A Validated CMMS Helps Small Companies Meet Regulatory Requirements

Image showing that there are several factors to consider in a CMMS. GxPReady CMMS is a validated system that can meet your needs.

Get a validated CMMS to make your calibration and maintenance run smoothly

We are a small company. Do I need a validated CMMS, and when should I invest in that?

Small companies must mitigate maintenance costs and avoid unnecessary spending because, unlike large organizations, they have restricted budgets and less potential to absorb shocks. Maintenance management is a crucial area that can prevent unforeseen expenditure in the longer run.  If the company is regulated by the FDA or EMA, it needs to have some type of GxP compliant system in place as it works through clinical trials to having a viable product.  

GMP-regulated companies should decide on implementing validated CMMS systems to meet maintenance, validation, and calibration objectives. Maintenance management software helps reduce unplanned downtime, irrespective of the company’s size.   Validated systems provide reliable operation and can reduce confusion and rework, while enhancing the ability to trace issues, such as the effect an out of tolerance condition might have on work that has been done.  

Why should a small company consider a validated CMMS

Using spreadsheets and log books may appear practical and justifiable for a small company with limited inventory tracking and work scheduling needs. It may be easy to track the calibration and maintenance because of manageable compliance needs. 

There are several reasons a small business should opt for a CMMS solution:

Compliance

Greater compliance needs and requirements of planned maintenance, calibration, and validation may not be easy to maintain in log books or spreadsheets. It requires numerous worksheets, creating confusion. Updating files in different workbooks can cause an increase in workloads and the possibility of mistakes. A CMMS software helps maintain all critical data in one location and eliminates the need for periodic updating of the information.  In addition, many software systems intended for non-regulated business use cannot be easily validated.

Real-time picture

Accurate and comprehensive information in real-time is the most crucial requirement for preventing delays in taking necessary action to avoid possible damage. Managing several spreadsheets and updating these can lead to extensive delays. CMMS solutions allow instant updating and visibility of information in real-time for timely corrective action.  At any given point, you can see the status of your equipment with regard to calibration, maintenance, and validation status.

Simplifying audits

Spreadsheets may help store audit data, but these are not suitable for extracting necessary data during the audit process and they don’t have a solid audit trail like you will find in validated CMMS software. Taking out the relevant files for audit inspection can be daunting if you maintain data in spreadsheets. You can access an entire trail of soft copies related to different actions during audit time using CMMS software instead of spreadsheets.

Mitigating errors

Human errors can easily to sneak into spreadsheets and logbooks for maintenance management. There is always a probability of copy-paste mistakes or hitting wrong keys while updating or maintaining data in spreadsheets. Simple errors can jeopardize the entire compliance or maintenance schedule.

Enhancing manager’s contribution

Maintenance Management Systems reduce the burden of administrative work on managers. Maintenance managers can focus on their priorities by avoiding the huge workload of maintaining data in spreadsheets.

Reminders and notifications

One cannot automate the process of notifications by using spreadsheets for predictive maintenance tasks. CMMS software systems can trigger reminders for maintenance as per the scheduling.

You can schedule maintenance in the software by using guidelines from the manufacturer. There is an instant updating as soon as the tasks are over. The system is also helpful for keeping a record of previous maintenance activities.

Time to adopt a validated CMMS 

Small and progressive companies reach a stage when they must grow out of the spreadsheet mindset. Using spreadsheets to keep track of maintenance and validation may become challenging as the company grows, and there is a greater requirement of compliance and trials.  

A validated CMMS can be simple and reliable saving you time and precious resources while keeping you on track and in compliance.

The traditional method of log books and spreadsheets is no longer helpful for scheduling maintenance. The following challenges are notable as the company makes progress:

  • Day-to-day updating of data in spreadsheets 
  • Difficulty tracing the changes in spreadsheets
  • Allowing information access to employees responsible for particular equipment
  • Non-compliance risk because of approval processes

Constraints of on-premise CMMS solutions

Affordability is a major concern in embracing CMMS software, as the initial equipment and software costs are prohibitive. It can jeopardize the critical goals of the company. The time to migrate to the new system can be pretty long because of coordinating various aspects of the business on the single platform.  On line solutions that are validated can provide a great option.

Small companies may not have enough staff to deal with the complexity of handling a new system that is not tested. The steep learning curve may cause a loss of work hours for a small business. A company’s reputation can suffer if regulatory agencies or customers determine that the company is using a system that does not support GMP compliance.

Choosing the right CMMS for a small company

Small companies should safeguard their resources to meet the unanticipated challenges and comply with the regulatory requirements. The new generation of cloud-based CMMS software is perfect for small companies because of its remarkable affordability, and in some cases, the ability to get up and running very quickly.

Web-based alternative of GMP compliant CMMS solution is the right choice for small GMP-regulated companies. Implementation of cloud-based systems ensures remarkable economy, flexibility, and speed.  GxPReady! Suite is an example of such a software package.  It can have you up and running quickly without a ton of configuration required.  Compliance made simple.

Unlike the highly configurable on-premise CMMS systems requiring high upfront costs and workforce, a validated web-based CMMS system is suitable for small companies. It also allows seamless traceability and helps small companies keep up with validation, maintenance, and calibration.