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Increasing focus on Data Integrity in Life Science

28 april, 2016


Data integrity is one of the life science industry’s hot topics. It’s not new, having been included in 21 Code of Federal Regulation (CFR), Part 11 in 1997. However, it is something that is affecting every pharmaceutical company today.

With several high-profile breaches in recent years, data-generating systems and business processes are coming under intense scrutiny. Within the area of cGMP, regulatory authorities are increasingly focusing on the integrity of electronic and paper-based data.

Ensuring compliance
Pharma companies need to ensure controls are in place and continually managed in order to reduce the risk of non-compliance and to be fully-prepared for inspections from regulatory agencies, such as the FDA, MHRA and the Medical Products Agency in Sweden.

Achieving data integrity requires that systems are validated and provide high quality, accurate data, which is legible, secure, permanent and available throughout the entire data lifecycle. These requirements apply to both electronic and printed data.

PlantVision’s extensive experience within the life science industry, together with its core expertise in the areas of quality management and computerised systems, make it the ideal partner for companies looking to ensure they comply with data integrity regulations as efficiently as possible.

 

Find out more about data integrity
Attend one of our breakfast seminars: “Data integrity – ensure correct quality and meet regulatory demands”

UPPSALA, 10/5, Info & registration (Swedish only) »

SÖDERTÄLJE, 13/5, Info & registration (Swedish only) »


 

Download our Data Integrity information sheet »


Or contact:


Sanna Hjelm
Business Area Manager, Manufacturing Information

Tel. +46 8 503 045 81
E-mail: sanna.hjelm@plantvision.se

Anna-Lena Mann
Business Area Manager, Quality Management

Tel. +46 8 503 045 50
E-mail: anna-lena.mann@plantvision.se


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