Checklist that will helpful in your next Inspection Part IV

Data Integrity app for Pharma Compliance

Checklist that will helpful in before Inspection

11 Prioritize Areas of Scrutiny

With the list of potential questions and possible documentation to provide, it is time to prioritize likely inspection points.

Identify between 5-10 likely areas that will be reviewed. For instance, if the review indicates the agency is concerned about management involvement and support for the company’s quality system, then what is it about management involvement and support that is likely to draw inspector scrutiny?

For a more virtual pharmaceutical firm, one specific area might be the effectiveness of supplier oversight in the context of management involvement.

Document Corrective Actions Properly: 

Ensure that, in the event there is a deviation, you are documenting all corrective actions correctly.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

12 Conduct Environmental Monitoring: 

If your company processes ready-to-eat food products that are exposed to the environment prior to packaging,

FDA will require you to have an environmental monitoring program. Ensure that an appropriate program is developed and implemented before FDA arrives.

13 Develop a Companion Sample Policy: 

When FDA collects food product or environmental samples, some companies elect to collect companion samples at the same time.

Although we typically counsel against this practice, if you choose to collect companion samples, make sure to have a policy in place governing exactly how those samples will be handled, tested and/or discarded following collection.

14 Develop a “Photographs” Policy: 

In many cases, FDA Investigators will insist on taking photographs while inspecting the processing environment.

If you have a corporate policy which helps visitors from taking photographs, you may be able to use the policy to FDA from taking pictures.

If the FDA inspector insists on taking photographs or other video or audio recordings, take and retain duplicates at the same time.

15 Develop a “Do Not Sign” Policy: 

At the conclusion of the inspection, the FDA investigators may ask you or your employees to author or sign a statement or affidavit describing the inspection, the observations and/ or the conclusions.

Sometimes, during an FDA inspection, the FDA Investigators will insist that a company representative sign a statement or affidavit.

You have no legal obligation to do so. Develop a policy that states you will neither sign nor acknowledge any written statements presented by FDA Investigators.

Do not sign, correct or acknowledge any documents, as you have no legal obligation to do so. If the inspector presents an affidavit for signature, politely decline to sign and tell the inspector that you must first consult with the FDA lawyer/ consultant

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Checklist that will helpful in your Next Inspection Part III

Data Integrity app for Pharma Compliance

Checklist that will helpful in before Inspection

6 Review the Notification Letter

With luck, the letter will spell out the type of inspection the Agency intends to conduct, including the records the inspector expects to review.

This may be a preapproval inspection (PAI), “statutory” inspection, a “for cause” inspection or a “follow-up” inspection.

In such cases, the inspection is largely confined to those areas identified in the letter; although, the inspector can, and sometimes does, ask about and review supporting documentation for other areas of relevance.

For example, one notification letter, sent by the FDA, informed a recipient that the Agency intended to conduct an inspection related to a whistleblower complaint around data integrity associated with clinical trial production or finished product contamination.

In that case, the inspection led to a review of risk evaluations for pilot plant production and process parameters, the risk evaluation, qualification and oversight of the active pharmaceutical ingredient manufacturer and so on, not just pilot plant batch records, electronic record integrity and clinical trial production quality control data.

7 Review Previous Inspections

Assuming the firm has been inspected by the Agency before, previous establishment inspection reports (EIRs) and FDA Form 483 observations should be available for review.

Companies that have not yet been inspected by the Agency can turn to their critical suppliers such as a contract manufacturer (CMO) or contract research organization (CRO).

This is especially important if the company is receiving a preapproval inspection or if a “for cause” inspection cites clinical or manufacturing oversight concerns.

The CMO or CRO may have been inspected by the Agency. If so, they will have EIRs and Form 483s that can be reviewed.

8 Review the QSIT Manual &FDA Guidance

The next step is to review the FDA’s Quality System Inspection Technique (QSIT) manual, Guidance documents on the FDA website & Relevant Harmonization Guidance’s.

Originally written to help inspectors of medical device and diagnostic firms since the publication of FDA’s Pharmaceutical cGMPs for the 21st Century:

A Risk-Based Approach with its emphasis on a holistic compliance framework and quality system, the QSIT is well worth the time to review; it provides example questions to which the FDA inspector might seek answers.

