Ongoing Computer System Validation (CSV) / Computer System Assurance (CSA) activities are critical in biopharma to ensure that GxP systems remain fit for intended use throughout their lifecycle. Maintaining compliance while supporting the ongoing development of new functionality is vital to an organization.  

As biopharma and biotech companies grow and evolve, the focus of CSV/CSA efforts may concentrate on the planning or validation of new systems or major upgrades to support the growth of the organization. This can make it more difficult to sustain focus on maintenance activities of the existing business systems in your IT systems landscape – or in the case of lean organizations, resourcing challenges to support both project work and business as usual operations (planned and unplanned). 

While Application Managed Services (AMS) is typically used to help support configuration changes to a specific system as a company evolves, Managed Services for CSV or CSA is able to support the validation activities of the many systems throughout a company’s life.  

A CSV Managed Services partner can provide relief to your internal team by helping to prepare key validation activities and tasks, allowing you to focus on when and where you are needed most. 

Benefits of Validation Managed Services 

#1

Periodic reviews help confirm that systems (including ERP GxP modules, LIMS, MES, eQMS) remain in a validated state by assessing a number of factors, including Quality Events (QE) directly related to the functionality of the system. Access controls and user access reviews ensure users have the correct permissions, and you can audit trail integrity through the life of the system. One of the best uses of periodic reviews is identifying opportunities for remediation before they become compliance risks. 

Having dedicated validation services individuals on your team can mean having a fresh pair of eyes when examining periodic review content. It is often the case that organizations utilize System Owners for QE examinations during periodic reviews. CSV Managed Services individuals may be able to help identify related QEs or audit trail events in the system that were not initially examined. CSV Managed Services involvement also removes the burden of work from the system owners.  

#2

Validation support for system upgrades, patches, and configuration changes to existing business systems ensures that enhancements or vendor-driven updates do not compromise functionality and compliance. In a GxP environment, even minor system changes, such as configuration adjustments, can introduce unintended impacts to validated functionality or data integrity. Validation Managed Services support can help proactively evaluate the appropriate actions for any change to a system, including determining the appropriate level of testing and making updates to lifecycle documentation that confirm that critical requirements continue to be met. 

With the number of systems that in-house quality and validation stakeholders are dealing with, it can be beneficial to have a CSV partner producing the initial, and thorough, drafts of lifecycle documentation and test scripts. This can help reduce bottlenecks, such as with individuals who may be involved in many upgrades.  

#3

CSV Managed Services support can be especially useful when evaluating and implementing vendor-driven updates, particularly in IT environments with cloud-hosted or SaaS platforms where scheduled releases can happen multiple times a year. These often occur on defined release cycles, requiring proactive planning and coordination between different teams.  

A validation managed services provider can be used to coordinate logistics between the involved parties, such as IT, Quality, and Business System Owners. Validation support in these cases may include reviewing release notes, assessing new or modified functionality that would benefit the business or process, challenging vendor documentation where appropriate, and ensuring that testing evidence adequately demonstrates continued control of GxP-related processes. 

CSV Managed Services: Worth the Investment 

Engaging outside support may seem challenging, in areas such as ensuring the validation managed services team is familiar with your systems and procedures and is up to speed on upgrade roadmaps. However, the initial time investment, combined with proactively aligning on your responsibilities and your validation managed services partner responsibilities, leads to an effective validation function that supports your business and ensures system compliance throughout its lifecycle.  

Whether your CSV/CSA function is a team of one or a team of many, a validation managed services partner can be a valuable investment to help focus your team’s energy on the most strategic initiatives and projects for the year.  

Together, these ongoing CSV activities reduce regulatory risk, support inspection readiness, and reinforce patient safety by maintaining confidence in the systems that manage and report quality and manufacturing data.