A Range Of
GxP
PROFESSIONAL
SERVICES
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At Digiform Solutions, we specialize in providing comprehensive GxP professional services to ensure your business meets the highest standards of regulatory compliance. From identifying and addressing compliance gaps to executing software validation, we deliver solutions that enhance operational efficiency while keeping you audit-ready.
We specialize in supporting the industry-leading platform MasterControl, helping you leverage technology to simplify compliance and streamline your quality management processes. We're also actively monitoring the FDA's guidance on use of AI in GMP systems. Whether you’re optimizing or upgrading existing systems or implementing new solutions, Digiform Solutions ensures every step aligns with your regulatory requirements and business objectives.
MasterControl
Services
Digiform Solutions provides expert, comprehensive guidance and support for MasterControl. Whether you're looking to improve, upgrade or expand your current system, or you're implementing MasterControl for the first time, Digiform provides expertise and staff augmentation to ensure seamless integration and optimal functionality.
Our services include:
Project planning and management for your MasterControl implementation or upgrade.
Staff augmentation both within the project and for surrounding activities such as validation and quality system updates.
Business analysis for effective requirements gathering and optimizing application configuration.
Staff training and materials.
Hypercare for ongoing support.
integration into MasterControl, including API creation.
The value: We collaborate with you to drive efficient, effective organizational adoption of MasterControl, whether as a new system or an upgraded one.
Software
Validation
Digiform Solutions specializes in validating software systems to ensure compliance with regulatory standards. Whether you need assistance with validation procedures, or you have an established process in place, Digiform Solutions provides expertise in completing and maintaining validated systems.
Our services include:
Validation planning
Writing and execution of test scripts
Risk-based analysis of requirements for risk-based testing strategies
Authoring and review of validation processes and procedures
Systems of focus include electronic document management systems (EDMS) and Lifecycle Management Systems (LMS)
The value: Your business remains audit-ready with validation packages at-hand for your electronic systems.
Quality Systems Consulting
Preparing for a regulatory audit or inspection can be daunting, but Digiform Solutions provides QMS staff augmentation to enhance your existing Quality Management System.
Our services include:
Quality System audits and gap analyses
Quality System optimization
Staff augmentation for your quality system
The value: We work closely with your team to implement effective solutions, mitigate risks, and optimize processes, providing the expertise needed to ensure your system is fully prepared for regulatory inspections
Book an Appointment
Book an appointment now to kick start the journey of AI transformation for your business.