How Arkivum Supports 21 CFR Part 11 Compliance for Pharma and Life Sciences

Organisations managing electronic records, particularly in the Pharma and Life Sciences sectors, must meet strict requirements when it comes to data integrity, safeguarding, and accessibility. 21 CF R Part 11 is one of the key regulations that sets a high standard for managing electronic records. Arkivum’s digital preservation solution is specifically designed to support compliance with 21 CFR Part 11, with features and tools that help organisations ensure their data is properly managed, preserved, and accessible. Below are some of the key features from Arkivum that support compliance with this important regulation. 

1. Providing Confidence with Comprehensive System Validation 

Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. (21 CFR Part 11) 

Arkivum’s digital preservation solution has been built to meet the quality standards expected by life sciences, supporting compliance and reliability. Each update undergoes rigorous testing and verification, ensuring that functionality aligns with business and regulatory requirements. To make the validation process simpler, a validation pack is provided, equipping customers with the documentation and support needed to confidently meet industry validation standards.  

2. Transparency with Audit Trails 

Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. (21 CFR Part 11) 

The Arkivum system automatically generates tamper-proof, immutable logs that capture every key activity, from record creation and modification to deletion. This ensures a secure and comprehensive history of system actions. With these detailed audit trails, organisations can confidently demonstrate compliance by providing documented evidence of data usage and changes—critical during regulatory audits by the FDA, and other regulators such as the EMA and MHRA. It is also worth noting that not all systems that are used today for archiving digital records provide comprehensive audit trails, one example being SharePoint.  

 3. Control Who Has Access 

Use of authority checks to ensure that only authorised individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. (21 CFR Part 11) 

Role-based access controls with different permissions, ensure that only authorised personnel can access your data or functions. To further align with 21 CFR Part 11, Arkivum customers also have the choice of including multi-factor authentication and single sign-on (SSO) integration. These measures not only safeguard against unauthorised access but also provide organisations with the confidence that their data is secure and compliant with regulatory standards. 

 4. Data Integrity – Peace of Mind for Inspections

The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. (21 CFR Part 11) 

Maintaining data integrity is one of the biggest strengths of Arkivum’s archiving and preservation solution. Through automated checksum validation, the platform continuously detects and prevents potential data corruption or loss, ensuring records remain intact. Once ingested, data undergoes regular automated integrity checks. Coupled with this, Arkivum stores at least two copies of the data in two geographically different locations, with an optional third “Escrow” copy for even more protection. In the rare event of data corruption, the system quickly identifies the issue, allowing the customer to replace the affected file with a clean version. These features ultimately provide confidence and peace of mind when preparing for an inspection.  

5. The Importance of Training and Awareness 

Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks (21 CFR Part 11) 

At Arkivum, we prioritise user education and compliance through comprehensive resources and continuous training. To support users, Arkivum offers a range of online materials, including user guides, release updates, and training videos. These resources are carefully managed under our internal standard operating procedures. Additionally, Arkivum’s our Quality Management System Manual outlines an ongoing training program designed to keep our staff informed and up-to-date on the latest 21 CFR Part 11 regulation updates, further reinforcing our commitment to compliance and quality. Arkivum regularly publishes free content for the Pharma and life sciences community, offering valuable guidance on critical topics. Additionally, we collaborate with organisations such as the Digital Preservation Coalition (DPC) and the Health Sciences Records and Archives Association (HSRAA) to support best practices and innovation within the industry. 

Conclusion 

In an industry where compliance is of the upmost importance, Arkivum’s digital preservation solution offers a robust and reliable pathway to achieving 21 CFR Part 11 adherence. Its advanced features from tamper-proof audit trails to digital preservation to ensure records remain readable and accessible empower organisations to manage electronic records with confidence. By using Arkivum’s digital archiving and preservation solution organisations can ensure data integrity, enhance operational efficiency, and stay ahead in a rapidly evolving regulatory landscape.