The responsibilities of life sciences manufacturing executives are diverse.
Besides overseeing the business and administrative needs, executives are also tasked with finding new ways to lower costs, improve productivity, introduce new policies and processes, and ensure stakeholders and regulatory agencies that each product is consistent and compliant.
However, manufacturers that rely on a paper-based system to ensure the production of quality products are often operating inefficiently, ineffectively and potentially in violation of GMP compliance.
To help life sciences executives gain a better understanding of a Manufacturing Execution System (MES) and learn how it improves productivity, reduces errors, and ensures GMP compliance during the production of consistent products, we have assembled the following guide.
What is an MES?
A manufacturing execution system (MES) is a cloud-based, paperless software system that provides facilities greater oversight, insight and control of their manufacturing processes.
An MES makes this possible by allowing operators to monitor workflows, track raw materials and equipment, confirm documentation, and establish processes that result in high-quality finished products.
All-in-all, an MES helps manufacturers improve productivity and ensure that they maintain compliance throughout the entire manufacturing process from start to finish.
What Capabilities does an MES Offer?
Although many MES software platforms offer differing capabilities, InstantGMP™ PRO software is the only all-in-one manufacturing and quality system. That is, our platform combines a Quality Management System (QMS) with an MES.
While the QMS portion of the system provides quality assurance groups with greater visibility and oversight of the manufacturing process, the MES uses its capabilities to help operators improve efficiency and productivity while remaining compliant.
To accomplish this goal, our MES software allows pharma, dietary supplement and biotech manufacturers the ability to access the following built-in modules and features:
- Electronic Batch Records (EBR) – Designed to simplify the development-to-production processes for Master Production Records (MPR) and Batch Production Records (BPR), this module also provides greater quality control, improves workflow management, and increases safety. Its user-friendly menu allows operators to easily access, view, track and update the project synopsis, materials information, documents, testing process results, and manufacturing instructions for respective MPRs or BPRs.
- Document Management System (DMS) – Using this module, manufacturing facilities can easily store, organize and secure their access to every file, record and video associated with their production processes. Since the DMS is designed to link documents across various production processes, operators can quickly locate documents for review, updates and approvals.
- Inventory Management System (IMS) – With this module, operators can conveniently trace, monitor and record every part of the inventory process. This ensures accuracy, quality, profitability and compliance from the ordering of raw materials to final production. Plus, it allows inventory and production process personnel access to real-time inventory data for accurate material traceability and production control.
- Learning Management System (LMS) – A collaboration between InstantGMP and cloud-based training platform Entrenar.es, this module improves training and onboarding initiatives by assigning specific coursework (training videos, quizzes and tests) to the respective individuals. All test results and certifications are uploaded in employee files upon successful completion.
- Room Log – This feature lets operators schedule and monitor activities (such as production, cleaning, maintenance or inspection) performed in rooms. It also allows users to set reminders for activities, produce alerts for overdue tasks, and automatically record usage logs for accurate documentation.
- Equipment Log – Manufacturers can access this feature to account for every piece of equipment used and stored in a facility. Additionally, they can attach user manuals and warranty information to each item via the Document Management System, view and control the equipment availability, and use a built-in Equipment Scheduler to arrange for maintenance.
Best of all, InstantGMP™ PRO is the only MES software that allows manufacturers to rely on all of these modules and special features without the added expense and inconvenience of purchasing and installing individual pieces of software.
What are the Benefits of a MES?
Highlighting the modules and features included in our MES is informative. However, that information doesn’t fully explain the benefits of purchasing and installing an MES in a manufacturing facility.
Below are some of the key benefits of investing in an MES:
MES Software Makes MPR and BPR Creation Easier
Manufacturing facilities that trust a paper-based system for their Master Production Record (MPR) and Batch Production (BPR) creation and documentation processes suffer from several serious disadvantages.
Each time a new experiment begins, these facilities need to start recording all of their required information in a new, separate notebook. This new experiment will often contain a lot of the same information as the previous one. All of this information then has to be transcribed all over again.
Once an experiment yields the preferred results, all of that information needs to be transcribed in a new document to create the MPR. Then, to adhere to regulations and provide traceability, all of those various notebooks need to be physically stored in a specific location.
This entire process is simplified with our MES.
Our innovative Make To Order Batch Records feature, our MES software allows facilities to record and revise their MPR development process in real time. This eliminates the need to create a new notebook and transcribe all of the necessary information again every time a new experiment begins.
Then, when the experiment proves successful, developers can automatically create an MPR from the final record.
With the MES, manufacturers have the ability to enjoy a more customizable, efficient, and accurate MPR development and creation processes.
MES Software Helps Improve Productivity
Relying on a paper-based system restricts workflows.
When questions or issues arise, operators have to physically track down multiple documents stored in various locations of the facility. In addition to spending time locating the respective Standard Operating Procedure (SOP), log book or document, they then have to spend time reading it.
Manufacturing facilities can replace this outdated and inefficient process with cloud-based MES software.
By using a cloud-based MES, authorized personnel can instantly access, review, and interact with the necessary documents.
MES Software Automates Compliance
To adhere to GMP compliance, manufacturers create SOPs that operators follow during the manufacturing process.
Since these SOPs are fairly complex, operators cannot commit every step of the process to memory. When using a paper-based system, operators have to locate the respective SOP in the facility, then refer to it during production.
Without an SOP, operators may perform the required steps out of sequence or accidentally overlook a key step. If steps are skipped or mis-sequenced, then the facility is no longer in compliance with GMP requirements.
With a cloud-based MES, SOPs are recorded directly into the database and automatically presented to operators via the batch record. Now operators are prompted to perform each step of the process in a specific order with certain controls.
Instead of relying on a paper-based SOPs and operator memory, an MES supplies this necessary information during the production process to assure GMP compliance.
MES Software Reduces Risk
When manufacturing pharmaceuticals, dietary supplements and biotech products, operators must rely on established standards and safeguards to eliminate any possibilities that the final product does not harm patients or customers.
Manufacturers can help reduce risks to end users by using the MES to prompt operators to follow the set standard. This in turn promotes greater operator control over the various flows and steps the raw materials take through the facility.
As each batch production process is completed, the MES provides manufacturers with a clear path they can use to trace raw materials from initial receipt to finished product or from the finished product to the arrival of the raw materials.
MES Software Yields A Significant ROI
Every product that a pharma, dietary supplement or biotech manufacturer completes needs to meet exact specifications. Otherwise the product is rejected, the entire batch is scrapped, and the whole manufacturing process begins all over again.
Since MES software is designed to improve MPR development and creation, increase productivity and efficiency, reduce risks to finished products, and automate GMP compliance, it improves the overall quality of products and reduces scrapping expenses.
When all of these benefits are taken into account, it’s easy to see that MES software yields a substantial return on the manufacturing facility’s investment.
Which MES Is The Right Choice?
Clearly, MES software has many advantages when it comes to improving every aspect of the life sciences manufacturing process.
Yet, with so many MES platforms currently available, it may prove difficult for firms to determine which choice is right for their needs.
InstantGMP PRO is the only software that integrates a QMS with an MES to cover every aspect of the manufacturing and quality assurance processes – without having to rely on multiple pieces of software.
Best of all, InstantGMP PRO software is available at a price point that is more appealing to small to mid-size pharmaceutical, dietary supplement, and biotech manufacturers.
To learn more about our innovative and affordable MES software or to schedule a demonstration, please contact our team today!