For instance, in order to assess the role of senior management in promoting and overseeing FDA compliance at a firm, the inspector may make sure to obtain answers to questions such as:

  • Have measurable quality policy
  • Objectives been implemented? Are quality audits conducted?
  • Does the quality unit have appropriate responsibility, authority, and resources?

9 Identify Records FDA are likely to Audit

Good organization of documents is important to successful completion of inspections. Organize all Regulatory Files by general heading arranged in chronological order (or reverse chronological order).

A visual presentation of documents can instill confidence in the inspector that the cGMP documentation practices are implemented and followed.

Well-written summaries too go a long way in simplifying the inspection. Inspectors may prefer well-written summaries over bulky documents.

10 Ensure Ease of Records Access:

Keep record handy & produce within specific time give confidence to auditors.

Ensure that the supporting records for each of the programs are organized and maintained in such a way that the Designated Individual can immediately retrieve the past three months of records for FDA review.

Although FDA requires the majority of these records to be maintained for at least two years, the FDA investigators will typically ask only to review records for the preceding three months.

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Checklist that will helpful in your Next Inspection Part II

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Before Inspection Checklist

Much of the work needed to ensure that the inspection ends successfully should be completed long before the FDA Investigators arrive.

All companies should begin work immediately to ensure that they have accomplished all the critical tasks.

1 Notify all staff /employee & contractual if pre plan/routine inspection:

Notify the Sponsor of the Inspection as soon as it is scheduled.

Notify all relevant site personnel of inspection responsibilities and schedule and ensure they are trained on interacting with FDA.

2 Drafting an Action Plan:

Most regulatory and quality professionals would agree that a best practice is to have a pre-defined inspection preparation action plan at the ready,

Rather than assembling & executing one in an ad hoc manner under a tight timeline in an environment suddenly fraught with the tension and anxiety inevitably accompanying the announcement of an impending inspection.

3 Review/Develop a SOP for hosting the inspections:

Review /develop procedure for hosting inspections and follow your procedure from beginning to end.

The ‘Hosting Inspections’ SOP must include:

  • Clearly state whom to contact first when the inspector shows up at the site. The facility’s quality lead and the site operations lead and their backups should first be notified.
  • Describe a mechanism for alerting the entire facility that an inspector is in the building
  • Describe how to document FDA requests for information
  • Describe how to handle the inspector’s request for photographs or videos
  • Describe the method to respond to FDA request that is not in agreement with your quality procedures such as entry to clean room during operations, hours of operations etc.

4 Develop an Inspection Readiness Team:

It is good to have a team that consists of members from the quality organization and cross-functional groups as part of the inspection readiness team.

This team can help in identifying and completing preparation activities and support the inspection throughout.

Assign right person for specific task is play vital role in inspection management. Various factor are consider for selection SME (subject matter expert).

The first step is evaluating your SMEs to decide which ones will fare best in an inspection and which others may present too much of a risk to put in front of investigators.

Assign a primary and secondary Designated Individual (DI) for each facility to serve as the liaison with the FDA Investigators once they arrive.

Designated Individuals should coordinate vacation time (and time off) to ensure that one DI will always be available in the event FDA arrives.

5 Identify a Meeting Space:

Identify a space within the facility to host the FDA investigators when they arrive.

This might be a conference room or a vacant office with sufficient desk space to review large amounts of records.

It is recommended that the FDA representative workspace be away from heavy traffic areas. The audit support room, also known as the war room should not be located close to the FDA representative’s meeting space. The war room sometimes becomes busy and inadvertently loud.

The escort should have made arrangements for a comfortable work area for the FDA inspector(s) for the duration of the inspection.  The room must contain no confidential records, including clinical or research related

The space selected, however, should be free of any records (in binders, boxes or on computers) which FDA Investigators could access, unsupervised, while they occupy the space.

  1. The room should have a phone, and allow convenient access to study staff.
  2. The room should be located away from the clinical/research area to avoid such activities from being conducted near the inspector.
  3. The room should NOT contain any other study or medical records, other than the study records that the inspector has requested.
  4. The room should be able to be locked when the inspector leaves.
  5. The requested staff should be readily available to the inspector at all times. (The inspector generally will not want the study staff coordinating the investigation in the room while s/he works.) 

