Navigating the stringent regulatory landscape of the pharmaceutical industry requires robust and compliant solutions. We specialize in offering comprehensive validation services that meet the exacting standards of US FDA 21 CFR Part 11 and EU Annex 11. These regulations are crucial for clients selling products in the European Union and the United States, demanding rigorous validation of electronic records and electronic signatures.

Complete Validation Documentation

Our services include providing complete Installation Qualification (IQ) and Operational Qualification (OQ) documentation. These critical components ensure that your systems are installed and functioning correctly, meeting all predefined requirements and specifications. Our team offers standard templates to streamline this process, but we are also flexible in adapting to your needs. If you prefer using your existing templates, our team can seamlessly work with your Computer System Validation (CSV) team to ensure all documentation aligns with your internal standards and practices.

Assistance with Performance Qualification (PQ)

We understand that Performance Qualification is a vital step in the validation process. To this end, we assist in drafting PQ-related Standard Operating Procedures (SOPs).

Customized Approach

We recognize that every pharmaceutical company has unique requirements. Therefore, our approach is highly customizable, aligning with your specific validation needs. Whether it's adapting to your SOPs or integrating with your existing validation frameworks, our goal is to ensure a smooth, compliant, and efficient validation process.

Our validation services are more than just a compliance measure; they are a commitment to maintaining the highest standards of quality and reliability in your pharmaceutical operations. With our expertise and support, you can confidently navigate the regulatory environment, focusing on delivering safe and effective products to your customers.

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