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					Title        Non-Product Retrospective CSV Assessment, <SYSTEM NAME>              Page        1 of 16
Doc Type     General Document Record                                              Doc ID      33xxxxx
Doc State    Preliminary       State Date             xx/xx/2009                  Doc Rev     A
QS Parent


This document is electronically signed in the Xxx-Control, Inc. Product Lifecycle Management
(PLM) System. Approvals can be obtained from the PLM system which displays the selected
approvers, their approval roles, and approval dates.


PROPRIETARY AND CONFIDENTIAL DOCUMENT FOR XXX-CONTROL, INC. USE ONLY. This
document is property of Xxx-Control and may not be used, reproduced, published or disclosed to
others without authorization from Xxx-Control.




                                                     Owner                             (Meta-data = Owner)

Attachments (Optional):                                            Qty    Pages       Page Sequencing




                                             Change Description
New GDR 3301785 for the CAPA - SmartCAPA, Smart Complaints non-product retrospective Computer System
Validation assessment performed based on Quality Plan 3300400.
Title            Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                 Page         2 of 16
Doc Type         General Document Record                                                 Doc ID       33xxxxx
Doc State        Preliminary       State Date               xx/xx/2009                   Doc Rev      A
QS Parent

1.      Purpose
        Provide documented evidence of successful completion of the retrospective computer system validation
        assessment for the non-product system CAPA SmartCAPA and Smart Complaints Apps of the
        SmartSolve System used by Xxx, Inc. in Xxx, WA.

2.      Scope
        Validation scope of existing systems or validation mitigation identified for existing systems is out of scope.

3.      Approach
        This non-product retrospective computer system validation (CSV) assessment is being performed
        based on the current revision of Computer System Validation Quality Plan, GDR 3300400. The
        workflow documented in this retrospective assessment worksheet which was based on the process
        detailed in 3300400 has been refined and improved and provides the correct workflow required to
        properly perform the retrospective CSV assessment for non-product systems at Xxx.

4.      References
        DOCUMENT              REVISION           DOCUMENT TITLE
           ID
                                   A             Xxx System Validation Methodology (PSVM) Transition Plan
                                   A             Computer System Validation Quality Plan
                                                 Inventory of Xxx-Control Non Product Computer Systems which
                                  C
                                                 Support the Quality System
                                  F              Design Controls Quality Procedure
                                  D              Calibration Program Work Instruction
                                  D              Non-Product Software Validation Quality Procedure
                                  E              Test Validation And Qualification Work Instruction
                                  B              Categorization and Assessment Work Instruction
                      Document                                      Document Title
                       Number
                   7000000              Xxx-Control Business and Quality Management Manual
                   7000005              Statistical Techniques Quality Procedure
                   7000035              Management Review Work Instruction
                   7000036              Product Review Board Work Instruction
                   7000063              Design Verification Work Instruction
                   7000074              Master Observation Log (MOL) Work Instruction
                   7000075              Product Safety Risk Management Work Instruction
                   7000085              Corrective and Preventive Action Work Instruction
                   7000086              Quality Review Board Work Instruction
                   7000090              Correction and Removals Quality Procedure
                   7000130              Supplier Maintenance Work Instruction
                   7000334              Operational Process Improvement System Work Instruction


5.      Conclusion
Title           Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                 Page         3 of 16
Doc Type        General Document Record                                                 Doc ID       33xxxxx
Doc State       Preliminary       State Date               xx/xx/2009                   Doc Rev      A
QS Parent

        The retrospective CSV assessment for this system yielded the following results:
               The system was confirmed to be identified in the current non-product inventory, PDR-13574.
               Validation Applicability and Criticality Rating determined in accordance with 7000351 Appendix
                A & B was confirmed as NOT previously completed for this system. Refer to executed Tables 2
                & 3A attached to this document for the completed Validation Applicability and Criticality Rating.
               The Criticality Rating identified for the system was confirmed to be at the current Priority Level
                High per Master Validation Plan (QP3300400).
               Tables 2 & 4 attached to this GDR provide evidence that the system requires validation activities.
               The system was confirmed to have been previously validated.
               The system was not validated previously per 7000272, Revision D.
               The system was verified as having validation mitigation previously performed as part of M120.
               The system was confirmed to have been previously validated based on M120 Quality Plan.