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Checklist that will helpful in your Next Inspection

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In Earlier post we understood What FDA will expect from your Next Inspection.

Now in this article we are going to understand Checklist that will helpful in your Next Inspection

“By failing to prepare, you are preparing to fail” – Benjamin Franklin 

Proper preparation and planning prevents poor performance. To avoid any observation Check list play vital role in preparation of any inspection. Proper check list will minimize chances of mistake. Pepare proper check list for better inspection.

Refer below points while preparing Checklist

  • Review of existing Software Validation Lifecycle policies, SOPs, etc.
  • Identification of paper data, electronic data, raw data, and static and dynamic data
  • Intended use of computer systems (e.g., SOPs, workflows, etc.)
  • Use of notebooks and forms associated with computer systems
  • System security and access to data (e.g., user types, groups, roles, accounts, etc.)
  • Electronic signatures and audit trails
  • Data retention policies and availability of data
  • Data backup, archive, restore and recovery processes
  • Training for support and use computer systems that collect, generate, store, analyze, and/or report regulated data

We will share with you provenly effective tips and pointers for how to prepare for an audit and how to ensure your audit runs smoothly.

We divide Checklist into three parts:

  • Before Inspection Checklist
  • During Inspection Checklist
  • After Inspection Checklist  

I Before Inspection

  1. Notify all staff /employee & contractual if pre plan/routine inspection
  2. Drafting an Action Plan
  3. Review/Develop a SOP for hosting the inspections
  4. Develop an inspection readiness team
  5. Identify a Meeting Space:
  6. Review the Notification Letter
  7. Review Previous Inspections
  8. Review the QSIT Manual & FDA Guidance
  9. Identify Records FDA are likely to Audit
  10. Ensure Ease of Records Access
  11. Prioritize Areas of Scrutiny
  12. Conduct Environmental Monitoring
  13. Develop a Companion Sample Policy
  14. Develop a “Photographs” Policy
  15. Develop a “Do Not Sign” Policy
  16. Identify an Appropriate “On Call” FDA Lawyer
  17. Conduct a Mock FDA Inspection
  18. Building and Facilities. Check whether
  19. Equipment. Check whether:
  20. Personnel. Check whether:

II During Inspection

  1. Arrival of Inspector
  2. Opening Meeting
  3. Attempt to Negotiate the Areas Being Sampled
  4. Escort’s Role & Responsibility 
  5. Carefully Document the Areas Being Sampled by FDA:
  6. Hold any Product from any Lines that FDA Samples
  7. Aggressively Clean and Sanitize all Areas Sampled by FDA
  8. Correct all FDA Observations Immediately
  9. Know What Records FDA is permitted to Review
  10. Protect the Confidentiality of any Records FDA Copies
  11. Do Not Leave the FDA Investigators Unaccompanied
  12. Do Not Sign Any Statements or Affidavits
  13. Exit Interview

III After Inspection

  • If FDA Issues a FORM 483, Prepare a Written Response: 
  • Form 483’s written response should include
  • Support Your Written Response with Documentation:
  • If FDA Suggests a Recall, Consult Your FDA Counsel: 

Now we will see each point in checklist in details in next post.

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What is System Deliverable Matrix & Its usage in Computer System Validation?

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In Earlier post we understood what is Checklist which useful for Computer System Validation Documents Preparation & Review.

Now in this article we are going to understand What is System Deliverable Matrix & Its usage in Computer System Validation?

What is Deliverable?

A deliverable is any unique and verifiable generated results, or capability to perform a service that must be produced to complete a process, phase, or project in computer system validation.

The list of deliverables which shall be generated by the project team based on the GxP Assessment & system categorization checklist and system level risk assessment.

The most important thing is to define the desired project results and work through the deliverables to each of them. The more defined the deliverables are, the easier it is to forecast the timeline, the budget and the scope.

System Deliverable Matrix is subjected in nature for guidance purpose, number of deliverables may be changed based on system risk, complexity & Novelty and same shall be defined in Project Validation Plan.

