“Paperless” GMP calibration and maintenance systems became popular in the late 1990’s with the introduction of 21 CFR Part 11. Now, demand for even higher levels of productivity and compliance are driving the resurgence in paperless systems. The goal of any paperless GMP system is to facilitate gains in productivity while maintaining or increasing compliance.
The Cost of Compliance
Traditionally, compliance has come at the cost of productivity and paperless systems were seen as way to automate the compliance tasks that bogged down productivity. First generation systems were inadequate because the technology was not in place for full adoption. Fortunately, we can take advantage of advances in technology to tackle the contradictory nature of both higher productivity and compliance.
Key Drivers Enabling Paperless
The new key drivers enabling paperless systems are:
- Application Platform – Web Based Applications have been available for years, but it is only in the last several years that the user experience as been brought to the levels expected for GMP applications.
- Application Functionality – A key software industry trend has been the development of “vertical” CMMS applications for specific industries. In GMP applications functionality designed for GMP workflow with Part 11 electronic signature has become a reality.
- IT Infrastructure – Rapid adoption of wireless networks used with the low bandwidth of web based applications has dramatically changed the way data is collected in the field.
These elements coming together simultaneously have many Biotech, Pharmaceutical and Medical Device companies taking a renewed interest in “paperless” systems. I see an increase in companies investing in this technology in the Life Science manufacturing environments and providing the strong gains required to remain competitive in our challenging laboratory and manufacturing environments.