Top Tips For Installing Patches In A Regulated Environment
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A software patch is a must product for major software manufacturers all over the world. From Microsoft to Apple and from Adobe to Corel, these giant companies issue this software periodically. What make these patches very essential that they have become a part of the flow of the computer system? Improvement of performance, fixing of problems, and security reasons-these are the main functions of the application. Patches in Biotechnology companies must be tested fully before go-live.
Security is the most critical area of computing nowadays and being secure is the most important business requirement out there. Patches are released to enhance security / “patch” vulnerability or to deliver a bug fix or enhancement; this is basically a situation such that patches are either reactive or proactive. Ensure that each application undergoes a risk assessment before they are implemented.
Reactive patches are plugging holes that have been exploited by hackers or “cyber terrorists” – some new trojan has found yet another back door that will cripple your business. React now and install the new patch! Microsoft have released it so it’s absolutely necessary. Is this really the case? No it is not.They have probably not tested it with your DeltaV or LIMS system – how will the patch affect your business? What if it mandates a new .NET framework that your propriertry application software can’t understand?Reaction is risk in the world of patching the minimum risk is losing performance – the greater risk is losing production and/or reputation. Validation is an important part of installing new patches onto a system, you need to figure out if an application needs to be revalidated after the installation of a new patch.
Try to minimize risk (change) at all costs. Spend ample time investigating the root of the issue by having a series of test or development system to implement patch installation prior to the real execution of the system. Have a documented test run for a few days. The advantages and the disadvantages of applying the patch to the business should be taken into consideration. The benefits and the amount of risk should be weighed. This requires a thorough risk analysis and options should be presented to minimize it.
Regardless of the urgency of the situation, a change management process should be used that includes a roll-back plan as well as a reasonable level of testing (in accordance with the risk category). Does the patch have to be applied to the production system first? Or is there a smaller area that can be used, e.g. a development system or just a subset of the overall set of computers that will require the patch? In any case, release the patch slowly whilst testing continuously to make sure the change control details not only how to do the installation, but also how to revert back and make sure that the systems can be reinstated to the post-patch condition.
As the final step, make sure that you have a copy of the approval of the change in writing. The change should be clearly documented with details on what it intend to do, how it was implemented and used, as well as when the change was made and by whom. This is a precautionary measure and disclaimer on your part in case of future incidents that might be blamed on what you did. This would also serve as a reference and a record to make the necessary changes or rollbacks in the change control pack.
Want to find out more about Software Patches in a Regulated Environment, then visit Premier Infrastructure on how to choose the best approach for installation of the software patches in a regulated environment.
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