Audit

To comply with prescription drug anti-counterfeiting mandates do you have the following questions ? 

• What will it take for your packaging line(s) to comply with multiple anti-counterfeiting mandates from different countries?
• What are the primary / alternate options available and which option will allow to comply with future mandates?
• What are the time, cost, risk, ROI and downtime estimates?
• What are the impacts to throughput/efficiency of the packaging line?
• Can additional benefits (Operational Excellence) be achieved?

We can help you answer questions like these by auditing your packaging lines. Please contact us and we will email you the audit details.

Installation

Our engineers have over 30 years of experience implementing projects for pharmaceutical domain following the stringent System Deployment Life Cycle – SDLC.

We will work with the client to choose the right technology to achieve compliance, improve productivity, quality and mitigate risks.

Our project implementation process involves the following milestones and gates

• Gather requirements
• Select solutions (vendors / products)
• Design (review and approve)
• Develop Test (review and approve)
• Install
• Validate Train
• Support

In addition we will adhere to the customer specific project life cycle methodology. Please contact us for more details.

Validation

Our engineers have over 30 years of experience implementing projects for pharmaceutical customer following full life cycle FDA validation.

We have successfully completed multiple mission critical validation projects which have passed FDA site inspections.We have developed validation protocols (URS, FS, DS, IQ, OQ, PQ and summary reports) for

• Software (SCADA, HMI and MES)
• Packaging machinery – unscrambler, filler, capper, cottoner, labeler, vision system, topserter, checkweighers, case packer
• Packaging line monitoring and control (PLC)
• Other

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