Dear business partner,
We are pleased to inform you about a current improvement to our laboratory information and management system (LIMS): various extensions to the system allow us to forward electronically released tests to you directly in future as test reports with an electronic signature.
By dispensing with manual signatures we can accelerate our internal release processes, in other words, you benefit from the faster submission of reports as a result of the electronic signature. As of the second quarter, we will also be sending you the test reports as PDFs per e-mail directly from our LIMS system. Your benefits:
Our Quality Assurance has conducted considerable research on the use of electronic signatures in a pharmaceutical environment. Various information is available on electronic signatures in the EU-GMP Guideline, Annex 11 as well as in 21 CFR, Part 11 and also in various regulations (Aide Memoire 07121202, EFG vote V11003, PIC/S PI 011-3 etc.). In our research we also took the German Law on Signatures (SigG) into consideration. However, as the AMG (Medicinal Products Act) and the AMWHV (German Ordinance on the Production of Pharmaceuticals and Active Substances) do not make reference to the signature law, implementation of the requirements provided there are not mandatory.
Therefore Labor L+S AG has defined in-house rules on electronic releases and signatures based on the above mentioned regulations and with reference to the signature law. In future, we will be using an advanced electronic signature, i.e. which requires checking user recognition and entry of a personal password within closed systems for every test release. The test certificate won’t be printed out in future, but forwarded to you directly by electronic means.
We have already notified the supervisory authorities (government of Upper Franconia and FDA) last year about the use of electronic signatures at Labor L+S AG.
We have validated all changes in the LIMS as well as the transfer of test reports into an electronic archive in accordance with the regulatory and internal specifications and checked their perfect functioning intensively.
Documents which are not generated from the LIMS (e.g. validation reports, documents on special tests, etc.) are not affected by this reorganisation. Here, you will continue to receive manually signed test and validation reports.
If you have questions or require explanations to further details, please contact Ms Könemann.
Divisional Manager of Quality Assurance
Im Zuge des Versands von Weihnachtsgrüßen an unsere Geschäftspartner hatten wir...
Mangelsfeld 4, 5, 6
97708 Bad Bocklet-
Fon: +49 (0)9708/9100-0
Fax: +49 (0)9708/9100-36
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