GxP Compliant Archive for the Pharmaceutical Industry
Creating Certainty in Pharma & Life Sciences
Arkivum is the SaaS solution for data preservation in life sciences and pharma. We future-proof the past so you can focus on the present. That’s the power of certainty.
Data Retention: Compliance Without Complexity
It is important for pharmaceutical and life science organisations to adhere to GxP data retention regulations and guidelines. Failure to comply can result in major repercussions including;
- Operational or manufacturing delays
- Reputational damage
- Financial penalties and fines
- Invalidation of research findings
Complying does not have to be complex. By implementing robust long-term data management practices that adhere to regulatory requirements and uphold best practice guidelines, organisations can mitigate risks and preserve the credibility of their GxP data.
It was also important for Cerevel to comply with EU clinical trial regulation (i.e., EU Regulation 536/2014) around data retention, despite being located within the U.S. This relatively recent update (came in effect in January 2022) to EU regulation stipulates more stringent retention requirements and in turn, has become to be seen by many as a gold standard to adhere to.
Cerevel Therapeutics
A GxP Compliant Solution for Pharma Data Preservation
Arkivum supports life sciences organisations across a range of different use cases. Listed below are just some that we support. Click on the links below to find out more
eTMF and Clinical Data
After a clinical trial concludes, it is crucial to archive all records and data effectively and in compliance with regulations and guidelines such as ALCOA+. For instance, EU CTR states that your eTMF must be accessible and legible for 25 years or longer.
Laboratories
Handling large volumes of GLP data can present considerable challenges for laboratories, especially as data volumes rise daily. One example of this challenge is accessing data spread across multiple locations, this not only hinders the ability to revisit past data but also creates complications during inspections.
Medical Devices
Navigating regulations concerning medical device records and documentation can pose significant challenges due to complex retention requirements e.g MDR 745. To support this, medical device manufacturers need a centralised document management system that not only preserves crucial records and documentation but also supports retention requirements.
Safeguarding GxP data and records for their entire lifecycle
Safeguarding GxP data is critical for life sciences and pharmaceutical organisations, especially when data is needed to be retained for more than 5 years. Traditional physical storage such as hard drives, CDs, and USBs, as well as cloud file-sharing platforms like SharePoint and Dropbox, lack adequate protection against data corruption and loss. These tools are not specifically designed for archiving purposes.
To ensure the long-term integrity and accessibility of your GxP data, it is essential to implement robust preservation and safeguarding measures that go beyond data storage. This not only enables pharma and life science organisations to review and use complete historical data, it also instils confidence that the organisation is fully prepared for an inspection.
The Arkivum digital archive and preservation solution
Arkivum supports pharmaceutical and life sciences organisations with long-term data retention and archiving requirements.
Our solution provides the certainty for customers that their valuable digital content is searchable, accessible, and usable, forever.
Read more about Arkivum’s archiving and preservation solution
Pharma and Life Sciences Data FAQs
What validation testing do you do?
Arkivum conducts computer system validation (CSV) which includes testing and confirming that the Arkivum solution meets documented security requirements. Arkivum also conducts penetration testing on the solution.
What validation documentation do you provide?
Where required, Arkivum provides a validation pack (which includes a requirements traceability matrix, test plan, test scripts, and validation summary report), a 21 CFR Part 11 compliance assessment, a penetration testing report, and the impact assessment for GxP Data Integrity, Confidentiality, Privacy.
Are you certified in any ISO standards?
Do Arkivum allow customers to audit its business and operation practices?
Yes, Arkivum welcomes customer audits if required.
How does the Arkivum solution support inspection readiness?
The Arkivum solution is live archive, not a locked system. This means that data can be easily accessed and searched, enabling life sciences organisations to easily make requested data available. In some instances, customers may even want to provide inspectors with a bespoke login, enabling them to review and search relevant documentation as required.
In addition to this, by maintaining all of your long-term and quality checked records and data in a single repository, customers can have peace of mind that is it both inspection prepared and inspection ready.
Do you support digitization of GxP paper records and documents?
No, Arkivum does not support the digitization of paper records and documents. If this is a requirement, we have several partners who could support this process.
If you are interested in finding more, please contact us here.
You have referenced digital preservation good practice. Where does this come from?
Arkivum is an active member of the digital preservation community. A large part of this is in working and collaborating with organisations such as the Digital Preservation Coalition (DPC) and the National Data Stewardship Alliance (NDSA).
These organisations help to promote and develop digital preservation good practices for the overall betterment of the discipline.
Where is my data stored?
The Arkivum solution is hosted on Amazon Web Services (AWS). We typically store customers’ data in a minimum of two separate geographic locations, aligned with a customer’s data sovereignty requirements. An optional third escrow copy can be stored with Microsoft Azure if required.
How do I know if my data has become corrupted?
Whenever a data integrity check is conducted (called a fixity check), the system uses a checksum to compare each to how the original looked when it entered the archive. The results of these checks (including any errors) are reported within the fixity report within the system.
What security do you have in place to protect my data?
Arkivum provides a secure software solution that is hosted in AWS. All users are required to authenticate, either using local accounts or via SSO integration, which can support Azure AD, Okta and a range of other SAML2 or OpenID Connect options. MFA is supported for local accounts or via SSO integration.
All users are also assigned to roles and groups that authorise what data they can access, what functionality they can use, and whether their actions such as ingest, export or deletion require approval by other users before they are executed.
The solution is deployed in AWS and follows AWS security best practices, for example by using VPNs, Security Groups, Load Balancers and firewalls to partition the solution and control access.
Security is an integral part of Arkivum’s Software Development Life Cycle (SDLC) and is included in Arkivum’s ISO 27001 and 9001 policies and procedures (SoPs) within our Quality
Management System (QMS). This includes security by design, internal peer review, automated code analysis, Computerised Systems Validation (CSV) that the software solution meets security requirements and regular penetration testing.
Arkivum’s approach to security is audited regularly (ISO 27001, 9001 and GxP audits by customers).
Please contact us for more information.