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Comprehensive support for efficient and compliant product release
Thermo Fisher Scientific works with you from evaluation to validation, focusing on safe, rapid, and cost-effective product release. We provide services to design your lab, train staff, and implement solutions efficiently. Our experienced team guides you through regulatory requirements with comprehensive CSV documentation, supporting FDA standards for your product release.
Meeting regulatory requirements
Understanding and meeting regulatory requirements is vital in bioprocessing. Our knowledgeable team is well-versed in these regulations and can guide you through the complexities, making the process smoother and more manageable.
For example, through our Computer System Validation (CSV) service, you’ll receive comprehensive documentation to help you reduce risk and support regulatory compliance. With our support, you can confidently navigate the regulatory landscape and focus on what you do best—innovating and producing high-quality bioproducts.
Why it's important to have specialists who understand regulatory requirements
Navigating the complex landscape of regulatory requirements can be a daunting yet critical consideration in your bioprocessing workflow. Having a team that knows the ins and outs of these regulations can make all the difference in facilitating your product's release. Here are some key regulatory considerations:
This regulation applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any Agency requirements.
- 11.10(a): Computer systems should be validated to help ensure accuracy, reliability and consistent intended performance
- Guidance: Scope and application
- The approach for validation should be based on a justified and documented risk assessment and determination of the potential of the system to affect product quality, safety and record integrity
- Automated equipment should be suitable for its intended use
- All equipment should be routinely checked
Annex 11 is part of European good manufacturing practices (GMP) guidelines and defines the terms of reference for computerized systems used by organizations in the pharmaceutical industry. Annex 11 is a guideline and is key to compliance with GMP principles in European directives (regulations) covering human and veterinary medicinal products.
This refers to the good automatic manufacturing practices (GAMP) issue five document. Although this document has no legal standing and is purely advisory, it does contain information and methodologies that are of interest to anyone engaged in validation activities within the cGMP regulated environment.
- ALCOA: An acronym used in clinical research. It stands for attributable, legible, contemporaneous, original and accurate. Whether recorded on paper or electronically, source data should follow ALCOA.
- ALCOA-plus: This acronym stands for attributable, legible, contemporaneous, original and accurate, which puts additional emphasis on the attributes of being complete, consistent, enduring and available.
- Current good laboratory practices (CGLP)
- Current good clinical practices (CGCP)
- Current good manufacturing practices (CGMP)
- Current good documentation practices (CGDP)
What does this mean for you
Partner with us for comprehensive support at every stage of your journey. From the initial design of your lab to the implementation of systems that meet stringent government regulations, the Thermo Fisher Scientific pharmaceutical analytics services team is dedicated to your success. We offer expert guidance to help ensure your operations are efficient, compliant, and optimized for peak performance. With our support, you can focus on innovation and production, confident that your lab meets the highest standards.
Analytics Knowledge Hub
Explore the Analytics Knowledge Hub and discover a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize analytical testing in your bioprocess workflow.
Request a technical consultation
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Additional bioprocessing resources
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For Research Use Only. Not for use in diagnostic procedures.