Computer System Validation (CSV)
“Defining what the system should do and documenting it can actually do it”
What are the common elements in a CSV program?
A computer system validation program should define your company’s approach to ensuring your systems operate as intended and produce reliable data used to support GxP operations. A typical program will include:
- Roles and Responsibilities
- Risk Assessment Approach for Computerized Systems
- Process and Procedural Controls
- SDLC Methodology (GAMP5, etc.)
- Periodic Review Approach
- Testing Approach
- Data Integrity
- Change Control & Change Assessments
- Part 11 / Annex 11
- Record Retention/Archival
- System Decommissioning
What we do?
Mangan Biopharm offers personnel who can provide computer system validation (CSV) support for your systems supporting GxP activities in the heavily-regulated biopharmaceutical Industry. Whether your scope is a single system, complete CSV program development, or an audit of your existing program against current industry standards, Mangan can provide resources to fit your specific needs.
Why choose Mangan?
After twenty years of providing services to our clients, our personnel have the expertise to work with you on projects of all sizes. Regardless of project scope and size, Mangan Biopharm can provide expert professional services to deliver projects on time and on budget without sacrificing quality.
Regardless of what methodology you follow, a good CSV program will begin with defining how the system will be used (user requirements) and evaluating the risk of implementing the system (risk assessment) in your environment. From there, proper planning and a robust testing process will confirm the system is capable of meeting the user requirements and applicable regulatory requirements (ERES, Data Integrity).
Electronic Records/Electronic Signatures (ERES)
21 CFR Part 11 and the EMA Annex 11 regulations detail the expectations for computer systems used for GxP purposes.
Electronic Records/Electronic Signatures (ERES) compliance begins with an understanding of what constitutes the original record and how that data is used to support GxP activities. Once a full understanding of the use of the electronic record is understood, the capability of the system to apply an attributable electronic signature can be assessed and challenged. Some of the fundamental components of ERES compliance include:
- ERES Data Policy
- Acknowledgement of the use of ERES by the company and its staff
- A Data Map demonstrating the GxP data produced by the system and how it will be used
- Data Protection and Security
- Data Quality (ALCOA)
- Data Revision History (Audit Trail)
Data Integrity Principles
Good Documentation / Data Practices
Good documentation and data practices extend from paper records into electronic records and management of both. Data Integrity has at its foundation quality data and an understanding of how the data is used to support GxP activites. A common definition of quality data includes data that meets the principles of ALCOA or its extension ALCOA Plus.
Information is captured in the record so that it is uniquely identified as executed by the originator of the data (e.g. a person or a computer system).
Legible, Traceable, and Permanent:
Data are readable, understandable, and allow a clear picture of the sequencing of steps or events in the record so that all GXP activities conducted can be fully reconstructed by the people reviewing these records at any point during the records retention period set by the applicable GXP.
Data recorded at the time they are generated or observed.
the first or source capture of data or information and all subsequent data required to fully reconstruct the conduct of the GXP activity.
Data are correct, truthful, complete, valid and reliable
The plus component of ALCOA adds the following intrinsic principles:
All data are available, nothing has been deleted (evidence: audit trail).
Data are recorded chronologically with data and time (evidence: audit trail).
Data are accessible for an extended period of time – after 20 years.
Data are accessible over the lifetime of the product.
- Quality Systems: Trackwise, Documentum, MasterControl, Pilgrim
- LIMS: LabWare, LabVantage
- EMMS: Maximo, Blue Mountain
- Drawing Management: Adept, BlueCielo, Autodesk Vault
- CDS: Empower, OpenLab
- Data Historian: OSI Pi, IP21,
- DCS: Allen-Bradley/Rockwell Platforms, DeltaV
- BMS/BAS: Siemens, Rockwell
- PLC/SCADA: ABB, Rockwell, Siemens, Wonderware
Commission and Qualify the new Change Management group of workflows in TrackWise/Quest. The new Change Management project included 5 workflows (3 new and 2 modifications of existing workflows). The Change Management workflows will be utilized at three sites and qualified for use at each division and additionally as a global division for managing changes shared across sites.
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Client: Major Global Pharmaceutical Corporation Project Duration: 3 months Overview: Mangan was contracted as a final attempt to integrate an automated particle monitoring system for a large pharmaceutical manufacturing facility, located in the Eastern USA Three...
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Eastern and Midwest Regions