Disaster recovery plans

Does the computer room have limited access (e.g., are the servers physically/ logically secure) 2. Are there provisions for power backup 3. Is there a disaster recovery plan and is it periodically tested 4. Is there environmental monitoring 5. Are there off-site back-up facilities for key documents and software Is it readily retrievable ... 

Establish system backups and disaster recovery plans. 

Establish a disaster recovery plan that allows for rapid recovery from any emergency (including a cyber attack). System backups are an essential part of any plan and allow rapid reconstruction of the network. Routinely exercise disaster recovery plans to ensure that they work and that personnel are familiar with them. Make appropriate changes to disaster recovery plans based on lessons learned from exercises. 

Second, disaster situations represent real and potential threats to data integrity. Evidence of appropriate preventive action and recovery strategies must be presented, generally in the form of a disaster recovery plan with an annual practice drill. The disaster recovery plan is usually organized aroimd likely problems (flood from broken pipes, fire, electrical failure, etc.) and includes appropriate notifications, substitute activities, and recovery actions. The disaster recovery plan generally interacts with system backup, recovery, and archive SOPs. 

Business Continuity Planning (Disaster Recovery) A disaster recovery plan should be in place to ensure the continued operation of the laboratory in case of an adverse event that renders the instrument out of commission and hence causes interruption to the business processes which the system supports. Adverse events like the failure of the critical hardware components of the instrument and the failure of the application software do happen in the day-to-day operation of a laboratory. The disaster recovery plan should provide the necessary steps to restore the systems back to a functional state. The steps typically include instructions to reinstall the application software to the personal computer controlling the instrument, to reconfigure the instrument, and to restore the backup data to the instrument. 

Procedures and plans supporting business continuity (Disaster Recovery Plans and Contingency Plans) must be specified, tested, and approved before the system is approved for use. Business Continuity Plans will normally be prepared for a business or an operational area rather than for individual computer systems. It is likely that the only way to verify the plan is to walk through a variety of disaster scenarios. Topics for consideration should include catastrophic hardware and software failures, fire/flood/lightning strikes, and security breaches. Alternative means of operation must be available in case of failure if critical data is required at short notice (e.g., in case of drug product recalls). Reference to verification of the Business Continuity Plans is appropriate during OQ/PQ. 

Business Continuity Plans are sometimes referred to as Disaster Recovery Plans or Contingency Plans. There are two basic scenarios ... 

Walk through contingency and disaster recovery plans to check they are still applicable. 

Toigo, J.W. (2000), Disaster Recovery Planning, Prentice Hall, Upper Saddle River, NJ. 

Contingency plans and emergency operation This is a disaster recovery plan and includes the use of alternative plans until the computer system has been recovered. It is important that any disaster recovery plan is tested and verified that it works before any disaster... 

Good computing practices require that a documented and tested disaster recovery plan must be available for all major computerized systems. It rarely is. Failure to have a disaster recovery plan places the data and information stored by major systems at risk, the ultimate losers being the workers in the laboratory and the organization. 

To prevent the loss of critical GxP data, backups of systems should be taken at regular intervals, as documented in local SOPs. This prevents the physical loss of important system data or its accidental deletion by users. A backup also provides a basis from which the application can be restored in the event of an unforeseen event arising that results in the need to invoke the documented Disaster Recovery Plan. Data that should be subject to backup activities includes system software, such as the operating system and any preconfigured software modules, application software, and... 

Servers should be located in secure locations subject to appropriate environmental controls and protected against risks of flooding, fire, etc. Business Continuity Plans and Disaster Recovery Plans should be in place to manage catastrophic events. Such plans should be periodically tested. 

Configuration management Disaster recovery plans/procedures Vims protection Backup and Restoration Security Management... 

Disaster recovery plan Business continuity plan... 

Disasters include the full range of unplanned catastrophes, from internal or external sabotage to the extreme forces of nature, like fires, tornadoes, and earthquakes that do real damage to a corporation s physical assets. Each of these occurrences presents a serious risk to an enterprise s profitability and viability. It is, therefore, essential that disaster recovery plans be well-conceived and fully supported by management. 

The data files and the completed CRFs generated from the clinical trials are more precious than the hardware. In addition to daily and monthly back-up, pharmaceutical companies should have a detailed recovery plan in case of unexpected disaster. The disaster recovery plan should include the following ... 

Off-site storage. In order to be operational at the off-site process center for critical applications, the files that need to be updated to the off-site center are master files for all completed projects, daily back-ups for ongoing studies, monthly system files, monthly glossary updates, monthly safety monitoring, NDA files and production job streams. The protocols, CRFs, regulatory documents, rules and manuals should also be stored off-site. A drill of the disaster recovery plan should be put to test at least every 6 months to reveal any unanticipated problem. 

Business Continuity Plans cover both Contingency Plans and Disaster Recovery Plans. 

Disaster recovery plans exist and have been tested... 

Availability of user SOPs - Availability of Disaster Recovery Plans... 

The most common "disasters" are a power failure and a hard-disk failure however, other disasters also need to be considered, if appropriate. A Disaster Recovery Plan should be available for each system as well for the central computer facilities. Such a plan (or SOP) should describe all activities required to restore a system to the conditions that prevailed before the disaster. If applicable, actions to be taken in case of a disaster should be described at the departmental level. Disaster recovery procedures should be tested initially and, if applicable, also periodically. 

System management (e.g., formal contract or SLA, system management documentation, documented responsibilities, overviews of system components, existence of and adherence to change control procedures, backup and restore procedures, physical and logical security, Disaster Recovery Plans)... 

Definition of the measures to be taken to allow an operation or process to continue as associated computer systems become unavailable. Sometimes known as a Business Continuity Plan or Disaster Recovery Plan. 

We describe some models of the disastrous events spreading. This is a very important part of risk analysis. Despite the strong dependency of successive events, after some arrangements we can use Markov models for the description. It allows us to compute several characteristics of such system. When we consider a system of objects among them a disastrous event could spread, we can compute a probabdity distribution of absorbing states, first passage times for any of the objects and many others. This modeling can help us to make some preventive decision or to prepare disaster recovery plans. In the paper, the model is described and some computations are outlined. Keywords risk, safety, successive event, disastrous event, markov chain. 

It is also important to note the disaster recovery planning is embedded in more general governance structures, playing out within ideological. 

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