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Solutions and training for Data Integrity, Data Governance, QMS, Laboratory Systems, Manufacturing Systems, and Medical Devices.

Solutions and training for Data Integrity, Data Governance, QMS, Laboratory Systems, Manufacturing Systems, and Medical Devices.

Data Integral Ltd are expert in providing Data Integrity, Data Governance, CSV, and project management solutions for companies engaged in the manufacture and testing of licenced medicinal products and Medical Devices.
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Blog

9 March 2022 danielmilek01

It has been a pleasure working with the dedicated and hard working folks at Guy’s and St.Thomas Pharmacy Manufacturing Unit,…

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Posted in: Computer Systems Validation, Data Integrity, GAMP, PIC/S, Training

An updated version of the ISPE Good Engineering Practice GPG

8 December 2021 danielmilek01

Good Practice Guide: Good Engineering Practice 2nd Edition | ISPE | International Society for Pharmaceutical Engineeringhttps://ispe.org/publications/guidance-documents/good-practice-guide-good-engineering-practice-2nd-edition

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Posted in: Engineering, ISPE, Training Filed under: engineering, GPG, ISPE, pharma

OECD 22 (GLP Data Integrity Guidance) latest Sep release.

24 November 2021 danielmilek01

Click on image to read and download.

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Posted in: Data Integrity, OECD, Training

A new Qualitalk on the process of CSV, featuring our Managing Director and Yan Kugel from Qualistery.

13 November 2020 danielmilek01

Alternatively you can watch it on the Qualistery YouTube channel here: https://www.youtube.com/watch?v=9UcQhh-6om8 Also check out Qualistery here: https://qualistery.com

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Posted in: Computer Systems Validation, Training

A new Data Integrity discussion for you featuring our Managing Director.

7 September 2020 danielmilek01

Yan Kugel is recording some great Pharma related talks via his company Qualistery. Our Managing Director, Daniel Milek, recorded a…

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Posted in: Data Integrity, Training Filed under: Data Integrity

Our updated 2020 Training Modules are available for purchase. Get in touch for a quote!

15 March 2020 danielmilek01

We offer interactive Training Modules at very competitive prices. Subjects include CSV, Data Integrity, and Data Governance. See our Services…

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Posted in: Training

Revision of EudraLex Volume 4 annex 1 is available in draft and open for comment and contribution until 20 May 2020.

1 March 2020 danielmilek01

https://ec.europa.eu/health/medicinal_products/consultations/2020_sterile_medicinal_products_en?fbclid=IwAR1FW81w2ftY4QDZwNi-g1w5QJ06tumIA-QuY1YA9ZIapZbvUYn1jnilYWY

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Posted in: EudraLex

AI is starting to impact drug discovery with use of pharmacokinetics models.

27 February 2020 danielmilek01

AI was always going to be of use in pharmacokinetics. Here it comes. https://sifted.eu/articles/ai-transforming-pharma/?fbclid=IwAR3TSboG7VYnv7LNLl7ijarcSVubxoqG-1xp46ADibTck3e5tsTqn3SYSTU

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Posted in: Artificial Intelligence

T-cell discovery sounds promising for cancer treatment!

21 January 2020 danielmilek01

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Posted in: Immunotherapy, Oncology

A crisis in Antibiotics.

13 January 2020 danielmilek01

A crisis in antibiotics with companies going under. Hopefully the UK trial of a medicines subscription service will help the…

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Posted in: Antibiotics

EC EudraLex Volume 4 Part IV – ATMPs.

7 January 2020 danielmilek01

We wonder how many businesses and individuals working with ATMPs (Advanced Therapy Medicinal Products) are aware of the EC EudraLex…

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Posted in: EC, EudraLex Filed under: ATMP, EC, EudraLex, GMP

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