Understanding how to effectively incorporate CSV requirements into your project phases and ensuring that these requirements are being followed will help teams deliver high-quality deliverables. CSV team members integrated as part of the core team can provide guidance to phase relevant CSV requirements to the team throughout the project and check their completion, thus, ensuring Quality Assurance.
We would like to give you our real client experience on how to effectively build CSV awareness throughout your project while practically binding CSV members into your teams and the benefits that come with it.
1. What is CSV?
Computer System Validation (CSV) is a mandatory requirement by quality management and has been around for over 20 years. It was put in place when the FDA introduced regulation 21 CFR Part 11 (Electronic Records; Electronic Signatures), making this a mandatory regulatory requirement.
In addition to the quality guidelines within the pharmaceutical industry like GxP (Good Practices) in manufacturing, clinical or laboratory, the primary purpose of CSV is to provide documented evidence that a computerized system performs as intended.
The CSV lifecycle can differ from company to company depending on industry-specific laws, regulations and guidelines and/or company-specific policies, directives and Standard Operating Procedures (SOP). But ultimately the CSV lifecycle can be captured by following the V-Model:
Benefits of CSV
Computer System Validation covers the following elements in an operating environment: hardware and firmware, software, additional equipment or tools, documentation (SOPs, Manuals) and users (training needs, execution and training record management). Considering all the strict regulatory requirements, CSV provides the following benefits:
- Accuracy to check output against predetermined expected results
- Security to ensure data integrity
- Reliability due to less system downtime and fixes
- Consistency to ensure consistent quality output from the computerized system
- Cost Reduction due to early detection of bugs and system failures
Risk-Based Approach in CSV
A risk-based approach offers the chance for organizations to integrate risk management with business method improvement while reducing compliance costs. As opposed to the traditional validation approach where everything needs to be validated, the risk-based approach identifies key risk areas where efforts can be focused.
When introducing new tools into your organization, a System Risk Assessment (SRA) should be conducted to assess the risk and associated mitigation processes. The SRA determines whether a more in-depth investigation is required and thus whether a Functional Risk Assessment (FRA) is necessary. The FRA determines the GxP criticality (impact on the patient: Low, Medium, High) as well as the Business criticality (impact on the business process: Low, Medium, High). Depending on these two assessments, the testing rigour and validation effort can be targeted.
2. Encourage CSV Awareness within Projects
It is imperative that all the CSV requirements are known to all the project members. This can be a challenge in large-scale transformation programs. When the requirements are clear and well understood, teams can prioritize their tasks and effectively work towards their completion, mitigating risk for project delays while ensuring resources are being used effectively. Below we have collected a few methods organizations can use to increase awareness to CSV requirements in their transformation projects:
- Interactive Video Training greatly enhances participation as it keeps the user engaged throughout the whole session. Interactive sessions can be created with emphasis on the different roles/functions of the users as well as the different project phases.
- Virtual Classroom Training are live sessions moderated by the CSV team members. Benefits of virtual training include ad-hoc sessions and real-time FAQ sessions that can be conducted at the end. Additionally, virtual classroom training can also be easily turned into on-demand, daily or weekly walk-in sessions during critical project weeks.
- Provide role-based Standard Operating Procedure (SOP) & Technical Operating Procedure (TOP) with added assessment to ensure procedures are clearly understood and tested.
Using a combination of these methods at the beginning and/or throughout project phases facilitates awareness of CSV requirements. Training can be tailored according to different teams/roles functions and different project phases as well as delta training in case of process updates or deviations.
3. Embed CSV in the Project Delivery Process – Do it Right First Time
Integrating the CSV team in your global transformation projects early is a key success factor for high-quality project deliverables (check out Key Success Factors in Global SAP Business Transformations on this). Practically binding CSV members into your core team allow for close collaboration, defines clear CSV requirements (frameworks, templates and training, etc.) and ensures that CSV guidelines are being followed, guaranteeing Quality Assurance. Based on our experience, not proactively involving the CSV team throughout the whole project or only including them at the end of a phase may lead to misalignment on what needs to be done and how something should be done, resulting in rework. In order to effectively collaborate with the CSV team and integrate CSV governance within your processes, we recommend the following:
Appoint CSV SPOCs (Single Point of Contact)
In large-scale global transformation projects, consisting of cross-functional teams or workstreams, we recommend appointing CSV SPOCs to support the team with CSV related queries. In addition to knowing whom to contact, bottlenecks and impediments can be resolved faster and more efficiently.
Having CSV SPOCs allows teams to identify CSV requirements (e.g. deliverables, approval and signature rules, team training) early in the project and thus allows the team to work towards their completion in a more focused manner.
Grant early access to Documentation (Deliverable) Checklists
The CSV relevant documents follow strict criteria how something must be documented. Normally, these criteria are either captured on SOPs or Checklists that can be distributed to the teams responsible for creating project relevant documentation, such as Functional Specifications, Configuration Guides and Design Specifications. By giving the team early access to these SOPs, the document deliverables can be approved, right first time, saving time for authors and reviewers, avoiding additional review cycles.
Introduce/Encourage CSV Walk-In Sessions
In addition to appointing CSV SPOCs and distributing checklists to the teams, it is beneficial to have weekly walk-in sessions. The frequency of the sessions can increase or decrease depending on the project phase. These sessions can be set up either for CSV SPOCs only to address specific topics or for a broader audience to address topics of general interest. Walk-in sessions can be a great way to create awareness of CSV relevant topics and to set expectations by the CSV team.
Consider CSV while doing Sprint Planning
When planning Design Sprints, it would be beneficial to structure them in a way that enables a continuous stream of document deliverables from the teams. Sprints may include a series of preparation, execution, review and firm-up (CSV review) weeks. In order to facilitate continuous submission of deliverables and encourage teams to submit them proactively for review, it would make sense to have these firm-up activities occurring on a weekly basis as opposed to once at the end of a Sprint.
By ensuring a continuous flow of documents, especially on large-scale transformation programs with multiple workstreams, bottlenecks for CSV review at the end of a Sprint can be avoided.
CSV plays an important role in large-scale global transformation programs in regulated industries. Understanding the requirements given by Quality/CSV can help reduce rework of deliverables, saving additional effort while at the same time decreasing the risk of project delays due to documentation.
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