The primary goal of archiving is to provide integrity, traceability, and availability of all key data.
Electronic archiving solutions help companies ensure archiving and long 
term access to digital data. Electronic long-term archiving is a concept ensuring that data is stored for more than ten year. This is fairly important to understand the difference between long-term archiving concepts and short-term concepts such as backups. Revision-proof electronic archiving is used to store electronic, business-related data. This archiving concept complies with the requirements of the German Commercial Code (section 239 and 257), the German fiscal code (section, 146, 147 and 200) and the Principles of Regular Data Processing-supported Accounting Systems (GoBS). Revision-proof electronic archiving ensures that electronic accounting documents are kept securely for a period of six to ten years.
When designing an archiving strategy companies have to consider several aspects of archiving to satisfy specific requirements related to data retention, disposal and change history. This also includes considerations on the implementation of an electronic SOP management system.
The following points provide further guidance on archiving to you:
- The archiving is a challenging organisational task for any organisations.
- There has to be a clear (physical) separation between the running application and the archiving solution.
- The implementation of an archiving solution ensures compliance with legal and regulatory requirements.
- The outsourcing of any archiving outside of your duties and daily activities provides significant benefits.
- There is a positive, effective and productive work environment.
- Risk and risk management for the archiving fall within the remit of the archiving service provider.
- Financial claims are excluded by the contractual relationship between you and the archiving service provider.
- The archiving of data should be planned carefully.
The Chemicals Act (ChemG) contains guidelines on archiving. In division six, section 19 the safety measures designed to protect against hazardous substances provide details on Good Laboratory Practice (GLP). Appendix 1 of section 19a, subsection 1 describes the principles for GLP. Appendix 1, chapter II provides information on archiving and storage of records and materials. Additional information is provided by the principles of Regular Data Processing-supported Accounting systems (GoBS), the principles of Data Access and Auditing of Digital Documents (GDPdU), and GAMP 5 (released in 2008).
Back to Guidance and Regulations on SOP management systems
