![]() Our own QMS is based around the GAMP®5 principles and we are both experienced and pragmatic in our delivery, you get what adds value and not documentation for the sake of documentation.Īs the biotech / biopharma industry has grown, so too has our knowledge and involvement in that from a regulatory point of view, but also, from a ‘value adding’ solutions delivery too. We started in the GxP era, pre GAMP® and have been involved in the developments of GAMP® from v1 to v5, including additions like 21CFR11 compliance and Serialisation, Data Integrity and have had an active involvement in several ISPE SIG groups over the years too. Since 1991 we’ve grown as a business providing systems and support to the pharms industry. ITS Ltd experience in the pharmaceutical sector started nearly 30 years ago.
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