The purpose of Computer Systems Validation (CSV) is to provide an organized and consistent plan and documentation that ensures the integrity and function of a computerized system throughout its operational life cycle. Typically, full validation of computer systems is required when the system is used to generate, manipulate, store or transmit data related to a regulated product or service. All too often organizations think of validating their ELN and LIMS at the end of their project. This can cause huge delays in system delivery and has even been known to cause projects to fail.
To avoid this, an industry best practice is to include the quality team at the outset of your ELN and LIMS project in regulated environments. They will know what your organization’s ELN and LIMS validation policies are and will be critical to your project success. The first step and a critical success factor for any CSV project is to create the Validation Master Plan which will describe the validation approach including the activities, procedures and responsibilities associated with validating your ELN or LIMS.
How We Help You with ELN & LIMS Validation Planning
CSols’ ELN & LIMS Validation Practice is comprised of highly skilled scientists, laboratory informatics experts, information technologists, and regulatory experts. This multi-disciplinary team of ELN and LIMS validation consultants speaks the language of both your business and laboratory personnel. They will quickly understand your ELN and LIMS implementation, relevant applications, business and lab processes, and lab data and information workflow. Furthermore, CSols’ ELN & LIMS validation consultants also understand the real-world practices of regulatory bodies such as the FDA, EPA and NRC. CSols, therefore, can effectively and efficiently help you plan and implement a fully compliant, defensible laboratory informatics system and environment.
- ELN and/or LIMS Validation Master Plan.
Benefits From CSols ELN & LIMS Validation Planning
Our unique ELN & LIMS Validation Services portfolio combines the experience of our industry experts with CSols’ methodologies which have been refined by best practices. This proven combination has delivered peace-of-mind for our clients. Additionally, by considering the needs for ELN and LIMS validation at the outset of projects, customers who have engaged with CSols to perform their ELN & LIMS Validation Strategic Planning have greatly reduced the overall time, effort, and cost of the their ELN and/or LIMS validation projects. They have also been well prepared for and have easily passed multiple regulatory audits.
Excellence by Design™, as practiced by CSols, will instill excellence into your ELN and LIMS validation project to maximize your project success and minimize your project timeline and overall costs.
Rather Talk To Someone?
If you’d like to discuss your options and needs for LIMS or ELN Validation Planning, we’d be happy to talk one-on-one with you. Click the button to send us a message and we will have the appropriate person reach out to you.