With our unique expertise in computer validation, we can help you achieve full compliance.

Offering a complete range of services, we aim to ensure that your company can develop, validate and maintain computer systems in compliance with the latest regulations.

First-hand knowledge of complex requirements
Many of our experts work on committees that develop new approaches to computer validation. This insider perspective and know-how allows us to offer you the most comprehensive support.
 
Risk analysis for computer systems
To focus validation efforts, we prepare and chair risk assessment sessions. We offer staff training in preparing and executing risk assessment sessions and developing necessary procedures.

21 CFR Part 11
We offer all services necessary to bring your computer systems into compliance with the FDA’s requirements for Electronic Registrations and Electronic Signature (21 CFR Part 11), including training, consulting and project management.

GAMP 5
We help implement quality control systems based on Good Automation Manufacturing Practice 5 guidelines. This includes GAP analyses for GAMP 5, preparing and adapting procedures and document templates, training and supplier audits.

Our computer validation services also include:

• Development of efficient strategies for the validation of computer systems
• Preparation of requirement documents
• Preparation and execution of qualification documents
• Preparation of qualification and validation reports
• Definition of Good Engineering Practice (GEP)
• Preparation of specific working instructions (SOPs)
• Training
• Supplier audits