ISO/cGMP Computer Systems Validation

Comprehensive software gap analysis and computer systems validation (CSV) to provide industry standard cGMP validation testing and documentation to demonstrate 21 CFR Part 11 (Electronic Record / Electronic System) compliance for custom or third-party asset management applications. As GMP client and 17025 requirements become increasingly stringent, internal and contract calibration laboratories are now realizing the benefits of having a standard format validation turnover package to provide for audits. A typical cGMP (current Good Manufacturing Practices) validation package will usually satisfy ISO 17025 validation requirements as well.

Blue Mountain RAM Implementation

Simply put, we speak your language. Having a rock-solid understanding of GMP metrology / maintenance / asset management combined with over a decade of experience with Blue Mountain software implementation translates to an immediate and mutual understanding. From concept, configuration, validation, training, to go-live, our BMRAM implementations serve large and small operations, with both complex and streamlined business requirements. Services are performed turnkey, in parallel with GMP consulting or à la carte, as required by the client.

ISO/cGMP Validation Documentation Preparation

cGMP validation documentation preparation for equipment / instrumentation providers who require vendor qualification documents. Extant vendor documentation / knowledge is leveraged to compile turnkey validation documents, intended to be executed by the vendor or customer as a factory acceptance test or site acceptance test. Please enquire here regarding validation scope and expertise.

GMP Calibration Program Consulting

MMcCS has gained a unique perspective of this industry through years of consulting with metrology programs as well as participation in industry organizations. This background provides us with valuable input in GMP metrology consulting from large projects, such as program creation to finer details such as training.

Healthcare Metrology Industry Training

Custom training ranging from multi-day courses covering a wide range of cGMP metrology and asset management topics to client-defined topics addressing areas of particular focus. Class participation ranges from well-seasoned GMP calibration / metrology professionals to the beginner level - the training presentation and material is gauged for the target audience. The courses are also informative for ancillary roles within the asset management / metrology program, such as asset owners and quality assurance personnel. Both onsite and offsite training courses are available.

Sample Course Material

  • Calibration Definitions
  • CFR Overview
  • Introduction to Uncertainty Analysis
  • Asset / Process Relationships
  • Process Limits vs. Calibration Limits and Their Stakeholders
  • Process Limit Guardbanding
  • Asset Criticality / Categorization
  • OOT / Failures
  • QSIT
  • ISO Metrological Standards, Accreditation, Hierarchies
  • Onsite / Offsite Calibration Contract Qualification and Management
  • CCMS Strategies
  • Calibration Master Plan Overview and Strategies
  • Auditing Strategies
  • Introduction / Overview / Strategic Approach to Primary Calibration Disciplines