Since our focus is the lifescience industry, all our solutions are designed for 21 CFR Part 11 compliance. We maintain our hosted applications, our network infrastructure and our physical infrastructure in a validated state.

All of our abacusBPM applications are designed with 21 CFR Part 11 compliance in mind. Our applications have detailed audit trails and security for protecting all customer data. In addition to the technological features of the software that enable 21 CFR Part 11 compliance, abacusBPM has strong procedural controls to manage physical and procedural security and data management for all our applications and their data

Our IT infrastructure provides a qualified environment in which all the abacusBPM applications are able to function. We maintain our network in a qualified state using a proven Accretive Model outlined below.

Maintenance of the network in a qualified state draws a line of separation between the abacusBPM applications that reside on our qualified network itself. The network, due to its dynamic nature and ability to morph, is treated as a set of services that provide a clearly defined interface to our abacusBPM applications that require the use of either some or all of these services. The definition of the requirements interface is the glue that holds our qualification model together.

We then designed the various network services based on the requirements interface and using the basic design criteria of Scalability; Availability; Security; Manageability; and Agility, it provided us with the basic framework needed to launch our focused qualification efforts of each service. Each service is then qualified to prove that the original requirements and design objectives are met. (See Network Infrastructure Services figure)

Each of our abacusBPM solutions and custom instances gets thoroughly validated using our robust Computer Systems Validation Methodology (CSVM). Our CSVM exceeds the requirements of GAMP. Our CSVM exceeds the requirements of all our customers and the FDA.

Our application development lifecycle fits hand-in-glove with our CSVM and together we provide robust, high quality solutions that meet all the compliance requirements of the lifesciences industry

Our Computer Systems Validation (CSV) methodology strives to achieve the 4 Rs (Reliability, Robustness, Repeatability and Risk Based) in any application we validate.

Our System Development Life Cycle Methodology (SDLM) exceeds the requirements of industry standards such as GAMP, ISO, etc.