        Based on the results summarized above, the retrospective CSV assessment of this system is deemed by
        Xxx to be satisfactory and complete.
Title               Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                                           Page           4 of 16
Doc Type            General Document Record                                                                           Doc ID         33xxxxx
Doc State           Preliminary       State Date                             xx/xx/2009                               Doc Rev        A
QS Parent

WORKFLOW 1: RETROSPECTIVE VALIDATION ASSESSMENT FOR CAPA SMARTCAPA AND SMART COMPLAINTS APPS OF THE
SMARTSOLVE SYSTEM (SEE TABLE 1 FOR DETAILS)
                                                                                                           NOTE: Refer to 3300400,
                                                                                 Start                     Appendix A, Figure 1



                                                                                                                  Create Quality Record
                                    Was 7000351                              Is the system                        of 7000351 Appendix
                                   Appendix A & B                             identified in                 No    A & B (Tables 2 & 3 of
                                  previously done?              Yes          PDR-13574?                            this GDR); include in
                 No
                                                                                                                  PDR-13574 inventory.

      Perform a WI 7000351              Yes
       Validation Applicability
        & Criticality Rating
            assessment:
      Tables 2, 3A and 3B (if
      applicable) of this GDR.                                                             Criticality Rating
                                                                       Yes                   at or above
                                                                                           current Priority?

                                                 Validation Required?                                No
                                                *See Workflow 2/Table 4 &
                                                 see Table 2 of this GDR
                                                                                         Delay until Priority
                                                                                          Level is lowered
                                                                Yes
                      No

                                                     Has the system
                                                     been previously                 Yes
               Create Quality                          validated?
             Record to document
Yes                                                                                      Was the system
               “No Validation
             Required” rationale                                                      validated to Rev D or                  Yes
                                                                                       higher of 7000272?


                                                                                                      No


                                                                                        Was the system
                                                             No
                                                                                       validation mitigated                  Yes
                                                                                        as part of M120?


                                                                                                      No


                                                                                       Was the system
                                                                                      validated based on                     Yes
                                                                                      M120 Quality Plan?


                                                                                                    No

                                                                                      Validate the system            Retrospective
                                                                                        or replace per              Assessment of
                                                                                       7000272 Rev D                System: DONE




                                                                                           STOP HERE (for the purpose of this GDR)
                                                                                No
                                                     More applications                         Set Priority to next lower Level
                                                     at current Priority                                 and repeat.
                                                          Level?
Title            Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                      Page         5 of 16
Doc Type         General Document Record                                                      Doc ID       33xxxxx
Doc State        Preliminary       State Date                   xx/xx/2009                    Doc Rev      A
QS Parent

TABLE 1: RETROSPECTIVE VALIDATION ASSESSMENT OBJECTIVE EVIDENCE FOR CAPA SMARTCAPA AND SMART COMPLAINTS
APPS OF THE SMARTSOLVE SYSTEM
Decision Point           Description                                         Assessment Results
Start                    Performed On:                                       January 28th 2009
                         Performed By:                                       Emma Miller and Kevin Wall
                         System Name:                                        CAPA SMARTCAPA AND SMART COMPLAINTS
                                                                             APPS OF THE SMARTSOLVE SYSTEM
                           Functional Owner:                                 Kevin Wall
                           Contact:                                          Kevin Wall
Is the system identified If “Yes”, proceed to next decision point.           Yes
in the current revision of Else, create Quality Record of 7000351
PDR-13574?                 Appendix A & B (Tables 2 & 3 of this GDR);
                           include in PDR-13574 inventory.
Was 7000351 Appendix If “Yes”, proceed to next decision point.              No
A & B previously done? Else, execute WI 7000351 Appendix A and
                           Appendix B (Tables 2, 3 of this GDR).
Criticality Rating at or   If “Yes”, proceed to next decision point.        Yes
above current Priority? Else, delay until Priority Level is lowered.
Validation Required?       Refer to a previously executed Appendix A of
                           WI 7000351 if found, or refer to Table 2 of this
                           GDR executed per above.
                           Also, see Workflow 2 and Table 4 of this GDR
                           for the documented results of the Validation
                           Required Decision Tree.

