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Typical GMP documentation in a quality control laboratory

GMPSOP

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

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How to implement good documentation practice in a GMP regulated plant

GMPSOP

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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Why intelligent automation is the future for regulation

pharmaphorum

To improve data confidence regulatory executives should take a four-step approach to change how they: Collect Data: Life sciences organisations should utilise cloud-based solutions with global access that facilitates one repository with a single source of truth and eliminates the use of local file sharing and servers.

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VIATRIS (Mylan & Up-John Pfizer) -Openings for Regulatory Affairs Department -Apply Now

Pharma Pathway

(Merger between Mylan Laboratories & Up-John Pfizer) URGENT Opening @ VIATRIS for Regulatory Affairs- Injectables | Exp: 2-7 Years | Bangalore | Send Resumes to HR Department: Regulatory Affairs -Injectables Qualification : Masters in Pharmacy is mandatory Experience : 2 – 7 years Designation : Executive/ Assistant Manager Key responsibilities: (..)

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How blockchain can revolutionise medical records and save lives

pharmaphorum

Many practitioners have expressed the feeling that EHRs cause far too much of their time ultimately being spent on data entry. Additionally, issues such as poor quality documentation due to template-based reporting, and incompatibilities between different systems have further caused headaches and increased inefficiencies.

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Life in phase III: How effective data management can support NHS Trusts to hit their targets

pharmaphorum

This document, which went out at the end of July, outlines exactly what providers need to be doing. Refining data cleansing strategies – Using those data dashboards, Trusts should augment data cleansing and validation strategies to ensure any issues identified in data entry are quickly tackled.

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Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.