Business continuity, management planning

At the OQ stage there will be a need for the pharmaceutical manufacturer to ensure that the appropriate management systems in terms of procedures and Business Continuity (Contingency) Plans have been assessed and confirmed as suitable. In some cases it may be that as part of the OQ process draft versions of the procedures and Business Continuity (Contingency) Plans are developed with the revised documentation being issued following the completion of OQ. 

Tang showed that supply chain risk can be treated through mitigation, using strategic and tactical plans (Table 5.4). This type of impact on risk is associated with the business continuity management (BCM) concept - see Section 5.2, which includes the contingency plans developed at operational level. 

Business Continuity Management—Processes are provided to develop, communicate and implement plans for responding to incidents and unplanned events. It should include identifying qualified personnel and adequate resources required to manage potential adversities. 

DESIGNED and MANAGED a fee-based financial planning system incorporating investment, fringe benefits, business continuation, and estate planning. 

Business Continuity Plans define how significant unplanned disruption to business operations (sometimes referred to as disasters) can be managed to enable the system recovery and business to resume. Disruptions may occur as a result of loss of data or outage of all or part of the computer system s functionality. The range of circumstances causing disruption can range from accidental deletion of a single data file to the loss of an entire data center from, for instance, fire. 

All LIMS functions (e.g., manual data entry, automated data entry, and report generation) should be assessed to evaluate the effect that they could have on the data that will support regulatory submissions and release of product to market. This approach must be methodical to ensure that relevant functionality is not overlooked. It is essential, for instance, that Business Continuity Plans are verified as being appropriate and workable. This testing should cover all aspects of the recovery process from the loss of individual components (e.g., an analytical instrument interface) to the full loss of LIMS (e.g., representing a catastrophic failure of the LIMS server). The criticality of the data associated with the management of Electronic Records and Electronic Signatures should also be a focal point. However, it must be accepted that these assessments can be subjective and therefore they rely heavily on the experience of the assessors. 

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. 

Some pharmaceutical mamrfacturers are implementing extranet web-enabled applications established with suppliers and business partners. Extranet includes Virtual Private Networking (VPN) and offer cheaper Web solutions. Remote node access is achieved using a client with a browser connected to a corporate Web address or Universal Resource Locator (URL). The challenge is ensuring security across the Internet link. A secure session or tunnel is established between the VPN server and the end user workstation. Internet Service Providers (ISPs) and telecommunications carriers are endeavoring to provide a managed extranet/VPN service to corporate subscribers. A major benefit of Web-enabled applications is the ability to recover from disaster scenarios. Business Continuity Plans can actively make use of such applications. 

Infrastructure architect Configuration/asset management Business continuity planning Network capacity... 

Clear and proper procedures must be in place for using the system (procedures and/or user manual), backup and restoration, periodic evaluation, maintenance and problem management, safety and security, training. Disaster Recovery and Contingency Plans, business continuity, change control, and system retirement. 

The NFPA 1600 standard was first published on April 1, 2004, and revised in 2007. NFPA issued the 2010 Edition in December 2009. The newly published standard reordered the content of the 2007 version. Chapter 4 was expanded to emphasize the importance of commitment and leadership. Chapter 5 was broken into four chapters dealing with planning, implementation, exercises, and improvement processes. In November 2009, the new NFPA 1600 received certification by the passage of The SAFETY Act. We can best describe the purpose of the standard as to help the disaster management, emergency management, and business continuity communities to cope with disasters and emergencies. 

Zsidisin G.A., Melnyk S.A., Ragatz G.L., 2005, An Institutional Theory Perspective of Business Continuity Planning for Purchasing and Supply Management, International Journal of Production Research, 43(16), pp. 3401-3420. 

Management principles of authority, responsibility, and accountabihty Business continuity and contingency planning... 

With the advent of the Civil Contingencies Act 2005 there is a legal duty on local authorities to provide advice and assistance to organisations requiring help on business continuity planning and management. In order to comply, local authorities will have to demonstrate that they have taken reasonable steps to promote business continuity advice within their boundaries. 

Though business continuity plans are not necessarily safety focused, many times, they have huge safety implications and for that reason should be described here (though they may be published separately). Emergency management plans are more tactical than business continuity plans and usually focus on immediate safety implications to employees or the public. Actual emergency response procedures are also usually published separately and are collected in Part II Operational Safety Requirements. 

Detailed emergency response procedures, call plans and call trees, and other emergency response actions are included here. Though business continuity is related to emergency management, those business continuity actions and activities that have safety implications are also included here. 

Maintaining Security Level during Operations (includes Maintenance, Change Management and Incident Handling), Disaster Recovery and Business Continuity Planning). This is a critical issue in context of safety certification Security outlives rather quick its life time, so frequent updates are necessary - quite opposite to what safety people want, to avoid re-assessment and re-certification ... 

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