C-realize solutions for FDA 21 CFR Part 11 Compliance

C-realize helps companies in the life science industry and their suppliers with plans, guidelines, checklists to setup a Software Development Lifecycle (SDLC) which ensures compliance with FDA 21 CFR Part 11 as well as EU GMP Annex 11.

Its Part 11 and Annex 11 compliance solutions are also optimized for modern agile software development methodologies.

Annex 11 and Part 11 summary

Title 21 CFR Part 11 is a key element of the US Food and Drug Administration (FDA) regulatory regime that establishes the ground rules for using IT in pharma processes,., including electronic records and signatures. These aim to construct a framework that ensures the integrity, authenticity, and reliability of electronic records and signatures used in life sciences activities.

The scope of Part 11 encompasses the digitalized and automated dimensions of all life sciences activities governed by the FDA, particularly Good Manufacturing Practice (GMP) guidelines, and therefore forms a cornerstone of the GMP regulations. Part 11 requirements apply to any Life Science organization that uses IT systems for record keeping and approving processes for products marketed in North America.

Similarly Annex 11 is a guideline formulated by the European Medicines Agency (EMA) of the European Union (EU) for using computerized systems in GMP-regulated activities, including pharma, biotech, contract drug manufacturing and medical devices.

Differences in Annex 11 and Part 11 requirements

Both guidelines specify requirements for implementing and validating computerized systems to ensure data security and integrity in GMP-related activities.

However, they come from different basic standpoints, apart from their geographic and market applicability, one key difference between the two regimes is that 21 CFR Part 11 provides a list of specific requirements that must be met, while EU GMP Annex 11 provides more general guidance to help pharma manufacturers assess and implement necessary controls to minimize risks and identify vulnerabilities.

Further, EU GMP Annex 11 takes a more holistic approach that considers the whole computerized system while 21 CFR part 11 is primarily applicable to electronic records and signatures.

21 CFR Part 11 audit trail requirements and risk assessment

21 CFR Part 11 places greater emphasis on comprehensive audit trail implementation, requiring trails for all electronic records across the whole range of product data. In contrast, Annex 11 requires audit trails only for GMP-specific data.

Regarding risk management, EU GMP Annex 11 specifies that risk assessment should cover the whole lifecycle of the IT system, considering data integrity in the overall contexts of product quality and pharmacovigilance. Here, 21 CFR Part 11 is less demanding in not explicitly requiring a formal risk assessment process, nor proactive risk identification. However, these aspects are basic ‘good housekeeping’ for any IT system. And should not be ignored.

C-realize EU GMP Annex 11 and 21 CFR Part 11 validation solutions

C-realize solutions for 21 CFR Part 11 validation and EU GMP Annex 11 systems compliance are delivered as part of a suite of overall computer systems validation (CSV) tools and methodologies tailored to IT systems used in the development, manufacturing and lifecycle management of all regulated medical products.

At the same time, these service packages recognize the needs of the life sciences industries for technological expertise to cope with the fast pace of innovations and increasing digitalization.

C-realize can validate new and legacy IT systems to comply with FDA Part11 and/or EMA Annex11 regulatory guidelines, supporting clients through all phases of the development life cycle and constructing a validation package that meets the requirements of auditors and inspectors.

C-realize holds certification in Computer Validation Management by the European Compliance Academy and membership to the ISPE International Society for Pharmaceutical Engineering.

It can meet all requirements of relevant life science regulations and quality standards, including GxP regulations, 21 CFR part 11 electronic signatures and electronic records requirements, EU GMP Annex 11: Computerized Systems requirements, as well as ISO 9001, and ISO 27001 standards.

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C-realize provide help and support for all your Pharma, Biotech and Medical Devices needs in software development, cloud computing services and regulatory compliance advice and solutions, to learn more please book in a Introductory Consultation Session.