Computer System Validation

PAATAM Technology services has provided "Computer System Validation" services to a number of world class pharmaceutical companies and can deliver that same world class service to your company. Computer System Validation services may be provided a-la-cart or as a turn-key solution including project management as required by the client. Services include the following validation deliverables:

  • Quality Assurance/Validation Plans
  • User Requirement Specifications
  • Functional Requirement Specifications
  • Detailed Design Specifications
  • Vendor Audit Reports
  • Master Test Plans
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • User Acceptance Test (UAT) documents
  • Process Qualifications
  • Testing Execution
  • Test Summary Reports
  • Training Plans
  • Quality Assurance/Validation Summary Reports
  • SOPs, Guidelines

Capabilities:

  • The PAATAM Technology services staff has performed validation services on the following systems in regulated companies in accordance with FDA regulations and SDLC procedures:
  • Control systems for sterile/biotech equipment/systems including Lyophilizers, Sterile/Bioreactors, filter systems, Filter Integrity Test Systems, Pressure/Temperature Controls, Packaging Systems and Environmental controls.
  • Laboratory systems including Ovens, Coolers, Freezers environmental controls, Chromatography Data Collection Systems, Lab Instrumentation, Laboratory Information Management Systems (LIMS), including Sample Manager LIMS, Watson LIMS, Beckman LIMS, Win LIMS, SQL *LIMS, Labvantage LIMS.
  • Other instruments validated include: UV-Vis spectrometers, FT-IR, FT-NIR spectrometers, NMR, High Performance Chromatography (HPLCs), Gas Chromatographs (GCs), and capillary HPLCs.
  • Information Management Systems including Electronic Documentation Management Systems (EDMS) including Documentum 4i, iXOS, Excel Spreadsheets, Maintenance Management Systems (MMS), Manufacturing Resources Planning system (MRP II), Enterprise Resource Planning system (ERP), Order Management Systems (OMS), Supervisory Control and Data Acquisition Systems (SCADA) and Manufacturing Execution Systems (MES).

 

Key deliverables of a Paatam validation engagement include:
  • Validation Plan
  • User Requirements Specification
  • Functional Requirements Specification
  • System Design Specification
  • Vendor Audit
  • Master Test Plan
  • Unit, Integration Test Plans
  • Installation Qualification Protocols
  • Operational Qualification Protocols
  • Performance Qualification Protocols
  • User Acceptance Test Protocols
  • Training Plan
  • Traceability Matrix
  • SOP Audit
  • Test Summary Reports
  • Validation Summary Report

Paatam provides staffing for your computer system compliance projects. We will provide your organization with best industry experts to help expedite your computer validation projects.

Regulatory Publishing

Project management services from Paatam build upon our proven expertise and approach to project management to deliver IT solutions that meet the demanding requirements of our Clients & Partners. Our project management skills span multiple industries and technologies.

Paatam has Well-supported and experienced project managers with skills in different enterprises to provide the project management services to the Clients & Partners. Our project managers are trained in FDA and SOX regulations to support the projects in regulated area. Paatam will engage project managers in our software application development implementation efforts and provide them for your internal project implementations as consultant to implement the expertise. Our documented approach allows our customers to understand the project deadlines, budget, purpose, and scope of the implementation.

Key deliverables of a Paatam project management engagement include:

  • Project Plan
  • Deliverables Road Map
  • Risk Assessment
  • Roles and Responsibilities Matrix
  • Change Management Plan
  • Implementation Plan
  • Training Plan
Consulting Services

Paatam offers a host of services to our clients to meet their Staffing requirements, Payrolls, Back office administration, Training. We are a dedicated team of professional consultants offering top line executive search and selection across the globe. Paatam offers a full range of Recruitment, Contract staffing, Manpower & HR Services for Executive Search.

Listed below are the industries and specialty area where we provide resources:
  • BFSI (Banking Financial Services & Insurance)
  • BPO & KPO
  • Construction/Infrastructure/Real Estate
  • Government Sector
  • Healthcare & Pharmaceutical
  • IT
  • Manufacturing
  • Power & Energy
  • Telecom
  • Automobile
  • Bio-Technology

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