Having trouble finding value in paperless GMP manufacturing?

Everyone takes the role of computers for granted in most every day activities.  Smart phones, tablets, PCs and cloud computing are ubiquitous.  So why haven’t small biotech companies and contract manufacturers adopted paperless manufacturing just as easily.  There are at least three reasons: high cost, limited availability and resistance to change.

High initial costs, high training costs and high maintenance costs are the problems often encountered with the most trusted and most visible systems. Fully featured manufacturing execution systems or Enterprise Resource Planning (ERP) systems are expensive, especially the ones that are 21 CFR Part 11 compliant.  Some of the best known systems come from SAP, Honeywell POMsnet, Elan Software (now part of Siemans) and Werum. The basic price for licensing can be hundreds of thousands to millions of dollars plus annual maintenance costs. And that’s just the beginning. The real cost is in the configuration, training and adoption.  It can take months to years to configure a system and a team of consultants are needed to accomplish this task.  Once the configuration is done, it takes more time and support to get the employees comfortable using it.  This option seems to work best in the largest pharmaceutical companies who are able to invest the time and resources to install the system and to make sure everyone involved is trained in how to use it.

The limited availability of low cost, high compliance systems is the prime reason paperless manufacturing doesn’t work out for smaller pharmaceutical manufacturers. There are manufacturing execution systems that are lower priced and easy to install for smaller pharmaceutical manufacturers, however these options are relatively scarce and none come with standard operating procedures incorporated into the software.  Some examples of smaller electronic batch record systems and ERP systems that are 21 CFR Part 11 compliant include Aspen (aspenONE) and APRISO (FlexNet).  Valdata Systems provides manufacturing execution for API manufacturers. CDC Ross ERP is a comprehensive suite of applications for process manufacturers. Others are TrackWise and Mar-Kov CMS (Chemical Management System). There are many more that offer electronic batch records and paperless manufacturing; however, they are not Part 11 compliant.  Most of these manufacturing execution systems are either Windows based or client/server applications.  Few are web-based which means that full time IT support is advisable for the companies who invest in them.

Even through there are a few paperless pharmaceutical manufacturing system available that are Part 11 compliant, 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. We think InstantGMP address all the issues with current systems.  InstantGMP is a web-based paperless manufacturing systems designed especially for pharmaceutical API and drug product manufacturing.  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 GMP quality system is built into the software code so reliability and 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.  The key to adoption in companies that currently use paper quality systems is showing how InstantGMP can reduce costs, reduce overhead staff time and improve quality compliance.  Ask for a demonstration if you need to be convinced.

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