So how does MES validation differ from normal everyday computer system validation and software validation? MES or manufacturing execution systems are becoming increasingly more popular in the Pharmaceutical, Medical Device and Biotechnology industry.
So what is it all about, is it worth all of the effort involved to migrate from a paper based system to an electronic based system.
What is a Manufacturing Execution System (MES)
Here’s the technical definition:
A Manufacturing Execution System (MES) is a dynamic information system that drives effective execution of manufacturing operations. Using current and accurate data, MES guides, triggers and reports on plant activities as events occur. The MES set of functions manages production operations from point of order release into manufacturing to point of product delivery into finished goods. MES provides mission critical information about production activities to others across the organization and supply chain via bi-directional communication.
In easy to understand terms, a MES system is software application that is used to remove all of the paper work from the manufacturing floor and replace it with an electronic system.
If you take a look at any Life Science company globally there is a huge amount of paper work generated in order to make a drug substance batch or medical device. Imagine all of the man hours it takes to generate the paperwork, issue the paperwork, fill in the paperwork, review the paperwork, quality review the paperwork and so on and so on….I think you get the idea.
What MES does is reduce all of this work by allowing operators on the shop floor to enter any data that is required into the electronic batch, the beauty to this system is that from a review perspective the approach of “Review by Exception” is used
Whats is Review by Exception
Imagine a paper batch record with over 200 pages of information that needs to be completed by various operators generating a specific batch. There is so much room for error in terms of documentation errors that the review process could be a nightmare for the various review groups (especially The Quality Department), not to mention if the batch has associated deviations and errors.
Imagine a world where the review process only focussed on any exceptions to the record, which means the review team, would be exempt from doing page by page reviews that take hours and as a result they are more time to focus on other aspects of the job.
An MES system incorporating the review by exception approach is that world. The 200 page paper batch record is not a computer record in the system, where only logs are reviewed by the quality team.
This dramatically reduces the overall turnaround time of the batch or product being released to market and saving a huge amount of money in terms of manpower
If you would like to learn more about MES systems, please feel free to contact Premier Validation with any questions or queries
Configurable Manufacturing Model
The manufacturing model is a revision-controlled, auditable, structured definition of products and associated manufacturing processes (Design Master Record). It includes workflows with approved alternate paths, step-by-step operator procedures, parametric data collection with limits and out-of-spec actions, electronic signature requirements, detailed bills of materials and weigh and dispense specifications.
Electronic Manufacturing Audit Trail
Actual production is tracked against this model – either by simple entry forms or directly from equipment – providing the complete history of all manufactured lots, batches and serialized units, spanning production in multiple plants. Materials consumed, processes and equipment utilized, parametric data collected, exceptions, rework, dates and times, and electronic signatures are some of the details captured – creating a secure and searchable electronic Device History Record, Batch Record or Lot History Record (eDHR/eBR/eLHR).
Enforcement, Visibility and Compliance
The MES enforces adherence to processing rules, preventing errors, ensuring compliance, and containing any material that is potentially out-of-spec or compliance. Production and quality data are visible through dashboards and simple inquiries, making it possible to spot exceptions and effectively investigate issues.
