specifications and provide evidence that manufacturing has been conducted in line with GMP compliance. The process of cleaning validation produces vast amounts of data that must be recorded and stored. Traditionally, these paper based workflows are stored on the premises in large folders or at a third-party facility. While the existence of those documents meets the regulatory requirement to maintain data, the documents are effectively audit records and little more. They are not easily accessible so the data cannot realistically be analyzed or used. And all too often there are errors contained within the data, which can significantly impact review cycles.
Errors contained in import entries for FDA review are often simple and avoidable. Providing timely, accurate, and complete information will expedite production and reduce the effort required for manufacturing and quality review.
Paper-based cleaning validation is fraught with compliance risks:
- • It is unable to enforce consistency and standardization across multiple sites
- • Work procedures cannot enforce right first time activities
- • Records can be lost, misplaced, or inaccurate
- • Regulatory observations are resource intensive
- • Storing and managing the data is costly.
All these risks are a result of data being managed manually through procedures rather than electronically through cleaning validation software.
The benefits of electronic room cleaning software
Electronic room cleaning software eliminates paper-based records to enable GMP compliance and reduce the risk of human error.
It connects every stage of the cleaning process for real-time data capture and leverages technology to conduct checks. Electronic logbooks can leverage real-time equipment statuses to ensure that only the right rooms or equipment are used.
OpsTrakker electronic room cleaning software integrates with your existing systems and enables configurable room cleaning logbooks. It’s workflow-driven logbooks enable quality by design to guide users through digital work instructions and perform activities right the first time.
Electronic Work Procedures for Room Cleaning
With OpsTrakker, all cleaning records and documentation are securely stored and accessible from a single system. This can significantly reduce review cycles and accessing reports for audits. The information can be used to quickly provide evidence of clean room compliance and to further enhance manufacturing productivity.
With equipment or room status visibility, operators and maintenance teams have a real-time view into plant conditions, at every stage of any process. If at any stage, a piece of equipment is found not to meet predetermined levels of cleanliness, the issue can be dealt with quickly and efficiently to prevent downstream issues and avoid batch loss.
By leveraging a digital system to automatically perform checks, commonly completed by a user using paper, you free up their time to focus on other important activities. Combined with a more comprehensive and speedy cleaning validation process, this additional time can significantly increase productivity and ROI.
OpsTrakker is an industry leader with more than 25 years of industry experience. Our suite of pharmaceutical software products is designed to build automated compliance into modern pharmaceutical manufacturing processes. Check out how OpsTrakker effectively digitizes logbooks, forms, and automates work instructions to help you achieve your digitalization goals.
Our electronic logbooks, eLogBooks, help you get things right the first time, every time.
If you are looking to enhance clean room compliance and reduce the risk associated with paper-based record keeping, get in touch today.