System Deliverable Matrix

  1. Change Control Initiation Form
  2. URS Initiation Record
  3. Project Plan(schedule)
  4. Change Control Approval Form
  5. GxP Assessment & System Categorization Checklist
  6. System Level Risk Assessment
  7. Vendor Survey Form
  8. Vendor Audit Report
  9. URS Finalization Record
  10. Project Validation Plan
  11. Training Records
  12. Functional Specification
  13. Design Specification
  14. Requirement Traceability Matrix Initiation
  15. Functional Level Risk Assessment
  16. Configuration Specification
  17. Software Code Review Record
  18. Installation Qualification, Operational Qualification, Performance Qualification Protocol
  19. Test Scripts
  20. Test Scripts Execution
  21. Requirement Traceability Matrix Record
  22. Installation Qualification, Operational Qualification, Performance Qualification Report
  23. Discrepancy Form
  24. Discrepancy Log
  25. Infrastructure Qualification Protocol & Report
  26. Data Migration Plan
  27. Signature Identification Log
  28. Risk Assessment Report
  29. System specific Business & Technical SOPs
  30. Validation Summary Report
  31. System Release Certificate
  32. Notification for Go live
  33. Change Control Closure Form

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Final Checklist which made your Computer System Validation Documents Preparation & Review Easy

Data Integrity app for Pharma Compliance

In Earlier post we understood what is System Release Certificate (SRC) in computer system validation?

Now in this article we are going to understand Checklist which useful for Computer System Validation Documents Preparation & Review.

The checklist items provide a frame of reference for users and auditors to better determine potential compliance issues with computer system validation.

All items in the checklist should be checked effectiveness of CSV for individual systems, especially where those systems use different control measures.

This checklist will enable you to systematically assess the strengths and weaknesses of a computer system validation using a uniform approach.

This checklist can be used to evaluate potential validation contract vendors/suppliers (front cover letter included).

This checklist was created in line with regulatory requirements of your computer system validation such as FDA 21 CFR Part 11 Electronic records and electronic signatures.

References will be provided for each checklist item to indicate where the requirement comes from.

Checklist for your CSV program:

  1. Change Control Initiation
  2. URS Initiation
  3. Project Plan (schedule)
  4. Change Control Approval
  5. GxP Assessment & System Categorization
  6. System Level Risk Assessment
  7. Vendor Survey
  8. Vendor Onsite Audit
  9. Vendor Audit Report
  10. URS Finalization
  11. Project Validation Plan
  12. Training Records
  13. Functional Specification
  14. Design Specification
  15. Requirement Traceability Matrix Initiation
  16. Functional Level Risk Assessment
  17. Configuration Specification
  18. Software Code Review
  19. Protocol Installation Qualification, Operational Qualification & Performance Qualification
  20. Test Scripts Execution
  21. Requirement Traceability Matrix
  22. Report Installation Qualification, Operational Qualification & Performance Qualification
  23. Discrepancy Form & Its Log
  24. Infrastructure Qualification Protocol & Report
  25. Data Migration Plan
  26. Signature Identification Log
  27. Risk Assessment Report
  28. System Specific Business & Technical SOPs
  29. Validation Summary Report
  30. System Release Certificate
  31. Notification for Go live
  32. Change Control Closure
  33. System Retirement & Decommissioning

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  • Best Practices for CSV.
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What is System Release Certificate (SRC) in computer system validation?

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In Earlier post we understood What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation?

Now in this article we are going to understand what is System Release Certificate (SRC) in computer system validation.

What is System Release Certificate (SRC):

System Release Certificate (SRC) is authorizes the release of System for use in the Production Environment at Location for the users in the department.

The objectives of this SRC are to certify that System has been successfully validated and can be used by the users in the department at Location.

It is essential because it confirms that all project/system has been completed as per regulatory standard mentioned in project plan.

This certificate provides confirmation that all activities specified in the validation plan have been completed & all acceptance criteria have been met and the software is ready for deployment.

All system-related documents/procedures will be provided, developed and/or will be revised before SRC in order to ensure that the use, administration, and maintenance of the system will be properly performed during Operational/Maintenance Phase of the System Life Cycle (SLC).

System Release Certificate contains System/Application Name, version No & Location where system use.

Release the system in the Production Environment for use by the users by developing, approving, and issuing the System Release Certificate.

This SRC for the Project /System indicates that the system has been successfully validated and released for use in the Operating Environment to the users in the respective Department.

Further, this SRC indicates that the Project/System will subsequently be used, administered, and maintained during Operational/Maintenance Phase of the System Life Cycle (SLC).

