Bridging the GxP Gap between Quality and IT

How Effective is Your QMS?

Do you measure it? Does it need a boost or are you simply lacking one? Then we might be the people for you.

EmpowermentQE have worked to dozens of Quality Systems and know that the effectiveness of the Quality System can make or break a project.

Our GXP IT auditing service has exposed us to the Quality Systems of the major global IT Suppliers; we’ve seen a lot: some things that are good and a lot that is bad.

Our approach is not just based on theory: as engineers we worked to some great and not so great Quality Systems, so we focus on efficient process and defect prevention throughout the entire QMS.

We ensure that productivity is made more efficient by quality and not impeded by it.

Talk to Empowerment Quality Engineering if you want truly effective processes; increased throughput, happy end users, reduced operational costs and reduced risk to patient health.

Supplier and Compliance Audit Services:

Do you want a certificate of documentation compliance OR do you really want to know about the quality of your system?

Our technical know-how as software and network engineers mean that we cut through technical jargon; quickly spot gaps; identify root cause and establish effective mitigations.

This knowledge, coupled with our regulatory Computerised System expertise, provides a unique service offering to you.

Our audit offering is the result of hundreds of audits, conducted globally:

• Internal Compliance Audits.
• Computerised System/Tool Selection and Assessment.
• Supplier Audits: Bespoke software, Cloud (PaaS, IaaS, SaaS).
• Themed audits: Security, Testing, Risk Management, Change Control, Metrics.
• GDPR sub processor assessments.
• Audit preparation for suppliers.

Contact us today to find out more.

Business Analysis

Robust requirements are essential for integrity, quality and end patient health. Here are some of the areas we focus on:

• Preventative Approach: Prevent mistakes, conflicts and gaps within requirements that lead to false assumptions within technical solutions and associated defects in production.
• Critical Thinking: Challenge your business, regulatory and technical needs.
• Bespoke Approach: Use risk assessment to establish business, regulatory and technical risk mitigations that define your specific approach to your unique project.
• Inclusive Approach: Facilitate system workshops and use them to create presentations and documents that state clearly and unambiguously all requirements.
• Collaborative approach: Communicate requirements to the relevant stakeholders (including suppliers) and teams for review, update and buy in.

Contact us to learn more about our preventative approach.

Verification and Validation

Ineffective testing will result in delayed releases, increased costs, disgruntled users, poor quality and impact patient health. You may be spending a lot on your testing approach and getting a low return.

We have learnt how to correctly apply robust verification techniques that seeks to challenge the weaknesses of each IT implementation activity across the entire life-cycle. Learn how to:

• Devise an effective strategy to prevent and then detect issues earlier, when it is cheaper and safer to correct them.
• Capture and record the appropriate level of evidence of the verification activity performed to provide objective evidence AND support process effectiveness measurement.
• Use Risk to justify and define the entire scope of verification activities - even those performed by your supplier.
• Leverage the Defect Removal Efficiency approach to demonstrate the effectiveness of your strategy and to predict latent production issues.
• Apply all of the above to confidently and effectively benefit from the Computer Software Assurance approach.

To discover how to speed up testing activities AND reduce production issues, email Empowerment Quality Engineering

Training

Our training challenges delegates in how they view their role, who their internal customer are and how their actions impact on the business value add, as well as end patient health.

Examples of training provided, include:

• Quality Management.
• Establishing a Risk Based Quality Approach.
• GxP Regulations for Developers.
• Software Development Life-cycle Processes (e.g. Configuration Management, Change Control).
• Testing (Test Processes, Test Techniques, Test Roles, Test Phases, Test Tools).
• Computerised System Validation.
• Effective Team Management.

Our consultants continuously work in the field and bring with them relevant, real life examples that will empower your people. Contact our team now to discuss your training needs.

Contact EmpowermentQE to find out more.

Consultancy

We understand the complex relationships between each decision, role and activity in the software life cycle. We know that it is the aggregation of marginal gains that provides value add and improvement. Here are some of the activities we perform for clients:

• Process Improvement: Tailor proven Software and IT engineering processes to best suit your current needs.
• Effective Metric Analysis: Use metrics to baseline process, prioritise improvements and demonstrate quality of your approach.
• GDPR Assessments: Document the activities of sub processors, their gaps, and define mitigations to reduce the impact to your organisation.
• Risk Management: Everyone talks about it, yet no-one is quite sure how to do it. We do because we've done it.
• Building Security in: 75% of defects occur at the software level (Gartner). Find out how to refocus activities to building security in from the outset.
• Training: We've provided bespoke training across the IT, Software and Validation processes, across the globe.

Contact Empowerment Quality Engineering to discover if we can help you out today.