When it comes to a contract manufacturer’s facility, there are two distinct differences that define the specific needs of CMOs over other Life Sciences companies. These factors include that CMOs serve multiple customers and live in a highly competitive landscape.
Serving Multiple Customers
Typical Life Sciences customers may manufacture many product lines for a single company and generally over a long period of time. Contract manufacturers, however, produce many product lines for many customers in a short term period – meaning that their facility and equipment structure changes frequently. Equipment configurations can change from batch to batch and from customer to customer. This is why it is important to have a single system that allows for tracking production equipment and instrumentation at the individual batch level. This requires a CMMS or EAM designed for the task. A CMO may have hundreds of batches with many customers over the course of time.
Serving multiple customers require:
- Comprehensive equipment lists including availability, design capability and performance characteristics of equipment – Equipment lists are used to work with customers in designing their processes and also for marketing purposes.
- Complete history and status of equipment used for each batch – The information is typically referenced in the batch record and therefore GMP centered.
- Recipe and Batch Automation – The ability to create snapshots of equipment layout, configuration and usage for any given time. Many companies integrate the data within the electronic batch record.
- Software to Support Streamlined and Frequent Audits – Contract Manufacturers need fast access to equipment records and audit trails during both FDA and Customer audits
- Tracking of Equipment Configurations including
– Frequently Changing Physical Locations
– Control System Parameters – Version/Recipe
– Under GMP Change Control
– Equipment Traceability – where used – lot, batch, etc.
Highly Competitive Landscape
The Life Sciences industry as a whole is very competitive, however, when it comes to contract manufacturing having low operating costs and competitive prices means the difference between thriving and going out of business.
Highly competitive landscape requires:
- Need for purpose built asset management software – CMOs need a solution that delivers maximum value for their given requirements. When it comes to an EAM or CMMS, contract manufacturers need a purpose-built, scalable and fully functional system to meet all of their unique needs.
- Maximizing ROI within both the Software and Facility – Contract Manufacturers look to utilize software functionality for maintenance and calibration while maintaining product quality. This includes functions such as harmonizing maintenance and calibration, workflow automation, embedded documents, paperless and mobile device usage.
- Extending Equipment Lifecycle – One significant way to lower product costs is to extend the equipment lifecycle. This can be done through spare parts management and improved maintenance and calibration scheduling and execution.
In the next blog, we will discuss how Blue Mountain RAM meets the unique needs of Contract Manufacturers mentioned above.
Click here to view a recorded version of our “Blue Mountain RAM for Contract Manufacturers” webinar.
Read the CMO blog Series:
Blog 1: Industry View
Blog 2: Differentiating Factors
Blog 3: Purpose Built EAM & CMMS