Having Queries related to IT Compliance and CSV, you have got a partner in US! Whom you can rely on!
In a regulated environment like life sciences, Food and Beverages, computer systems have a large influence on the quality of the drug and safety of the patient. Hence, these systems must be validated for data integrity according to international regulatory requirements like US FDA (Food and Drug Administration), EMEA (European Medicines Agency). The regulations from 21 CFR Part 11, and EU GMP Annex 11, Annex 15 are considered for software validation.
Our SMEs have experience in getting complex applications validated that involves ERP, Document Management Systems, Laboratory Information and Management System (LIMS), eLogBook, and other custom IT applications.
There are four ways in which you can avail our Services in Compliance & CSV
Compliance Consulting
Compliance is more than just the creation, approval and filing of SOPs and all related templates and documents.
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We analyze and design your compliance processes in IT and show you solutions for integrating them organizationally into the department. We provide you with the necessary content and tools, and we process the results in compliance-compliant SOPs.
Validation As A Service
On the basis of a service contract, our experts are available to you on demand and at short notice. You communicate the task, we plan the effort and schedule the service that you release. In this way, you retain full cost control with maximum flexibility. The service includes all common IT compliance tasks.
Validation Services
You are implementing a new system or are facing an important FDA or major customer audit. Your capacities are not sufficient to complete the upcoming tasks for the validation of the systems on time.
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We have the right and reliable resources for this, who are available to you on a temporary or long-term basis as required.
Managed Services
You take care of the IT, we take care of the regulatory compliance (Managed Validation Services). Your IT department and US work hand-in-hand across the company.
On the basis of a service contract that also guarantees a high level of confidentiality, we take on all compliance tasks that arise during the validation. To this end, we “plug in” to your change process and ensure that all compliance-relevant tasks are completed on time and in compliance with the rules.