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Engineering Process Compliance & Productivity Improvement: Learn industry best practices.

Many companies have requested our services to evaluate their development practices for not only compliance but also alignment with industry best practice. As a result we have prepared numerous improvement plans and inspection checklists that guide companies on a path to become best in class. In these consultation efforts we do not attempt to re-define your development practices but instead we tailor your practices to focus on the key elements that will eliminate regulatory risk while reducing development times and maintaining focus on product quality.

LIMS & ERP Validations:

We can show you how risk based strategies can reduce implementation and maintenance costs.

Validation of Laboratory Information Management Systems (LIMS) and Enterprise Resource Planning (ERP) systems consume significant resources and often do not result in the reduced compliance risk planned. We have performed validation of numerous LIMS and ERP systems and often are asked to audit validations performed internally. As a result of this experience we are familiar with strategies that eliminate compliance risk and minimize the effort required for initial validation and ongoing maintenance. If you are struggling with validation of a LIMS or ERP system, give us a call. We can offer checklists, sample plans and procedures, personnel, or specifications that can aid in simplifying your existing projects.

Manufacturing Process & Software Validation for Pharmaceutical Companies:

We can offer significant expertise for the validation of manufacturing processes and software systems.

Our expertise includes the preparation of validation procedures, specifications, protocols, execution of protocols, and preparation of validation reports.

Our clients have realized significantly reduced validation costs and schedules for the following reasons:

  • Use of our risk based assessment methods that focuses validation efforts on critical control points.
  • Use of our templates, guidelines, and procedures that improve productivity and ensure completeness of documentation.
  • Our expert knowledge of manufacturing process as well as software validation requirements supports optimal integration of these activities to reduce duplication and substantiate compliance.
  • Our coverage of Part 11 requirements ensures that all compliance concerns are addressed.
  • If you need assistance in optimizing your validation activities or just need additional resources to address a backlog of validation tasks we can provide expert and highly productive support services that eliminate your compliance concerns.

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