                         Based on results of Table 2 and Table 4:
                         If ‘validation required’ results in a “Yes”, then
                         proceed to next decision point.
                         Else, document the “No Validation Required”
                         rationale (e.g., Table 4 below).
Has the system and/or    If “Yes”, proceed to next decision point.           Yes (SmartSolve System) includes the
process been             Else, proceed to assessment disposition.            applications for: SmartCAPA & Smart
previously validated?                                                        Complaints.
                                                                             Bounding Process
Was the system          If “Yes”, then proceed to assessment
validated to Rev D or   disposition (“Retrospective Assessment of
higher of 7000272?      System: DONE”)
                        Else, proceed to the next decision point.
Was the system          If “Yes”, then proceed to assessment
validation mitigated as disposition (“Retrospective Assessment of
part of M120?           System: DONE”)
                        Else, proceed to the next decision point.
Was the system          If “Yes”, then proceed to assessment
validated based on      disposition (“Retrospective Assessment of
M120 Quality Plan?      System: DONE”)
                        Else, proceed to disposition (“Validate the
                        system or replace per 7000272, Rev D”).
Assessment disposition Retrospective Assessment of System: DONE
Assessment disposition Validate the system or replace per 7000272
                        Rev D.

(E-Signature captured in PLM system)                                                               (Date on file)
                                                                                                                   th
Retroactive Assessment Performed By: Emma Miller                                                   Date January 28
                                                                                                   2009

(E-Signature captured in PLM system)                                                               (Date on file)
                                                                                                                   th
Reviewed and Approved By System Owner/Contact or Designate: Kevin Wall                             Date January 28
Title        Non-Product Retrospective CSV Assessment, <SYSTEM NAME>   Page        6 of 16
Doc Type     General Document Record                                   Doc ID      33xxxxx
Doc State    Preliminary       State Date              xx/xx/2009      Doc Rev     A
QS Parent

                                                                          2009

(E-Signature captured in PLM system)                                      (Date on file)
Reviewed and Approved By Quality Unit (CQS Owner): Matt Quinn             Date
Title            Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                       Page          7 of 16
Doc Type         General Document Record                                                       Doc ID        33xxxxx
Doc State        Preliminary       State Date                    xx/xx/2009                    Doc Rev       A
QS Parent

TABLE 2: APPLICABILITY OF VALIDATION       PER   7000272   FOR   CAPA SMARTCAPA      AND   SMART COMPLAINTS APPS       OF THE
SMARTSOLVE SYSTEM
(*REFER TO 7000351, APPENDIX A)

Yes / No?       Criteria
Yes             Is the system used to manage or control a manufacturing and/or testing material or process that has a
The Data        direct impact on product quality attributes such as:
System is                                              Identity      Safety
utilized for
                                                       Quality       Effectiveness
quality
                                                       Durability    Performance
attribute
                                                       Reliability   Data integrity
reporting
Yes
It is used to
generate
holds and       Is the system used to generate data used to release raw materials, components or finished
stop ship of    products?
non-
conforming
material

