The following pages provide some detailed information on signature, data backup and archiving. Additionally, you will find regulations that life science organisations have to adhere to for SOP management.
There are various aspects to consider in terms of electronic signatures. Electronic signatures reduce the expenses and time allocations that paper-based approval processes require and produce legally binding electronic records. Read more
Data backup should be a priority for companies and their IT departments. The need for a data backup technology in life science companies is significant. According to the regulations of the Food and Drug Administration (FDA) appropriate security measures must be taken to prevent accidental loss of data. For more details and information about backup system requirements click here.
Archiving solutions leverage backup of data and help businesses comply with the 21 CFR Part 11 guidelines set out by the US Food and Drug Administration (FDA) for long-term retention. The combination of backup and archive applications in a single system provides both short-term and long-term protection of data from accidental modification, destruction or disclosure. Read more
Various regulatory bodies set out compliance requirements for SOP management systems such as the US Food and Drug Administration (FDA), World Health Organization (WHO), European Union and German legislature. Find out more about regulation and compliance. Read more
There are three ways for document management:
- paper-based document management
- hybrid systems
- integrated electronic systems
Paper-based document management has been standard practice in companies for many years. Documents are created, managed and stored on paper. With the introduction of personal computers businesses changed from traditional paper based document filing systems to hybrid systems. Hybrid systems, on the one hand, provide electronic document management but paper-based storage and archiving of documents. With fully integrated electronic systems, on the other hand, printouts can be partly or completely avoided. Integrated electronic systems provide management, storage, and archiving of electronic records.
