Superior Vendor Compliance Archiving

by | Oct 8, 2021 | Adamas News, Blog Of The Day, Industry Focus, Regulatory Focus

At ADAMAS we have made a commitment to all our clients to ensure safe, accurate and secure retention of critical information relating to the services we have provided.

For example, the final version of audit reports as well as the CV and Training Record of the individual that conducted the audit are available to the audit sponsor on request in perpetuity.

Can you be certain all providers can make this claim?

The importance placed on records retrieval and archiving within our industry is paramount and highlights the importance of maintaining complete and accurate documentation (ICH GCP Section 2.10 states that ‘all clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification’ and FDA 21CFR820.180 Records Retention). Usually lending itself to a clinical site setting, we see endless numbers of audit findings which cite the failure to maintain adequate and accurate records.

At ADAMAS we are proud of our consistent compliance with this expectation and believe passionately that our standards of record keeping should be as rigorous as those to which our clients are held to account in the handling of CT data.

We believe it to be of immense value that our clients can recall a record of the work we have undertaken, and relevant details of the resources utilised.

Established over 23 years ago, ADAMAS take pride in the fact that any client can be certain that a copy of the high-quality audit report and ratification of the calibre of the auditor can be requested at any time.

The day when an inspectorate requests a copy of an audit report, or any other information for that matter, you need to have it to hand. Indeed, recently a client requested a missing audit report from 2015 that formed part of their dossier. ADAMAS were able to provide a copy of the document the same day.

For further information or for details of how ADAMAS’s experts can help, please contact us or call us on +44 (0)1344 751 210 in Europe / +1-919-341-3361 in the US.