                Is the system used to manage, control or provide input into any aspect of the Quality System? The Quality
                System includes:
Yes
The process Check All That Apply
of managing     Laboratory Systems
data from:      Design Controls
OPI, QRB,     X Document Controls
Corrective      Training
and             Purchasing
Preventive    X Identification and Traceability
Action          Environmental Controls
(CAPA)        X Production and Process Controls
Process
                Maintenance and Calibration Activities
Bounding or
              X Acceptance Activities
reporting,
AND           X Nonconforming Product
SmartSolve    X Corrective and Preventive Action
System apps     Complaint Handling/Adverse Event Reporting
that consists   Labeling and Packaging Control
of              Handling, Storage, Distribution and Installation, or Servicing of components and products
SmartCAPA,      Internal Audit Tracking and Management
Smart           Clinical Data Management
Complaints    X Management Review
                Validation (Process / Material)
                Statistical Controls

                Is the system used to generate or store data that will become a part of the Design History File, Device
Yes             Master Record, Device History Record or a Regulatory submission (such as, but not limited to: IDE,
                510(k), PMA)?
                Is the system being used to indirectly or directly generate process, transfer or store other QSR/GxP
Yes
                regulated information that may be required by regulatory agencies?

 (E-Signature captured in PLM system)                                                               (Date on file)
 Retroactive Assessment Performed By: Emma Miller                                                   Date January 28,
                                                                                                    2009

 (E-Signature captured in PLM system)                                                               (Date on file)
 Reviewed and Approved By System Owner/Contact or Designate: Kevin Wall                             Date
                                                                                                    January 28, 2009
Title        Non-Product Retrospective CSV Assessment, <SYSTEM NAME>   Page        8 of 16
Doc Type     General Document Record                                   Doc ID      33xxxxx
Doc State    Preliminary       State Date              xx/xx/2009      Doc Rev     A
QS Parent

(E-Signature captured in PLM system)                                      (Date on file)
Reviewed and Approved By Quality Unit (CQS Owner): Matt Quinn             Date
Title               Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                   Page         9 of 16
Doc Type            General Document Record                                                   Doc ID       33xxxxx
Doc State           Preliminary       State Date               xx/xx/2009                     Doc Rev      A
QS Parent

TABLE 3A: EVALUATION OF CAPA SMARTCAPA AND SMART COMPLAINTS APPS OF THE SMARTSOLVE SYSTEM FOR HIGH
CRITICALITY RATING
(*SEE 7000351, APPENDIX B)
If one or more of the following assessments below result in a “Yes”, then “High Criticality” rating applies (STOP).
Else, continue to Table 3B below.
Criticality Rating       Description                                                                       APPLIES?
                                                                                                           (YES / NO)
                         1. The system/process makes pass/fail or go/no-go decisions about the             Yes
                         product with Production and Process Control, Product Acceptance, or Design
                         Verification. Examples: End Item Test, Design Assurance Test Systems
                         2. The system is used to write to the product to configure functionality, set
        High             parameters, or perform diagnostics. Examples: Configuration Loader, Service
                         Defib Calibration programs
                         3. The system is an enterprise scope application that supports the Quality        Yes
                         System across multiple Quality System elements. Examples: Pilgrim, eCentral,
                         Mfg/Pro, Service Application, MetCAL

TABLE 3B: EVALUATION OF CAPA SMARTCAPA AND SMART COMPLAINTS APPS OF THE SMARTSOLVE SYSTEM FOR MEDIUM OR
LOW CRITICALITY RATING
(*SEE 7000351, APPENDIX B)
Variable                 Assessment Result                                                   Applies?     Impact Score
                         (NOTE: Only one ‘Assessment Result’ per ‘Variable’ will result in a (Yes / No)
                         “Yes”)
Scope of Use             Local use                                                          Yes           3
                             Impact score = 1
                         Functional                                                         Yes
                             Impact score = 2
                         Multi-Functional                                                   Yes
                             Impact score = 3
Traceability to a        Not directly traceable to a Quality System Requirement             Yes           3
Quality System               Impact score = 1
Requirement              Traceable to a Quality System Requirement                          Yes
                             Impact score = 3
Degree of                Essentially used 100% out of the box                               No            4 or 5 lets look
Customization                Impact score = 1                                                             at the val plan
                         Custom Configuration Using Out of the Box tools                    Yes           and summary
                             Impact score = 2                                                             report Doc#
                                                                                                          must attach to
                         Configured and Customized                                          Yes
                                                                                                          this record as
                             Impact score = 3
                                                                                                          it is Required
                         Mostly Customized, Complex Configuration                           Yes           for evidence
                             Impact score = 4
                         Custom
                             Impact score = 5
                                                                                  TOTAL IMPACT SCORE: 36 at least
           NOTE: Multiply the Impact Scores from each variable together to obtain a Total Impact Score.
                                                                                CRITICALITY RATING: Greater than 12
                                                           Medium Criticality = Total Impact Score >12
                                                               Low Criticality = Total Impact Score ≤12

