Ongoing Support and Integrity Checks System Management

ONGOING SUPPORT AND INTEGRITY CHECKS (SYSTEM MANAGEMENT) 

Maintaining the validated status of the ERP system requires management of the network, servers, ERP functions and data. To ensure the validated status of the ERP system is retained during operation, change control must be in place, along with periodic reviews of system status. Implementing a series of procedures and maintaining physical access control to ERP servers supports the maintenance of validation over the life of the system. 

Change control of the ERP hardware, software and associated documentation (SOPs and operating manuals) is necessary and requires that changes be recorded, specified and assessed for GxP impact. Changes are to be approved by qualified personnel and tested, with records of testing retained. 

Effective network security is important to ensure ERP data are not corrupted or accessed by unauthorized personnel. Threats can come from viruses or external sources such as vandals via the Internet. More than 10,000 viruses exist, with an estimated 6 new viruses appearing each day. Network virus protection combats this threat but requires constant updates to detect new strains (e.g., the recent Laroux virus). Installing a firewall is one of the best ways to protect networks from attacks via the Internet. Whatever the protection strategy employed, close monitoring and auditing is important to ensure the protection is effective. 

The ease with which hardware and software may be implemented also implies that change is straightforward. Implicit with computer systems is the rate of change of the available hardware and software. Current computer hardware and software has a life cycle of approximately two years, and upgrading of 

---

Ongoing support and integrity checks (system management)... 

---