Pharmacovigilance Best Practices Part II: Consortium Initiative

In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams.

Two hands touch screen of tablet with medical icons. VectorIn order to facilitate the implementation, production and maintenance phases of a pharmacovigilance system migration project, ARITHMOS has introduced a consortium for the provision of Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of lower costs due to the sharing of set-up activities, validation documentation and deliverables. The Oracle Argus system would be released to the customer with a standard configuration which is shared among multiple end users.

The concept of sharing implementation activities guarantees at least a 20% reduction in costs for Consortium subscribers. The benefits to joining are:

  • Access to experienced Project/Account Manager during set-up and production
  • Get a standard configuration built on best standard practices and experience
  • Have the PhV application hosted in a certified Data Center with backup/recovery processes in place
  • Compliance and regulatory expertise and support during inspections
  • Use of International Standards (GAMP5) and Internal QMS
  • Multidisciplinary team covering all validation aspects (Business analysts, IT experts, CSV specialists)

Why is the Consortium an ideal solution for pharmacovigilance departments?

Step 1: Oracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. It is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Business Processing Services (BPS) provider, ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee.

Step 2: The Consortium initiative also covers compliance and Computer System Validation aspects of pharmacovigilance through a Quality by Design approach. As a member of the Consortium, a cross-functional team of validation experts are available to make sure the system is maintained properly through periodic review and change control.

Consortium ROI: Consortium membership guarantees cost reduction through the sharing of implementation activities and documentation. However, the real Return on Investment comes from access to validation experts, advice and feedback from other Consortium members and access to “My Oracle”, which is Oracle’s official web portal for the support of its applications – guaranteeing a smooth, compliant and risk free pharmacovigilance process.

The Consortium is a yearly initiative with limited subscriptions available. For more information on a pharmacovigilance system migration project and Consortium membership, contact ARITHMOS at





Pharmacovigilance Practices Part I: Argus Data Migration

In this two-part blog, ARITHMOS takes an extract from its article series on migrating safety data and cases from legacy pharmacovigilance systems to Oracle Argus. ARITHMOS describes the process involved in data migration and validation principles and considerations during the production phase to ensure efficient and cost-effective pharmacovigilance practices. In Part II of this blog, coming next week, ARITHMOS will discuss what happens after migration and how joining its consortium initiative can result in considerable cost savings.

Oracle AERS premium support will end in 2015, and various other pharmacovigilance systems offer limited support. Therefore, ARITHMOS recommends a data migration project to Oracle Argus Safety, which is an up-to-date pharmacovigilance sytsem that meets all the requirements of computerized systems in the GVP environment.

Hand press on First Aid Symbol , medical background

How would an implementation project work?

As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety Version 7 license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migration includes:

  • Business Requirements Analysis
  • Configuration Analysis
  • GVP Validation Assessment
  • Detailed User Requirements definition (including configuration workshop)
  • Data Migration strategy
  • Configuration set-up and pilot testing system design specifications
  • Design, Build and Test Data Migration solution
  • System Installation
  • Validation Testing (IQ, OQ) and Business QC of migrated data
  • End Users training and User documentation
  • Validation Testing (PQP) and Production Data Load
  • Validation Report

This process can take an estimated 6-8 months to complete, therefore if a legacy system is still in place in your company, it is best to begin the migration process.

Due to increased regulations on safety data and the need to improve data quality, ARITHMOS can guarantee real-time reporting solutions for Oracle Argus Safety Version 7 including integration with Oracle Business Intelligence with reports directly on smartphones and tablets.

Validation Principles and Best Practices

The data migration progress guarantees:

  • Risk Based Approach
  • Proactive validation
  • Use of international standards (GAMP 5) and Internal QMS
  • Use of templates and validation scripts
  • Monitoring and control over the project
  • Multidisciplinary project team covering the key aspects of validation (business analysts, IT experts, CSV & QA specialist)

A dedicated Account Manager will provide support during the production phase including operational technical support, user access management, periodic review and support in preparation and conduction of regulatory inspections. ARITHMOS can also support in the decommissioning of the legacy pharmacovigilance system.

argus safetyIn Part II, ARITHMOS will explore what happens after data migration and how companies can properly maintain their pharmacovigilance system. If your company is considering a migration project from a legacy system to Oracle Argus Safety Version 7, schedule an assessment meeting with ARITHMOS to learn your business and user requirements.

FDA 483s & Warning Letters and How to Avoid Them

computer_warningThis week ARITHMOS has been focusing on Computer System Validation and the importance of implementing a proactive approach to system validation and maintenance. In this week’s blog post, we look at FDA warning letters, what they mean and how to avoid them by following the computer system validation life cycle.

Warning Letters represent two of the three steps that are important to a GxP assessment of deviations.

  • The first step are deviations reported on the well-known FDA-483 Form by an FDA inspector at the time of inspection.
  • A Warning Letter is issued if the EIR (Establishment Inspection Report) written by the inspector has been checked by the head office and the deviations have been classified as significant or the statement on the elimination of the faults has been classified as insufficient.

If the answer to the Warning Letter is also insufficient from the FDA’s point of view, they enforce step three:

  • The inspected site cannot manufacture products for the US/American market until further notice

What are the most notable deviations that result in FDA-483 forms and Warning Letters?

  • No individual passwords which can cause repudiation problems
  • Insufficient system security
  • No electronic audit trail
  • (Electronic) raw data not saved or lost
  • No correlation between e-records and paper print-outs
  • No back-up of data
  • No prevention of data deterioration during archiving
  • Lack of or inadequate computer system validation

Implementing a CSV Plan to Avoid FDA-483s and Warning Letters

Sponsors can avoid the deviations above by performing a risk assessment on their computerized systems and then maintaining system performance through periodic reviews and change control. The Computer System Validation life cycle follows a process that tests systems throughout the Software Development Life Cycle (SDLC).

For example, let’s look at the requirements for Electronic Records and Electronic Signatures (ERES). ERES requirements are related to the validation of the system and maintaining the system in a validated state. Inspectors will look at a combination of technical controls provided by the system and procedural controls provided by users or administrators of the system.

Therefore, how can Sponsors approach CSV?

  • Planning and Requirements: Validation should cover both technical solutions and the implementation of any procedural controls for electronic records and signatures. Define compliance requirements, create a validation plan and define user requirements.
  • From Designing to Deployment: Design and build requirements, perform development testing  and deploy the system to satisfy all user requirements
  • “In Use”: Provide training, define a security procedure in a System Access Plan, retain records according to their retention period and record copies which need to be provided during inspections.
  • Cross Phase: Ensure that anyone who develops and maintains systems has the education, training and experience to perform the tasks at hand. An appropriate Document Management Plan should also be defined including a maintenance plan according to change control. Also ensure that a Change Management Process is in place to maintain the validation status.
  • Decommissioning: Systems should be decommissioned in accordance with a Decommissioning Plan. Validation documentation must be archived and data maintained in according to the retention period. Even if the system is decommissioned, it must be guaranteed that copies of records are available during inspection.

The FDA requires that organizations comply with all applicable regulatory validation requirements including validation of design, computer software for its intended use and software changes before approval and issuance. Contact ARITHMOS to discuss or strategic and maintenance approach towards CSV and our expert advice on how to avoid FDA (and other regulatory bodies) Warning Letters.