 (E-Signature captured in PLM system)                                                              (Date on file)
 Retroactive Assessment Performed By: Emma Miller                                                  Date
                                                                                                               th
                                                                                                   January 28 2009
 (E-Signature captured in PLM system)                                                              (Date on file)
 Reviewed and Approved By System Owner/Contact or Designate: Kevin Wall                            Date
                                                                                                               th
                                                                                                   January 28 2009
 (E-Signature captured in PLM system)                                                              (Date on file)
Title        Non-Product Retrospective CSV Assessment, <SYSTEM NAME>   Page      10 of 16
Doc Type     General Document Record                                   Doc ID    33xxxxx
Doc State    Preliminary       State Date              xx/xx/2009      Doc Rev   A
QS Parent

Reviewed and Approved By Quality Unit (CQS Owner): Matt Quinn             Date
Title                     Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                   Page           11 of 16
Doc Type                  General Document Record                                                   Doc ID         33xxxxx
Doc State                 Preliminary       State Date               xx/xx/2009                     Doc Rev        A
QS Parent

TABLE 3C: DETERMINATION OF THE RISK CLASS FOR CAPA SMARTCAPA AND SMART COMPLAINTS APPS OF THE SMARTSOLVE
SYSTEM
(FOR INFORMATIONAL PURPOSES ONLY)

                                                   DEGREE OF CUSTOMIZATION
                                                   (Software Class)
                                                   Low               Moderate                           High
                                                   (GAMP Class 3)    (GAMP Class 4)                     (GAMP Class 5)
                  High                             Risk Class 2      Risk Class 1                       Risk Class 1
   SCOPE OF USE




                  (Multi-Functional/Enterprise)
                  Moderate                         Risk Class 3               Risk Class 2              Risk Class 1
                  (Functional/Single QS Element)
                  Low                              Risk Class 3               Risk Class 3              Risk Class 2
                  (Local Use)

                                                   GAMP Class identified for the system: Risk Class 1
                                                   Scope of Use identified for the system: Multi Functional


                                                   Resulting Risk Class for the system: Risk Class 1



TABLE 3D: DETERMINATION OF THE CRITICALITY RATING FOR CAPA SMARTCAPA AND SMART COMPLAINTS APPS OF THE
SMARTSOLVE SYSTEM
(FOR INFORMATIONAL PURPOSES ONLY)

                                                   TRACEABILITY TO A QUALITY SYSTEM REQUIREMENT
                                                   (Quality Decision or Regulated Record)
                                                   Not Traceable          Indirectly Traceable Directly Traceable


                  Risk Class 1                     Medium Criticality         High Criticality          High Criticality


                  Risk Class 2                                                                          High Criticality
   RISK CLASS




                                                   Low Criticality            Medium Criticality


                  Risk Class 3                     Low Criticality            Low Criticality           Medium Criticality


                                                   Risk Class identified for the system: High Criticality
                                                   Traceability to a QS Requirement: 21 CFR parts: 11 electronic Records &
                                                   Signatures, 211 sub part J Records & Reports, 820


                                                   Resulting Criticality Rating for the system: High Criticality
Title         Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                        Page      12 of 16
Doc Type      General Document Record                                                        Doc ID    33xxxxx
Doc State     Preliminary       State Date                  xx/xx/2009                       Doc Rev   A
QS Parent

