The expenditure is accordingly high: allocation to the quality assurance and complete documentation of the work procedures during the production of therapeutics and diagnostics can take up to three quarters of the work time.
In addition to the DIN EN 45001 the GLP (Good Laboratory Practice) regulates the requirements of the documentation as a special QA system for regulated areas.
A GLP compliant assay contains a long chain of procedures which must be documented and archived, which puts its ‘professional’, ie competent execution, nearly into the background:
- An inspection scheme before each assay.
- Justification and permission in the case of later necessary deviations from the inspection scheme.
- Examination (audit) by QA personnel during critical phases of the assay.
- Information of the head of laboratory and of the director of assay in the case of not approved deviations from the inspection scheme or from SOPs.
- Explanation of director of assay for GLP compliance (GLP declaration).
- Explanation of the QA unit over accomplished audits and reports of any deviations (QA declaration).
- The complete archiving of all documents, including raw data, test reports and QA recordings connected with the assay.
The following example from a laboratory of a larger company illustrates the archiving expenditure: for a simple identity assay 145 documents have to be archived and kept for 30 years. From the moment of archival on the director of assay may see these again only in the presence of the archives responsible person.
Today nearly all data and documents in GxP adjusted environments are produced electronically. Expression, handling and archiving all these data on paper cost daily time and money. Instead of printing out everything to file, to arrange and to archive, the direct electronic subsequent treatment and archiving contain great saving potentials. Particularly with the organisation, regaining and allocation of the data (eg order No, analyser, SOP, co-worker, etc) an electronic data and document management system has immense advantages in relation to a paper file.
A condition for this is – beside the 21CFRpart11 and eGLP conformity respectively – that the data, document management and archive system must be easily integrated into the existing structures and preferably processes and archive all electronic data uniformly leaving a small footprint in the existing applications. u
COI Consulting für Office und Information Management GmbH, Herzogenaurach. Germany. www.coi.de