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What is Validation Master Plan, Its Content & Regulatory Requirement in Computer System Validation?

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In Earlier post we understood How to Conduct a GAP Assessment in Computer System Validation process.

Now in this article we are going to understand What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation?

What is Validation Master Plan?

EU GMP Vol. 4 Annex 15 says: “The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent documents.”

Validation Master Plan helps give sense and organization to your validation efforts, and an understanding of how it supports the goals of your facility. It makes auditors happy because they are used to seeing validation plans.

Top management is not always aware of the real requirements for validations and qualifications. They generally focus on finances and business processes. The Validation Master Plan helps educate management by presenting a summary assessment of what it will take to get the job done.

The Validation Master Plan also referenced as “VMP” is one of the key documents in the GMP (Good manufacturing practice) regulated pharmaceutical industry.

According to GMP requirements, manufacturers should plan qualification and validation within a product lifecycle. Any changes in the facilities, equipment, utilities, and process affecting product quality should be formally documented and the impact on validated status should be assessed.

VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. Critical computerized systems should be validated.

The Validation Master Plan is a summary of validation strategy. The purpose of the Validation Master Plan is to document the compliance requirements for the site and to ensure that sufficient resources are available for validation projects.

The validation master plan is a document where key elements of the qualification and validation program are identified and documented.

VMP justifies the strategy, documenting the necessary program. It’s a “high level” document which provides a written program to ensure a continuing state of validation. We can say VMP is achieving and maintaining qualified facility.

All Validation program is mention in VMP.  In simple language we can describe the major element of “Validation program”-

Validation Master Plans should be approved by the head of Site Quality, plus other senior department heads as appropriate. Senior management approval is necessary for Validation Master Plans because their support is essential for the success of the plan.

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The validation Master Plan helps to Determine:

  • Systems, equipment, methods, facilities, etc., that are in the scope of the plan
  • List of tests
  • Control points
  • Sampling frequency and location
  • Frequency of the re-qualification

Validation Master Plan must Include:

  • Qualification and validation policy
  • General validation risk mitigation strategy
  • A list of all validation activities & any parallel Validation Plans 
  • A list of personnel responsible for the VMP, SOPs and protocols
  • A list relevant validation reports and documents
  • A list of personnel (roles) who provide approval
  • Current validation status for the systems within the project scope
  • The organizational structure including roles and responsibilities for conducting qualification and validation
  • Summary of the facilities, equipment, systems, processes on-site and the qualification and validation status
  • Compliance requirements for validation, including how the validated state will be maintained
  • Schedule of validation activities
  • Change control and deviation management for qualification and validation
  • Guidance on developing acceptance criteria
  • References to existing documents
  • The qualification and validation strategy, including re-qualification
  • Required validation Deliverable

Content of Validation Master Plan:

  • Title page and authorization (approval signatures and dates)
  • Table of contents
  • Abbreviations and glossary
  • Validation policy
  • Philosophy, intention, and approach to validation
  • Roles and responsibilities of relevant personnel
  • Resources to ensure validation is done
  • Outsourced services (selection, qualification, management through life cycle)
  • Deviation management
  • Change control
  • Risk management principles
  • Training
  • Scope of validation
  • Documentation required in qualification and validation such as procedures, certificates, protocols, and reports
  • Premises qualification
  • Utilities qualification
  • Equipment qualification
  • Process validation
  • Cleaning validation
  • Personnel qualification such as analyst qualification
  • Analytical method validation
  • Computerized system validation
  • Establishing acceptance criteria
  • Life-cycle management including retirement policy
  • Re-qualification and Revalidation
  • Relationship with other quality management elements
  • Validation matrix
  • References

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How to Conduct a GAP Assessment in Computer System Validation process.

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In Earlier post we understood What is Validation Summary Report in Computer system Validation

Now in this article we are going to understand How to Conduct a GAP Assessment in Computer System Validation process.

What is GAP Assessments?

GAP is nothing but difference between actual state and desired state.

A way to compare current conditions & practices in order to identify gaps and areas in need of improvement with regards to compliance to the relevant standards.

It  is the procedure to manage an organization to not only correct or improve their processes, but also identify processes which are in necessity of upgrade.

