PRaaS:
Periodic review of computerized systems for the Pharmaceutical Sector
What is PRaaS?
PRaaS is our periodic review service, which ensures the ongoing quality and regulatory compliance of your IT systems with specialised periodic reviews, from drug development to post-marketing.
Importance of Periodic Reviews in GxP Environments
In the pharmaceutical industry, maintaining computerized systems in compliance with current regulations is essential to ensure product quality and safety. Periodic reviews confirm that systems meet regulations such as EU Annex 11 and FDA 21 CFR Part 11, helping prevent regulatory sanctions and ensuring data integrity.
Benefits of Implementing PRaaS
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Ongoing regulatory compliance
Keep your systems aligned with the most stringent standards in the pharmaceutical industry.
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Resource optimization
Our team of experts handles all review activities, allowing you to focus on your business’s core priorities.
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Tailored adaptation
We provide customized solutions based on your company’s specific needs, ensuring efficient and effective integration.
Ensure the regulatory compliance and integrity of your computerized systems with PRaaS from Ambit Iberia—your specialized service for periodic reviews in the pharmaceutical sector.
Who is PRaaS for?
PRaaS is designed for a range of organizations operating under GxP regulations, including:
- Contract Research Organizations (CROs)
Ensuring control and accuracy in the management of critical clinical and non-clinical trial data. - Drug and API manufacturers
Supporting product quality and safety through continuous system validation and periodic reviews. - Pharmaceutical storage and distribution companies
Preserving the integrity of inventory and distribution data throughout the supply chain.
