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嘉峪检测网        2021-10-11 23:11

Why Validation Projects Fail



Life Sciencescompanies are under increasing pressure to use advanced manufacturing processesand sciences to ensure that manufactured drugs meet compliance requirements ofpatient safety, product quality and data integrity. Additionally, social andpolitical pressures require them to produce drugs that are affordable to abroader section of patients across the economic ladder. To achieve thesepatient-focused outcomes, they are not only designing quality into theiroperations and systems, but they are also validating them to ensure that thesesystems and processes function as designed. This article addresses whyvalidation projects fail and result in signification cost increases.



What is Validation



Validation isthe documented evidence of testing to verify that computerized systems andprocesses consistently perform as designed and is “fit for use”. Sincevalidated systems must be maintained in a validated state, any changes tovalidated systems are required to be re-validated. Thus validation is arecurring cost and if not performed in an optimal manner, could significantlyincrease the Cost of Goods (COG).



Many validationprojects invariably overrun budgets and fail to meet schedules. This conundrumoften results in management eyeing validation costs suspiciously. Under costcontainment pressures from management, there is a tendency to cut corners whichresults in an increased compliance risks. This article provides factors thatcause validation projects to fail and how to proactively address those factorsto pre-emp failures. Some of the common observations and citations onvalidation by regulatory auditors include:



Failure to validate a system used for regulatory     purpose



Absence of written procedures for validation



Absent or inadequate objective evidence of     validation



Validation SOPs are not followed



Validation is not risk based



Factors contributing tovalidation failure



Validationproject failure can be attributed to the following factors:



Unclear project objectives and methodologies



Failure to engage all stakeholders consistently



Absence of proactive project risk management



Untrained or poorly trained validation team members



Lack of project status in real time



Gaps in communication



Unclear project objectives and methodologies



It is important for the project sponsor to clearly define the validationproject objectives. The Project manager should develop a clear and conciseProject Execution Plan (PEP) at the start of the project and train everyproject team member on the PEP. A clear, unambiguous, validatable and concise SystemRequirements and User Requirements developed at project start by theappropriate stakeholders is also the key to a successful project. A robustValidation Project Plan (VPP) is the responsibility of the Validation lead andit should outline the scope of validation activities, the testing approach, thetesting team and their responsibilities and the acceptance criteria. Failure inplanning in areas stated above is the foundation for the failure of aValidation project.

项目负责人必须明确定义验证项目的目标。项目经理应在项目开始时制定清晰、简洁的项目执行计划(PEP),并对PEP 培训每个项目团队成员。由适当的利益相关方在项目开始时制定的清晰、明确、有效、简洁的系统需求和用户需求也是项目成功的关键。可靠的验证项目计划(VPP)是验证主管的责任,它应概述验证活动的范围、测试方法、测试团队及其职责以及接受标准。未能规划上述事项是验证项目失败的基础。


Failure toengage all stakeholders consistently



Successfulprojects result from the continued engagement of a set of stakeholdersconsisting of the project sponsor. business unit executives, quality personnel,members from the IT, QC laboratory and engineering groups etc. It ensurescontinuous adjustment and alignment to meet challenges arising from changingsituations such as scope changes, human errors etc. A clear set of definedgoals and objectives, reviewed throughout the term of the project is arecommended best practice.

成功的项目来自一支利益相关方团队的持续参与。业务部门领导、质量人员、IT、QC 实验室和工程部门等。它确保持续调整和合作,以应对因范围变化、人为错误等不断变化的情况而产生的挑战。一套明确的既定目的和目标,并在整个项目期间进行审查,是推荐的最佳做法。


Absence ofproactive project risk management



This is the mostneglected aspect of project management. During project setup and teamformation, the teams fail to proactively identify, analyze and mitigate projectrisk to scope, schedule and budget. Doing so up front will prevent projectrisks to be addressed reactively which provides management the optics of theproject team as having lost control of the project. It is prudent to developand publish a Project Risk Management Plan and educate the entire project teamon the risks.



Untrained orpoorly trained validation team members



Validation is abusiness centric activity where in a business process consisting of a sequenceof activities are used to derive an outcome e.g. a validated system. However,outcomes can be successfully achieved if we individually focus our attention tothe associated elements – such as people, team and leadership. Training peopleon the principles and methods of validation along with the associatedregulations that validation is required to satisfy is critical. Explaining tothem why they are required to do what they are required to do along with theimpact to compliance if they fail to do so is also very critical. Training themon the Validation SOPs to include Change Management etc. is also necessary, soas to avoid rework due to error.

验证是一个以业务为中心的活动,其中在由一系列活动组成的业务流程中,用于得出结果,例如:经过验证的系统。但是,如果我们将注意力集中在相关要素(如人员、团队和领导力)上,就能成功实现成果。对人员进行验证原则和方法的,以及验证要求的相关法规的培训至关重要。向他们解释,为什么他们需要执行所要求的事情,以及如果未能这样做对合规性的影响,也非常重要。还必须培训验证 SOP ,包括变更管理等,以避免因错误而从头来过。


Provision shouldalso made to establish a project onboarding training program for new projectmembers joining the team during the course of the project. Many of these risksdue to people factors may be eliminated through use of paperless validation oras the industry refers to as automation of the validation process.



Lack of projectstatus in real time



Executive management often complain that they do not have real time visibilityinto the current status of all projects. Unfortunately, they are made aware ofcritical issues when the impact on costs, timelines and scope are significantor irreversible. Since they are the final defense againstproject failure, it is critical that they be presented this visibility in realtime in a concise and clear manner such as in a dashboard format.



Gaps incommunication





Real timevisibility into a project status is also realized through regular standingmeetings of project team members, release of meeting minutes in a timely mannerso that issues identified are satisfactorily addressed and reported out duringthe next meeting, ensuring regular attendance of all stakeholder at thesemeetings, publishing a RACI (Responsibility, Accountability, Consult, Inform)chart, identifying critical path in real time and assigning resources to movethose activities out from the critical path etc.

项目状态实时可见还可通过项目团队成员定期例会、及时发布会议纪要、在下次会议上令人满意地处理和报告已发现的问题、确保所有利益相关方定期出席这些会议、发布 RACI(谁负责(R = Responsible),谁批准(A = Accountable)、咨询谁(C = Consulted),通知谁 (I =Informed)))图表、实时确定关键路径以及分配资源以将这些活动从关键路径中移出等。


In conclusion



Business expediencyrequires thatvalidation of systems and processes is a priority of executive management andthat the validation objectives are realized efficiently through appropriateplanning, risk management, preventing scope creep through planning andrequirements definition, an agreed to acceptance criteria with the projectstakeholders and ensuring that executive management including the projectsponsor has continuous visibility into project status in real time.