Validation Project Planning

Performance Validation professionals plan CSV projects, using a Risk Based Approach, to find the most efficient, cost-effective, high-quality, method for your system to meet your business needs while achieving regulatory compliance.

This is achieved by the system's risks, software category (based on system design complexity), supplier assessments and/or audits, and other objective factors drive documented justification for focused testing and streamlined documentation requirements - controlling your project costs and minimizing timelines while not sacrificing quality and regulatory requirements.

Typical Validation Project Planning Activities / Deliverables include

Project Management

(including, Expense, Project Status and Milestone management and tracking reports)

• Validation Master Plans and Procedures
• Validation Plan development & implementation
• Regulatory Gap Analysis and Remediation (e.g. 21 CFR Part 11, cGMP, GLP)
• Supplier/Vendor Audits
• System Risk Assessments
• Standard Operating Procedure Authoring/Consultation
• Leveraging Vendor Documentation (to reduce validation burden)

System Design and Specification

Eliciting, writing, and managing system specifications are among our many areas of expertise.

Performance Validation professionals understand the need for accurate, complete, and testable requirements which are scaleable based on configured or custom software development. Specifications are a fundamental component to any software solution. They are the foundation of system design, intended business use, and testing .

Typical System Design and Specification Activities / Deliverables Include

User Requirement Specification

• Functional Requirement Specification
• Design Specification
• Traceability of Requirements through Testing

Software Testing

Testing plays a central role in a validation project. Whether you and your stakeholders require assurance that your system is installed correctly, functions properly, and/or performs based on your intended use, Performance Validation has the right-sized approach.
In addition, Performance Validation recognizes that excellence in testing is essential to controlling project costs and maintaining timelines.
Leveraging supplier/vendor testing is a viable option for many systems and processes, as well as applying your system risk level to an appropriate Risk Based Approach. Performance Validation has the skilled resources in house to develop and execute test protocols.

Typical Software Testing Activities / Deliverables Include

• Infrastructure hardware and software qualification. Application qualification validation
• Installation Qualification – IQ of the application installation and configuration testing of the configured elements
• Operational Qualification – Functional testing of the application (depending on the GAMP5 category this testing may be fulfilled through vendor audit, or full functional testing where warranted) do demonstrate the software functions per the design requirements
• Performance Qualification – Use case testing, testing used to verify that the software meets the user requirements and the intended use of the software
• Performance Validation can write and execute IQ/Configuration/OQ and PQ tests and test scripts as required
  

Reporting

Summary Reports provide internal/external auditors and stakeholders with valuable information on the validation process and status of the system.

Typical Validation Project Reporting Activities / Deliverables Include

• IQ/Configuration/OQ/PQ summary reports
• Software vendor audit reports
• Validation plan summary reports
• Project reporting – to provide the client with up to date status of cost, schedule, and quality metrics of the validation project
  

Change Management

Performance Validation can assist the client in the management and validation of new projects; we can also provide a similar service for changes, modifications, and upgrades to IT Infrastructure and/or application changes.

Typical Change Management Activities/ Deliverables Include

In addition to the normal Validation activities of Planning, Specification, Testing and Reporting – PV can assist in developing and execution of the change control including archival of the obsolete software and data archive or migration to the new application.

Consulting

Performance Validation professionals have years of experience providing guidance and training on computer system validation. We can offer customized instruction on best practices and industry standards and can help you develop and implement a compliant computer system validation program.

Auditing

Performance Validation has a number of ASQ Certified Quality Auditors available to assist you. Our auditors have audited a number of software vendors in support of CSV projects.

In addition, our auditors can assist you in performing assessment audits of legacy systems. If you have systems which are not validated or which their validated-state may require remediation, Performance Validation can provide an audit to support in determining the best way to bring your "legacy" systems into compliance. We can then get your systems where you want them to be by implementing the plan.

Typical Auditing Activities/ Deliverables Include

• Audit notification
• Audit Schedule
• Audit Plan
• Execution and Conduct of the Audit (On-site or Postal)
• Audit Closeout/ Formal Report/ and Supplier Corrective Action
• Reports (SCAR)
• Additionally Performance Validation can perform internal audits/ assessments of legacy systems to provide a cost effective strategy to bring these systems into compliance
  

Business Information Systems

• Quality Management Systems (e.g. MasterControl QAAD™, TrackWise®)
• Document Management Systems (e.g. QUMAS eDocs)
• Business Process Management (e.g. PTC Windchill®) Packaging Labeling Systems (LabelVision®)
  

Process Automation Systems

• Programmable Logic Controllers
• Vision Systems, automated inspection
  DCS / SCADA
• BMS / UMS (e.g. Johnson Controls Metasys ®)
• HMI (e.g. Rockwell Automation RSView ®)
  

Applications/ IT Infrastructure

• Data Archive Management Systems
• Table / Report Generation Systems
• Application Database Systems
• Virtual Server Applications
• Web-Based Applications
• Spreadsheets
• Server Qualifications
  

Laboratory Information Systems

• Laboratory Information Management Systems (LIMS) (e.g. Watson LIMS™)
• Enterprise Data Collection Systems (Provantis®)
• Data Analysis (e.g. PK data modeling/analysis – Pharsight WinNonlin®)
  

Laboratory Instrument CSV

• HPLC/Mass Spectrometry analysis and control (e.g. Analyst®)
• Flow Cytometry (BD)
• Cell/Molecular Biology and Immunology (Applied Biosystems PCR analysis - 7900HT Fast Real-Time PCR System and SDS Enterprise Database, Roche Cedex Analyzer, ADInstruments PowerLab, Agilent 2100 Bioanalyzer, Meso Scale Discovery Sector® Imager 2400)
• Clinical Pathology (e.g. blood gas, chemistry, hematology, urinalysis analyzers)
• Spectrophotometry (e.g. NanoDrop™ 8000)
• Image Capture and Analysis Systems (microPET scanner, GE Vivid 7™ Ultrasound, Hamilton Thorne TOX IVOS)
  

Custom Applications

• Task Scheduling
• Master Schedule control
• Laboratory tools
• LIMS