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Validation

  • Validation

Principia is a provider of robust technical solutions with high quality and compliance standards. As part of our holistic offerings, we include commissioning and qualification services and computer system validation (CSV) services. These are also provided as stand-alone services based on customer needs.

Validation

Commissioning
and Qualification

At Principia it’s our goal to help our clients ensure their process, manufacturing and packaging equipment, facility, utilities perform as the intended design. Our experienced commissioning and qualification team provide technical skills, knowledge and experience to make our clients’ projects successful.

Throughout the commissioning and qualification services and using a technical risk-based systematic methodology, Principia can reduce the extent of commissioning and qualification (C&Q) activities and ensure that the system or equipment will function reliably within specific limits.
Our services include:

  • Planning, development, document generation, revision, execution and close out reports for all technical decommissioning, Commissioning & Qualification (C&Q) activities tailored to meet your corporate policies, procedures and validation methods

  • Development and Execution of Testing Protocols (FAT, SAT, COMM, Decommissioning, IQ, OQ, PQ) and User Requirement/Design/Functional Specifications

  • Project Management, Auditing, and Training

  • Generation of Standard Operating Procedure such as Manufacturing and Packaging Area, System & Security Administration, Backup & Restore, Business Continuity, Periodic Reviews, Retirement Operational and Cleaning SOPs
Validation

Computer System Validation

At Principia, our Technical Services Area offer a broad range of services in support of manufacturing, laboratory, packaging and enterprise systems. Principia can support the computer system validation and system testing efforts across multiple projects and multiple sites to help our clients ensure the integrity, reliability and availability of their regulated process data to support the production activities.

Our services include:

Project Initiation and Planning
  • Project Management
  • Software Development Life Cycle (SDLC) Process Definition
  • Gap Assessments
  • Risk Assessments
  • Validation Planning
  • ERES Assessments
System Requirements and Design
  • User Requirements Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Design Review
  • Supplier/Vendor Audits
System Development and Verification
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requirements Traceability Matrix
High-Quality Services

Our Services

Industries

Our highly skilled staff is disciplined to work within a range of industries in the dynamic life sciences sector, to meet demanding and evolving expectations.

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Process Automation

Our process and industrial automation personnel are trained to offer a broad scope of services to meet or exceed your project goals.


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Manufacturing IT

Manufacturing Execution Systems (MES) expertise to orchestrate manufacturing operations, connecting real-time data originated at the shop floor with enterprise level applications.

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Technical Services

We ensure that your process, manufacturing, packaging equipment, facility and utilities perform as the intended design.

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Validation (C&Q and CSV)

As part of our wide expertise, we provide commissioning & qualification and computer system validation solutions.

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Project Management

We help your operations complete their project on time, under budget and meeting 100% of the requirements.

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