Consistent Computer System Lifecycle Approach
Planning, Design , Test, Release, Maintenance & Retirement
MCODE
Independent Validation & Verification of Computer Systems
GAMP, Installation & Operational Qualification & Risk-Based Validation Using ASTM E2500
MCODE
ALCOA Principles for Data Integrity
Attributable, Legible, Contemporaneously, Original and Accurate
MCODE Vision
“Our company goal is to have a team of validation personnel with a consistent standard approach rather than validation individuals who are inconsistent and have conflicting views.”
Benefits of MCODE Validation
- Onsite personnel with multiple levels of expertise.
- Access to remote validation team to support project peaks.
- Standard consistent approach to project testing.
- Eliminate project bottlenecks with remote support.
- Generic test script generation: Generate once to use multiple times.
- Test script library saving multiple document generations.
- Utilise specifications for testing to allow parallel test document and design review & approval.
- Template based testing.
- Standard testing approach with robust deviation/incident resolution.
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Independent Validation
Professionals with technical and validation background within this non biased independent service check the software for reliability and performance, as well as its compliance to standard regulations.
Automation System Validation
We offer tailored solutions to the following types of Automation Systems:
Distributed Control System (DCS), Programmable Logic Controller (PLC) Equipment, Electronic Batch Record (EBR) & Supervisory Control and Data Acquisition (SCADA) in the pharmaceutical, medical devices and life sciences companies.
Validation and Verification
When comparing a classical validation with the verification approach, user and functional requirements for each system are generated. In verification the critical aspects are also generated to evaluate and determine the level of validation testing required for each user and functional requirement. In an ASTM E2500 approach, a system impact assessment (SIA) is not needed; rather, the system and control portions with the potential to impact the product are defined by the SMEs. In classic validation, every requirement is tested with equal weight, while in a verification approach, requirements are weighted and tested based upon their impact on the process and product.
With classical validation a vendor is audited and the system evaluated on its capability to meet all user and functional requirements. By contrast, with verification, a vendor is audited to gain a high level of confidence that the system is able to meet all critical requirements.