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Pharmaceutical Data Integrity
Ensure Data Integrity. Ensure Compliance.
Protect your pharmaceutical data from integrity risks and stay fully compliant with FDA, MHRA and EMA requirements.
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Audit-ready records. Complete, reliable, correct, and consistent data.
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Data Assessments to quickly identify potential integrity gaps.
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Proven experts. 20+ years supporting global Pharma and Biotech.
« Inadequate data integrity can become a danger for companies. We identify risks and point out ways in which to minimize them. »
Stefan Münch, Business Director Validation & QM
How it works
Step 1: Briefing & Risk Analysis
You describe your challenges; we identify critical data integrity risks across your systems and processes.
Step 2: Tailored Concept
We create a customized data integrity strategy aligned with ALCOA+ principles and global regulatory guidelines.
Step 3: Execution and Reporting
We implement with full documentation and prepare you for audits and inspections.
Why We’re Different
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ALCOA+ at the core. Ensure data is Accurate, Legible, Contemporaneous, Original, and Attributable.
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Global compliance. FDA, EMA, MHRA, WHO – we navigate complex regulations for you.
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Digital expertise. Support for modern digital systems like LIMS, MES, on premises and cloud platforms.
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Risk-based focus. Prioritize what matters most to patient safety and business continuity.
Who We Work With
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Pharmaceutical, Biotech, and MedTech companies
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Systems: MES, LIMS, ERP, Manufacturing Equipment, Laboratory Systems
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Early-stage startups to top-tier global companies
Frequently Asked Questions
Why do I need to fill out the information requested?
We will always keep your personal information safe.
We ask for your information in exchange for a valuable resource in order to
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Is this really free?
Absolutely!
Just sharing some free knowledge that we hope you’ll find useful. Keep us in mind next time you have pharma manufacturing questions!
Who is this for?
This content offer is for anybody in pharma and biotech who is looking to reduce the carbon footprint of their supply chain and packaging operations.