Pharma Competency

Modular Validation & Documentation for Regulated Packaging Systems

Comprehensive validation support designed to reduce risk, ensure compliance, and support pharmaceutical, biotech, and medical device manufacturing environments.

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End-to-End Validation Support Built Around Your Process

Tekpak provides complete validation and documentation support for packaging automation systems, helping manufacturers meet regulatory requirements while maintaining efficiency and control. From early-stage URS analysis through to FAT, SAT, and post-installation validation, our approach is structured, compliant, and aligned with GAMP 5 methodology.

  • Full validation lifecycle support (URS → FAT → SAT → Go-Live)
  • GAMP 5 aligned validation methodology
  • Documentation and protocol development
  • Risk-based validation and compliance strategy
  • Support across pharma, biotech, and medical devices

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Fully customisable solutions by Tekpak

Trusted for Regulated Validation Support

The machine has been running fantastically. We have been running pretty much 24/7 for the last 2-3 months, passing 60-70k components through the machine daily, so have probably loaded in the region of 5M components already this year!
A Major UK Based Manufacturer of Meter Dose Inhaler (MDI) ProductsHead of Projects & Process Development
We have been using your equipment now on our Packaging Line for a number of weeks, and it is consistently performing with little or no issue.   For a transfer of pouches that I would have had quite a bit of concern about, it is great to see the consistent reliability and functionality of your equipment.
Top 5 Global Pharmaceutical CompanyEngineering Manager
I have been extremely impressed with your installation and commissioning team over the past 2 weeks.   The commitment shown and the work ethics is a credit to your business.   The team in the area have been involved through out and everyone has been very positive about the new equipment.
Multi-National Food GroupOperations Manager
What impressed us most about Tekpak was the attention to detail on the initial concept and proposal. It was clear that they had considered the risks and come up with technical solutions to address these.
Top 10 Global Pharmaceutical CompanySenior Project Manager
Tekpak team! Just passing by to say it was a great (and busy) year. I want to say thanks! It was an excellent learning working with you guys on the projects and I look forward for the next steps and new projects for next year!
Top 20 Global Pharmaceutical CompanyProject Manager
The pick and place system is virtually maintenance free. We got pay-back in under a year, increased throughput and saved on labour & material costs
Top 50 Global Pharmaceutical CompanySite Manager
Tekpak are forward thinking and developed Lean processes, easy to work with and very professional, met deadlines with good attention to detail and organised meetings and review of URS to insure delivery on time.
Multi-National FMCG ManufacturerFactory Manager
We have completed several projects with Tekpak and have always found them to deliver professional, well managed projects with excellent after sales support.
Multi-National Food ManufacturerEngineering Manager
There were only a handful of companies who were able to develop a technical solution for our application. We were very pleased that we chose Tekpak.
Top 10 Global Pharmaceutical CompanySenior Director R&D
Tekpak were able to come up with an innovative solution that no other supplier could match. We have found them approachable and professional.
Top 10 Global Pharmaceutical CompanyProject Manager

Comprehensive Documentation Packages

Our validation documentation is structured to support both equipment-level and full-line projects.

Tekpak Validation Documentation Packages_page-0001

Our projects are managed using the Agile Project Management SCRUM Method. From Project Kick-Off to Design Qualification,  Fabrication, FAT, Installation and SAT Handover our projects operate in 2-4 week sprints.  Clear objectives and milestones allow our agile project teams to respond quickly and efficiently which reduces lead times allowing our machines to go into full production more quickly.

Validation Support

Validation Support Aligned with Your Requirements

We take a structured approach to validation by first understanding your User Requirement Specification (URS) and overall project objectives. Where required, we support in refining technical specifications to ensure alignment with regulatory and operational expectations.

All projects are executed using GAMP 5 methodology, following a defined quality and project plan. The full validation lifecycle is documented – from design specifications and qualification through to testing, approval, FAT, and SAT – ensuring complete traceability and compliance.

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Structured Validation Lifecycle

Our validation process ensures compliance at every stage of the project while maintaining efficiency and transparency.

Project Kick-Off & URS Alignment

Define user requirements, scope, and validation strategy aligned with regulatory expectations.

Design Qualification (DQ)

Validate system design against URS with risk assessments and technical documentation.

System Build & Integration

Manufacture, assemble, and integrate systems with full traceability and control.

Factory Acceptance Testing (FAT)

Test system performance, functionality, and compliance before site delivery.

Site Acceptance Testing (SAT)

Verify system performance in the production environment under real operating conditions.

Validation Support (IQ / OQ / PQ)

Support installation, operational, and performance qualification to meet compliance standards.

Go-Live & Ongoing Support

Ensure smooth system launch with continued technical and validation support.

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REGULATORY & COMPLIANCE SUPPORT

Supporting Complex Regulatory Requirements

We support clients in addressing key regulatory and compliance challenges across validation and system implementation:

  • Risk-based validation strategy and execution

  • Quality Management System (QMS) alignment

  • Development of validation plans and documentation

  • Computer System Validation (CSV)

  • GAMP 5 V-model implementation or custom frameworks

  • SOP development and training programmes

  • Data integrity consulting and audit readiness

  • Validation of cloud systems (IaaS, PaaS, SaaS)

Our experts are ready to support you on-site!

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Agile Delivery for Faster, Controlled Implementation

Our projects are managed using Agile (SCRUM) methodology, enabling structured delivery with flexibility.

From project kick-off through design, build, FAT, installation, and SAT, work is delivered in sprint cycles with defined milestones – ensuring transparency, control, and faster execution without compromising compliance.

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Need Validation Support for Your Packaging Project?

Our team can help define the right validation strategy, documentation approach, and compliance framework for your system.

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Validation & Documentation Contact Form

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