Gap Assessment is one of the best procedures to help lead an organization to not only improve their processes, but recognize which processes are in need of improvement.

The aim of GAP Assessment in Computer System Validation is to identify the gap between company’s existing procedures, practices and policies with respect to relevant regulatory guidelines and compliance standards.

The GAP Assessment involves evidence and it lays down the variance between requirements and existing strength.

A GAP Assessment is usually conducted before the validation activity starts. Effective GAP analysis helps maintaining and developing better compliance.  

Gap Assessment may have different purposes:

  • To determine if a system to be purchased will comply with Part 11 before purchasing it
  • To efficiently incorporate Part 11 compliance into your validation effort
  • To assess existing systems for Part 11 compliance
  • To remediate existing systems for Part 11 compliance

 

Steps involve in GAP Assessment:

  • Identify the requirements for computer system/software
  • Make a list of requirements this is usually in the form of questions.
  • Identify the risk of computer system/software against the requirements
  • The Gap Assessment questions are turned into action statements
  • These action statements formulate remedial actions which will fill in the gaps Develop plans to address the gaps.
  • Ensure that required documents & SOPs/Manuals are available
  • Ensure that the specifications of computer system/software are according to requirements
  • Mitigate the risk of computer system/software against the requirements
  • To verify that computer system/software meets compliance standards
  • Review of all current practices,

GAP Assessment benefits organizations in getting comprehensive approach to organization or respective function, this results in decreased project cost.

Strategy for Bridging the GAP

  • Clearly define accountabilities and responsibilities.
  • Monitor practices and tools for computerized system.
  • Revision control for reanalysed data.
  • Enforce operational checks to verify user permissions.
  • Enforce sequence of permitted steps according to a defined workflow.
  • Use predefined workflows.
  • Define “built-in” checkpoints within the systems.
  • Awareness – all levels are fundamental parts of the quality system
  • Qualify analytical instruments before using them.
  • Guidance for Industry 21 CFR Part 11, Electronic Records and Electronic Signatures.
  • Document periodic review results, any gaps identified and remedial action thereafter.
  • Annual assessment of laboratory process control.

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What is Validation Summary Report(VSR) in Computer System Validation

Data Integrity app for Pharma Compliance

In Earlier post we understood How to handle Discrepancies during Computer System validation?

Now in this article we are going to understand What is Validation Summary Report in Computer system Validation

What is Validation Summary Report:

Validation Summary Reports provide an overview of the entire validation project. It is summary of all planned activities, their success or failure, and any deviations from the expected results or plans encountered.

Once the summary report is signed, the validation project is considered to be complete. When regulatory auditors review validation projects, they typically begin by reviewing the summary report.

When validation projects use multiple testing systems, some organizations will produce a testing summary report for each test protocol, then summarize the project with a final Summary Report.

The purpose of a Validation Summary Report (VSR) is to provide a concise overview of the entire validation effort and the results obtained. Additionally, the approval of the VSR authorizes the release of the system for operational use.

The validation summary report brings together all of the documentation collected throughout the life cycle and presents a recommendation for management approval that the system is validated and should be released for operational use.

The amount of detail in the reports should reflect the relative complexity, business use, and regulatory risk of the system. The report is often structured to mirror the validation plan that initiated the project.

The collection of documents produced during a validation project is called a Validation Package. Once the validation project is complete, all validation packages should be stored according to your site document control procedures.

The report is reviewed and signed by the system owner and Quality. Summary reports should be approved by the System Owner and Quality Assurance.

 

Validation Summary Report should address the following elements:

  1. Identification of the system subject to validation.
  2. An inventory of all the deliverables generated during the validation effort including the document identifier and the approval date.
  3. A summary of the results obtained during testing along with a discussion of any non-conformance encountered, their impact, and how they were resolved.
  4. Details of any deviations from the Validation Plan and the impact of these occurrences on the validation project.
  5. A list of any outstanding issues along with any known system limitations.
  6. A statement of acceptance allowing for the release of the system.

 

The validation summary report should include:

  1. A description of the validation project, including the project scope
  2. All test cases performed, including whether those test cases passed without issue
  3. All deviations reported, including how those deviations were resolved
  4. A statement whether the system met the defined requirements

Download our Free Data Integrity App to access more related content.

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

Innov@tive App
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