Thinking about making a transition to a new electronic batch records in your GMP operation and getting a good Return on Investment (ROI)?
This decision is easy to make when a manufacturer is just starting to design or build their plant. Since the quality system is being designed and written at the same time, the SOPs can be written to correlate with the electronic manufacturing procedures. The benefits of using electronic systems are well documented. The critical decision is picking the electronic manufacturing system that is best for your operation. You can read through the features and reviews of the different systems that you can access through the EBR Links to help make your choice.
When you already have a paper system or a older electronic system in place, the decision is harder. The questions you have to ask include:
- Why do I need to replace my legacy system?
- What problems do I have with my legacy system that can be solved by an electronic manufacturing system?
- How much downtime and lost productivity can I afford?
- Will the transition be worth the cost?
- How do I get a good Return on Investment?
- What is the best way to make a transition?
The resistance to change is strong. If a manufacturing facility has a paper based quality system that they developed internally and have used for a while, they are reluctant to give it up. There is a fear of the unknown and the fear of losing control. No one questions the utility of these systems; what they question is whether they can afford to make the change in quality systems that many manufacturing systems will require. It can also mean that staff will have to write and adapt to standard operating procedures that they are not used to following. Many quality assurance managers are reluctant to trust something new when what they have is working.
The question then is there a system that is low cost, highly available and reliable enough to win over the skeptics. InstantGMP address all the issues with current systems. InstantGMP is a web-based electronic batch record manufacturing system designed especially for GMP manufacturing which includes pharmaceutical APIs, drug products, generics, OTCs and neutraceuticals. All of the features including equipment and room logs, purchasing, inventory control, specification version control and electronic batch records are available through the internet. A quality system is built into the software code so reliability and GMP compliance are handled automatically. It was developed using both the software development life cycle and software validation standards of 21 CFR Part 11 and the FDA’s Quality by Design approach. It comes with a full set of manufacturing SOPs that can be used with any existing quality system. The key to adoption in companies that currently use paper quality systems is showing how systems like InstantGMP can reduce costs, reduce overhead staff time and improve quality compliance while not interrupting productivity during the installation and training phases.
What is a step wise risk free approach to adopting a paperless manufacturing system?
If a company is steeped in paper based quality systems, there is a strong resistance to changing from something this known to an electronic batch record system that is unknown. Quality Assurance people worry about the transition and whether quality will suffer during this period. Managers worry about the loss of productivity as training takes place and operators get accustomed to new techniques. The best way to address these concerns and to avoid impacting productivity is to use a step wise process for the transition.
Start with non critical functions that are useful in replacing a paper based system. For example, room and equipment logs. After getting the staff comfortable with the logs, add in functions for maintaining specifications with version control. Next to come would be using electronically generated material part numbers and purchasing. Once part numbers with specifications are in use then inventory control can begin. This then provides the ability to update statuses and to track the use of each batch of material on-line. When all of the above are being used effectively, the last step is to add the electronic batch records.
If you have picked a system where each of the major functions can be used independently, you can ease the staff through the transition until the electronic batch records are fully employed. It is at this point that all of the modules can work together. Now the entire electronic batch record manufacturing system is operational and the benefits of productivity enhancement, quality improvement and cost reduction can begin to be optimized.