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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.

 

生命科學公司面臨越來越大的壓力，需要使用先進的制造工藝和科學，以確保制造的藥物符合患者安全、產(chǎn)品質(zhì)量和數(shù)據(jù)完整性的合規(guī)性要求。此外，社會和政治壓力要求他們生產(chǎn)出在經(jīng)濟階梯中更廣泛的患者負擔得起的藥物。為了實現(xiàn)這些以患者為中心的結果，他們不僅在操作和系統(tǒng)中設計質(zhì)量，還需要進行驗證，以確保這些系統(tǒng)和工藝按照設計運行。本文討論驗證項目失效并導致注冊成本增加的原因。

 

What is Validation

 

什么是驗證

 

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).

 

驗證是測試的書面證據(jù)，以證明計算機化系統(tǒng)和工藝始終如一地按照設計運行并"適合使用"。由于已驗證的系統(tǒng)必須保持驗證狀態(tài)，因此需要對已驗證系統(tǒng)的任何變更進行再驗證。因此，驗證是一種經(jīng)常性成本，如果不以最佳方式執(zhí)行，可能會明顯增加成本（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:

 

許多驗證項目總是超支預算，并且不能按照預定時間完成。這個難題通常會導致管理層對驗證成本產(chǎn)生懷疑。在管理層的成本控制壓力下，存在削減開支的趨勢，從而導致合規(guī)性風險增加。本文提供了導致驗證項目失效的因素，以及如何主動解決這些因素以避免“無效”驗證。監(jiān)管檢查員對驗證的常見發(fā)現(xiàn)項和缺陷項包括：

 

Failure to validate a system used for regulatory     purpose

 

未能驗證受監(jiān)管系統(tǒng)

 

Absence of written procedures for validation

 

缺乏書面的驗證程序

 

Absent or inadequate objective evidence of     validation

 

客觀驗證證據(jù)不足或不充分

 

Validation SOPs are not followed

 

未遵循驗證SOP

 

Validation is not risk based

 

驗證未能基于風險

 

Factors contributing tovalidation failure

 

導致驗證失敗的因素

 

Validationproject failure can be attributed to the following factors:

 

驗證項目失效可歸因于以下因素：

 

Unclear project objectives and methodologies

 

項目目標和方法不明確

 

Failure to engage all stakeholders consistently

 

未能一貫地讓所有利益相關方參與其中

 

Absence of proactive project risk management

 

缺乏主動的項目風險管理

 

Untrained or poorly trained validation team members

 

驗證團隊成員未經(jīng)培訓或培訓不足

 

Lack of project status in real time

 

未能實時更新項目狀態(tài)

 

Gaps in communication

 

缺乏溝通

 

Unclear project objectives and methodologies

 

項目目標和方法不明確

 

 

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.

 

項目負責人必須明確定義驗證項目的目標。項目經(jīng)理應在項目開始時制定清晰、簡潔的項目執(zhí)行計劃（PEP），并對PEP 培訓每個項目團隊成員。由適當?shù)睦嫦嚓P方在項目開始時制定的清晰、明確、有效、簡潔的系統(tǒng)需求和用戶需求也是項目成功的關鍵?？煽康尿炞C項目計劃（VPP）是驗證主管的責任，它應概述驗證活動的范圍、測試方法、測試團隊及其職責以及接受標準。未能規(guī)劃上述事項是驗證項目失效的基礎。

 

Failure toengage all stakeholders consistently

 

未能一貫地讓所有利益相關方參與其中

 

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.

 

成功的項目來自一支利益相關方團隊的持續(xù)參與。業(yè)務部門領導、質(zhì)量人員、IT、QC 實驗室和工程部門等。它確保持續(xù)調(diào)整和合作，以應對因范圍變化、人為錯誤等不斷變化的情況而產(chǎn)生的挑戰(zhàn)。一套明確的既定目的和目標，并在整個項目期間進行審查，是推薦的最佳做法。

 

Absence ofproactive project risk management

 

缺乏前瞻性的項目風險管理

 

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.

 

這是項目管理中最受忽視的方面。在項目啟動和團隊組建過程中，團隊無法前瞻性地識別、分析和降低范圍、計劃和預算的項目風險。預先這樣做可以防止項目風險的被動處理，從而為管理層提供了項目團隊對項目失控的視線。制定和發(fā)布項目風險管理計劃并對整個項目團隊進行風險培訓是明智的。

 

Untrained orpoorly trained validation team members

 

驗證團隊成員未經(jīng)培訓或培訓不足

 

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.

 

驗證是一個以業(yè)務為中心的活動，其中在由一系列活動組成的業(yè)務流程中，用于得出結果，例如：經(jīng)過驗證的系統(tǒng)。但是，如果我們將注意力集中在相關要素（如人員、團隊和領導力）上，就能成功實現(xiàn)成果。對人員進行驗證原則和方法的，以及驗證要求的相關法規(guī)的培訓至關重要。向他們解釋，為什么他們需要執(zhí)行所要求的事情，以及如果未能這樣做對合規(guī)性的影響，也非常重要。還必須培訓驗證 SOP ，包括變更管理等，以避免因錯誤而從頭來過。

 

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.

 

還應作出規(guī)定，為項目過程中新成員加入建立上崗培訓計劃。多數(shù)人為因素風險可通過無紙化驗證或所謂的自動化驗證過程消除。

 

Lack of projectstatus in real time

 

缺乏實時項目狀態(tài)

 

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.

 

執(zhí)行管理層經(jīng)常抱怨說，他們沒有實時了解所有項目的當前狀態(tài)。不幸的是，當對成本、計劃和范圍造成重大或不可逆轉(zhuǎn)的影響時，他們才意識到關鍵問題。因此，必須以簡潔明了的方式（如看板）實時顯示這些變化。

 

Gaps incommunication

 

缺乏溝通

 

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.

 

項目狀態(tài)實時可見還可通過項目團隊成員定期例會、及時發(fā)布會議紀要、在下次會議上令人滿意地處理和報告已發(fā)現(xiàn)的問題、確保所有利益相關方定期出席這些會議、發(fā)布 RACI（誰負責（R = Responsible）,誰批準（A = Accountable）、咨詢誰（C = Consulted）,通知誰 (I =Informed)））圖表、實時確定關鍵路徑以及分配資源以將這些活動從關鍵路徑中移出等。

 

In conclusion

 

結論

 

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.

 

業(yè)務策略要求系統(tǒng)和工藝的驗證是執(zhí)行管理的優(yōu)先事項，驗證目標必須通過適當?shù)挠媱潯L險管理、通過規(guī)劃和需求定義防止范圍蠕變、與項目利益相關者商定接受標準以及確保包括項目申辦人在內(nèi)的執(zhí)行管理層實時持續(xù)了解項目狀態(tài)，從而有效地實現(xiàn)驗證目標。