Faster end-to-end quality review process ensuring data integrity using ALCOA+ principles
By 
admin
02-Feb-22

Checking and reviewing the suite of validation documentation can be very time consuming.  TQS Integration can provide the resources needed to ensure GMP and all regulatory compliance requirements are met. Why not let us do the heavy lifting - providing you with faster end-to-end quality review processes - to ensure speed to value and implementation of your processes and more importantly freeing up your capacity and resources. TQS Integration can help to alleviate these pressures by placing people with the right skills, at the right time, in the right place.

  • Full End to End Project lifecycle
  • Independent Quality Oversight
  • Project Documentation Delivery
  • Experience of an eligible Qualified Person with over 30 years of Pharmaceutical experience.
  • Using TQS Expertise and skillsets in delivering RFT documentation set
  • Delivering the highest standard of Compliance and Support to you, our customer. 
  • Proven track record in delivering Validation projects, on time and on budget
  • Combined Industrial experience of over 50 years
  • ALCOA+ principles followed at all stages of review on data integrity
Data Integrity
  • Team of dedicated PI System Quality professionals supporting your end-to-end Quality review process.
  • Reducing costs of overheads
  • Compliance with FDA and Annex 11 Regulations
  • Consultants and Technical experts who have extensive knowledge within the pharmaceutical industry and the application of 21 CFR Part 11.
  • GMP as an essential component of Quality Assurance
  • GAMP 5 – Validation Methodology

TQS PI Documentation set will provide evidence that the PI System has been validated.

The expected system lifecycle steps include but not limited to:

  • Project Quality Plan
  • User Requirements Definition,
  • Detailed Design Specification
  • Installation and Operational Qualification
  • Maintenance Plans for the PI System

"I want to thank you all for all the great work and all your efforts to expedite this important validation activity and everything you are doing in general. I really appreciate it. Not only can we put our validation work in your trusted hands, but your work has also freed up so much time for us to focus on other areas of the operation."-Top 10 Pharma Company

How we can help you

At TQS, the validation strategy has been developed to systemically test the PI System at different levels.  The Installation Qualification (IQ) covers the minimum set of verification to assure proper installation of the software components for the PI System.  Operational Qualification (OQ) will verify the correct operation of the PI system against the user requirements and design specification including those around data acquisition and storage, start up and shutdown and high availability etc.

Dedicated Quality Assurance Engineers will monitor, review, and approve every phase of the process to ensure the implementation and design of the PI System adhere to company standards and regulations.  QA will conduct and participate in every phase of the SDLC including requirements review, design review and test case reviews including test evidence.  Having empirical evidence of the fact that the PI System works as expected ensures a successful outcome during inspections with regulatory organisations.

For information, please contact us.

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