Biotech and Pharma Consultancy
Electronic Qualification Services Ltd.
GxP Instrument / Equipment Manufacturers
“The rapid, cost-effective development, maintenance, and generation of error-free, GxP-compliant Equipment and Instrument Commissioning and Qualification Test Documentation presents a significant challenge.”
This is a challenge we are equipped to help you overcome…
GxP Equipment Manufacturer Validation Issues
In 2010 we were approached by the Head of Service for GE Healthcare to discuss ways in which our Site Validation Solution may be applied to their Instrument Commissioning & Qualification Services business.
These discussions culminated in GE Healthcare licencing our Instrument-/Equipment-specific Commissioning and Qualification Templates and automation software to support their Instrument C&Q Binder business, and latterly their FlexFactory and Cell Therapeutics businesses.
Over the years we have continued to refine, optimise and build on these solutions and we are now making them available to other GxP Instrument/Equipment Manufacturers to assist them in overcoming a number of common issues:
- Current validation state is unknown
- Current validation state is not linked to critical design aspects
- An unacceptable amount of time is wasted firefighting
- Continuous improvement projects often face underfunding, lack of resources, and frequent deprioritisation
- Inconsistent test data entry
- Errors in equipment/instrument test configurations
- Customer complaints (>0.5%)
- Unnecessary Rework (>0.5%)
- Excessive binder generation times (>10 minutes)
- High binder generation costs (>£400)
- Unnecessary duplication of tests and test content
- Managing the impact of changes is complex
- Variability in GxP compliance across product ranges
- Complex, time consuming document maintenance
- Excessive review and approval times
- Excessive test execution times
- Inconsistent test execution
- Scaling the business to support highly variable sales
- Non centralised document production results in approach variation
If any of these issues outlined resonate with your challenges, we are equipped to facilitate the rapid and cost-effective implementation of proven continuous improvement solutions that can significantly enhance the quality and profitability of your C&Q operations.
Contact us to find out more: enquiries@equaserve.com
Our Products & Services
Over the years, we have systematically developed and refined proven continuous improvement services and corresponding products, specifically designed to address previously identified quality issues. Our key offerings are outlined below:
Services:
Consultancy and Implementation:
- Validation Current State Documentation
- Instrument/Equipment Validation Optimisation Assessments
- Knowledge Compilation
- Commissioing & Qualification Assessments
- Current State Documentation
- Future State Documentation
- Prioritised Mitigation Strategy (where required)
- Implementation Strategy Development
- Implementation
- Commissioning & Qualification Test Optimisation
- Modular Testing Implementation
- Shared Test Implementation
- GxP Compliance Levelling
- Deviation/Non-Compliance Optimisation
- Comment Optimisation
- Execution Optimisation
- Acceptance Criteria Design Linkage
- Acceptance Criteria Categorisation
- Protocol and Report Optimisation
- Protocol & Report Structure Modulation
- Rebranding Simplification
- Pack Configuration Rule Development
- Automated Customer Binder Generation
- Development of Integrated Equipment Product Offerings
- C&Q Policies
- C&Q Plans
- Execution Guides
- Nominated Personnel Files
- Process Risk Assessments
- C&Q Strategies
- C&Q Scope/Status Reports
Outsourcing Business:
Let our team handle the repetitive tasks. By outsourcing the generation of your C&Q Binders to us you can free your skilled resources to focus on continuous improvements, ensuring your products remain fully compliant with the requirements of the future. Our outsourcing model:
- Outsourced C&Q Binder Generation
- Provides a 24hr lead time
- Low fixed binder costs
- Protects your business from variations in order volumes
- Frees your skilled resource to focus on continuous product improvement
- Minimises customer complaints
- Maximises profit margins
Products:
Off-the-Shelf Instrument/Equipment C&Q Solution
- Full Suite of Modular Optimised Commissioning & Qualification Templates
- User Requirement Specification
- System Boundary
- Risk Assessment
- Verification Strategy
- Design Qualification (DQ)
- Factory Manufacturing Tests (leveraged)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- GAMP Tests
- Execution Guidance
- Branded to your business
- Supports customer branding & document naming conventions
- Supports bespoke customer test configurations
- Equipment SCRIBE 4.0 Automation Software
Optional software solution developed to assist in the implementation of the optimised Commissioning & Qualification Templates installed on a GxP Equipment Manufacturers site.
Contact us to find out more: enquiries@equaserve.com
Our Implementation Strategy
We understand that money, time, and resources are limited, and it can be challenging to justify large budgets for open-ended, one-off GxP compliance improvement projects.
That’s why we provide our compliance enhancement solutions as continuous consultancy-driven improvement initiatives, seamlessly integrated alongside your ongoing Equipment / Instrument Commissioning and Qualification (C&Q) test documentation production processes.
Given that our modular initiatives integrate to create a unified Validation approach, they can be implemented in various sequences while still contributing to a cohesive overall strategy.
A typical implementation includes the following activities:
- Our customers commit to investing in a few weeks of external consultancy support, during which we aim to deliver an instant and measurable return on investment.
- Our consultancy commences with the Quality / Validation Manager to prioritize our scope of work for maximum return on investment.
- During these initial meetings, we will demonstrate proven rapid implementation solutions to address the prioritised validation problems presented.
- If agreed, our proven methodologies will be implemented for a single item of Equipment / or Instrument as a proof of concept, requiring the input of limited internal resources for a minimum number of hours.
- Once optimised for a single item of equipment / or instrument the approach can then be approved for rollout across other products
- Key personnel will then be trained in the in house integration of other prioritised items of Equipment / or Instruments.
- The life-cycle solution is then seamlessly rolled out across other products as required.
- The C&Q test documentation is then continuously enhanced over time.
- Additional sub offerings are then added to the portfolio over time.
- Portions of proven production can then be outsourced as required to release internal resource for other prioritised product enhancements.
Contact us to find out more: enquiries@equaserve.com
A Foundation of Knowledge
GxP Equipment Manufacturers have several critical advantages over GxP Drug Manufacturing companies when it comes to Equipment / Instrument Commissioning and Qualification (C&Q) activities, particularly in the areas of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and Operation Qualification (OQ) to include:
- You have a detailed understanding of the Equipment Manufacturing Process
- You understand the critical aspects of the equipment and how they are impacted during manufacture, distribution, installation, commissioning and qualification
- You can perform tests that can only be completed as the equipment is built
- You understand the testing requirements for all equipment configurations (Manufacturing Tests, FAT, SAT, IQ and OQ)
- You sell large volumes of the same equipment and associated C&Q packages
- You are immediately aware of changes
- You can fully leverage manufacturing tests, FAT & SAT into the downstream IQ & OQ
We have harnessed these advantages in developing our solutions by formalising this knowledge into a usable, referenceable, and maintainable framework, which serves as the foundation for all our work.
Every decision is made with thoughtful consideration of, and in reference to, this evolving foundation, which grows over time with accumulated manufacturing expertise, regulatory advancements, and continuous improvement efforts.
Contact us to find out more: enquiries@equaserve.com