Validation Strategic Planning

All too often, failure to plan for computer system validation (CSV) causes massive IT project delays. It is much easier to document and prove fit-for-purpose and data integrity if you plan validation before beginning LIMS, ELN, LES, or CDS implementations. Whether you have an enterprise-wide validation program in place or you need to create a validation program, CSols can reduce project risks and delays.

CSols’s validation consultants understand the real-world practices of regulatory bodies such as the FDA, MHRA, and Health Canada and can tailor a full validation program to your specific needs.

Our unique validation services portfolio combines the experience of our industry experts with proven industry best practices. This proven combination has delivered peace-of-mind for our clients, including:

• Strategic planning recommendations and guidance
• Validation program assessment
• Validation program development
• Validation program documentation
• Validation program training
• Validation master plan development
• Assessment of existing implementation and validation plans
• Quality policies and program governance assessment
• Policy and governance plan development
• Standard operating procedure development

CSols can support your validation program for fully compliant and defensible laboratory informatics systems.