Computer System Validation

Decades of Knowledge in Systems and Regulations

As a key component of our computer system validation process, we take time to gain an in-depth understanding of your quality management system and validation program to ensure GMP compliance for your business. We also leverage our product and process understanding to deliver validation plans and summary reports to define a cost-effective commissioning, qualification, and validation strategy. Our risk-based approach to verification protocol development and execution ensures your business receives a well-functioning computerized system with validation packages that can still be readily understood years later. Through decades of knowledge and a deep understanding of computerized systems and regulations, we are able to successfully coordinate and deliver initial and functional risk assessments for your business.

Expertise

Change Management

Change control management requires in-depth knowledge of your quality management system and validation program to ensure GMP compliance for your business. We specialize in helping define your planning and actions to successfully create and close change control records, including supporting processes such as document life cycle management.

Validation Planning and Reporting

Using product and process understanding with a risk-based approach to validation with guidance from ISPE GAMP 5, we deliver validation plans and summary reports to define a cost-effective commissioning, qualification, and validation strategy while meeting the intense demands of GMP regulations.

User Requirements and Specifications

With our extensive experience in computerized systems and process automation, we can deliver user requirements specification (URS), functional specification (FS), and design specification (DS) documents authored with traceability and maintainability throughout your system's life cycle.

Risk Assessments

Knowledge and understanding of computerized systems and regulations, such as 21 CFR Part 11, ensure our team can successfully coordinate and deliver initial and functional risk assessments. This allows your projects to adapt and deliver controls for increased compliance and resiliency.

Protocol Development and Execution

Commissioning and qualification protocols developed with your systems in mind are critical to a successful verification process at all points during a system's life cycle. Our risk-based approach to verification protocol development and execution will deliver to your business a well-functioning computerized system with validation packages which can be understood years later.

Traceability Matrixes

Building a cohesive validation package which maintains documented and accurate traceability throughout a system life cycle is frequently a challenge for GMP compliance. We combine an experienced approach to designing your validation package to ensure traceability is straightforward and robust as your system changes and grows.

Why Excel Engineering?

Excel is an experienced, dedicated partner that brings a detail-oriented and relationship-driven approach to every project to ensure it exceeds your goals. Here are just a few of the reasons to partner with us for your computer system validation needs.

1
End-to-End Support
2
Project Planning & Cost Analysis
3
Hands-On Project Management
4
Services for Remodels, Expansions, & New Construction
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Deep Technical Knowledge
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One-on-One Partnership