Gubber Metadata Manager is a modular web-based, highly scalable application used to manage, in a
manner compliant with 21 CFR Part 11, metadata collected, generated, and required during the normal
operation of a scientific analysis laboratory operating in an FDA-regulated environment. Metadata is
managed using the following Gubber modules:
- Analytical Reference Standard Manager
- Analytical Sample Manager
- Document Manager (e.g. SOPs, Laboratory Methods, Final Reports, etc.)
- Equipment Manager
- Problem Reporting Manager
- Equipment Maintenance/Calibration Manager
- Computer System Manager
- Computer System Life Cycle Manager (including Computer System Validation management)
- Training Manager (including event configuration, scheduling, attendance, and personnel summary)
- Purchasing Manager
- Personnel Time Manager
- Project Manager
All accounts, permissions, personnel identification and personnel location are managed by a central
Administrative Console. There are several salient features of Gubber:
- Gubber is web-based. This eliminates the need to maintain validated status of individual
workstations. It also adds to the scalability of Gubber.
- Gubber is higly-scalable. Initial installation can occur at an individual laboratory level, then easily
configured to use at company, corporate or global levels.
- Gubber may be configured such that data specific to a laboratory or department may be isolated to
that laboratory or department. In this configuration, each laboratory or department (or company or
site, depending on the administrative level desired) maintains its own administrative privileges.
This allows departments to manage its data in its own defined manner.
- Customers are not required to install all modules - only the modules needed and purchased.
Currently if a company that maintains scientific analysis laboratories wishes to store all metadata as
electronic records in a compliant manner, managers and administrators must configure several systems
(easily four or more) in order to meet this goal. Such systems typically are client/server based and require
advanced training for support and use. This goal is hindered by several factors:
- The company or laboratory must hire additional staff to administer and support the systems.
- It is likely one or more of the applications will require extensive client-specific modification that will
require additional human and time resources.
- It is likely one or more of the applications will not be amenable to quick and extensive
reorganizations that are increasingly common in today's business world.
- It is likely one or more of the applications will not be scalable to accommodate, not only local use,
but enterprise-wide use.
- User change requires change to all systems by administrators.
- The implementation of several systems increase the chance that users are not configured in a
consistent manner.
- Each system may meet 21 CFR Part 11 requirements at different levels of compliance.
- Instances of users forgetting passwords will increase.
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