March 27, 2012

Know Your IT Systems Vendors

Posted in Cloud, Computer Validation, IT, Vendor Audits tagged , , , , , , , , , , , at 9:38 AM by Solutions2Projects, LLC

IT systems and infrastructure are critical to any organization.  This is especially true for life sciences companies selecting and implementing IT systems critical to the business functions supporting compliance functions. Regulatory bodies expect life sciences companies to demonstrate control over these elements regardless of whether they are the ones developing or maintaining the IT systems (infrastructure, software, etc.).

Companies cannot simply toss the responsibility over the fence to the vendors. Life sciences companies are still responsible for the integrity of the data and control over the systems.  They may delegate but only after verifying the vendor can meet the compliance and control requirements. 

This is where vendor audits come in to play. 

Vendor audits for software are not new.  Over the past decade I’ve seen the importance of vendor audits for software wax and wane and wax again.  In light of the increase in cloud and hosted solutions chosen by companies to decrease overall spend, the need for vendor audits is critical.

And, as biotechs become more virtual and more services are outsourced (CRO, CMO, data management, complaint handling, etc.), it is imperative that companies verify their vendors meet compliance requirements as well as their own procedural and process requirements.   The vendor’s IT systems and controls must meet the requirements as if they were hosted by your own company.  Not all vendors perceive the need to meet compliance requirements at the same level and you need to know before you enter any agreements.  Once you’ve signed the contracts, you’ve lost your leverage for process improvements and controls. 

Why conduct the audits? 

  • Gain high level of confidence that the computerized system will meet technical, commercial and regulatory requirements (GAMP 5)
  • Confirm the supplier builds quality and integrity into the software product during development
  • Leverage knowledge, experience and documentation of supplier (GAMP 5) to potentially reduce validation effort
  • Confirm processes and controls when  outsourcing IT / software functions (SaaS, PaaS, IaaS, hosted solutions, co-locations)

When should audits be performed?

  • For high risk systems / outsourced services
  • Before any contracts are signed!
  • Scheduled follow up audits based on
    • Audit results
    • External audit program
    • Risk assessment
    • Significant vendor business changes
    • When there are issues with the vendor

How are audits performed?

  • Similar to other vendor audits for CMOs or other critical suppliers
  • Plan for the audit and communicate expectations to the vendor
  • Conduct the on-site audit (for IT systems, Quality and IT representatives should participate)
  • Summarize findings with the vendor at the end of the audit
  • Document findings in an audit report and provide to the vendor for a response
  • Follow up on observations and document

The financial cost of, and risk associated with, software solutions has increased exponentially which means that it is imperative for organizations to understand what they are getting into before they sign on the dotted line.  The cost of a software or IT system blunder can be expensive in terms of resources, time and can make or break a life sciences company.  If you cannot demonstrate control, and therefore the integrity of your data, for systems supporting drug product administered to patients, a regulatory body may not grant approval for your product or could shut down manufacturing operations.  Your company owns the data and the responsibility even if it service is outsourced. 

Knowing your IT vendors gives you the knowledge to reduce the risks associated with the IT solutions in your life sciences company.  Without this knowledge, you are powerless to defend your risk assessment and risk mitigation strategy to regulatory agencies.

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January 30, 2012

IT Policies to Establish Control

Posted in IT tagged , , , , , at 7:33 AM by Solutions2Projects, LLC

When we at Solutions2Projects are brought into a biotech or medical device company to work for the first time, it is usually to provide selection or implementation services for the first big IT project.  The companies are usually positioning themselves for an IPO and need greater control over their financial transactions or are preparing for commercialization and therefore need a system for inventory management or manufacturing.  In both cases, the companies need policies and procedures for managing these systems once in place. 

 Over the years we have identified the following as the minimum policies that need to be in place once the system is released into production.  If the system is a GxP system and is being validated, the policies are verified as part of the validation process. 

  • Change control / change management
  • Operation and maintenance
  • Security
  • Passwords
  • Backup and restoration
  • Deviation management

 Having these policies in place (and adhering to them) provides IT personnel, affected system users, and business owners with a foundation for control.  For GxP systems, FDA has been known to hand out 483’s for GxP systems that were not controlled from inception.  Think about it.  If you are basing a submission on data from a system that was not under control from inception, how can you demonstrate data integrity and data reliability?  Getting the systems under control from the beginning reduces the system and data integrity risks. 

 Of course, the policies need to be followed.  There’s no point in creating policies and ignoring them.  IT needs to embrace these policies to be successful.  Getting IT involved in the generation and release of these policies increases the likelihood of adoption and success. And the policies need to be in a centralized location for all affected personnel to access (not just IT).  This is generally handled by Quality Assurance (QA) as they are used to document management.  If a training program is in place for GxP documents, these should be incorporated into the training program as well.  

 For each system, there will be procedures to define how the policy requirements are met.  A few examples include

  • the periodic review of users and access
  • instructions for performing test restorations and verifications
  • periodic maintenance activities for the system (technical, application)
  • periodic review of failed logins

 Each system will require different instructions for accessing the data or performing the tasks.  The procedures or work instructions allow the IT personnel to focus on the data or value-added activity and not struggle with how to get the data or perform the task.  This is especially true for activities that are performed infrequently, like annual restoration tests. 

 The policies and procedures can be expanded on over time.  Initially, enough details need to be included to meet compliance requirements and provide affected personnel with guidance to achieve the desired level of control. 

 I understand that ‘control’ is a four letter word to a lot of IT folks.  But, control reduces risk and increases data integrity and reliability, which is what IT is tasked with ensuring.  Compliance (SOX, GxP) mandates establishing control over these systems, and policies and procedures are one of the tools companies can use to satisfy the requirement.