WORKFLOW 2: VALIDATION REQUIRED DECISION TREE FOR CAPA SMARTCAPA AND SMART COMPLAINTS APPS OF THE
SMARTSOLVE SYSTEM
(SEE TABLE 4 FOR DETAILS)


                                                    Start         NOTE: Refer to 3300400,
                                                                  Appendix A, Figure 2



                                             Is the system                       See Design Controls
                                           Product Software?             Yes
                                                                                      7000004


                                               No


                                             Is the system                          See 7000327,
                                             Manufacturing               Yes
                                                                                      7000155
                                                  Test?


                                               No


                                              Is the system                          See 7000272
                                             installed and in            No
                                            operational use?


                                               Yes

                                                                                  Create record
                                           Is there a record of                 authorizing use of
                                            first authorization          No          system
                                                  of use?

                                               Yes


                                           Is the system used
                                            to make a Quality                  Yes
                                            decision directly?

                                               No



                                         Does the system create
                                           DMR, DHF, QSDs,                       System requires
                                          Complaints, DHRs or                       validation
                                         other Quality Records?



                                Yes


              Downstream                   Is application Low
No          Inspection of the   No           Risk based on                     No
                record?                         usage?

                                               Yes

                                            System does not
                                Yes
                                            require validation
Title            Non-Product Retrospective CSV Assessment, <SYSTEM NAME>                         Page         13 of 16
Doc Type         General Document Record                                                         Doc ID       33xxxxx
Doc State        Preliminary       State Date                    xx/xx/2009                      Doc Rev      A
QS Parent

TABLE 4: VALIDATION REQUIRED DECISION TREE OBJECTIVE EVIDENCE FOR CAPA SMARTCAPA AND SMART COMPLAINTS
APPS OF THE SMARTSOLVE SYSTEM
Decision Point              Description                                       Assessment Results
Start                       Performed On:                                     January 28, 2009
                            Performed By:                                     Emma Miller
                            System Name:                                      CAPA, Smart CAPA, Smart Complaints
                            Functional Owner:                                 Kevin Wall
                            Contact:                                          Kevin Wall
Is the system Product       If “Yes”, then remove system from Non-Product No
Software?                   inventory, document as Product Software, see
                            Design Controls (WI 7000004) and STOP
                            (return to Table 1).
                            Else, proceed to next decision.
Is the System               If “Yes”, then remove system from Non-Product No
Manufacturing Test?         inventory, see WI 7000155 and 7000327 and
                            STOP.
                            Else, proceed to next decision point.
Is the system installed If “Yes”, proceed to next decision point.             Yes
and in operational use? Else, system requires validation per WI
                        7000272 prospectively and STOP.
Is there a record of first If “Yes”, proceed to next decision point.          Attach either a VSR, Val Plan, Change control
authorization of use?      Else, create a record authorizing use of the       record that documents the fitness of intended
                           system. Upon completion of the required use        use.
                           authorization documentation, then proceed to
                           next decision point.
Is the system used to   If “Yes”, this system requires validation per         Yes
make a Quality decision 7000272 and STOP (return to Table 1).
directly?               Else, proceed to next decision point.
Does the system create      If “Yes”, proceed to next decision point.         Yes
DMR, DHF, QSDs,             Else, then this system does NOT require
Complaints, DHRs or         validation and STOP (return to Table 1).
other Quality Records?
Is there a downstream       If “Yes”, this system does NOT require
inspection of the record    validation and STOP (return to Table 1).
(if applicable)?            Else, proceed to next decision point.
Is the application          If “Yes”, this system does NOT require            No
identified a “Low Risk” *   validation and STOP (return to Table 1).
system based on use?        Else, this system requires validation per
*NOTE: See Table 1.         7000272 and STOP (return to Table 1).
Decision Tree               System requires validation.
disposition.

(E-Signature captured in PLM system)                                                                 (Date on file)
Retroactive Assessment Performed By: Emma Miller                                                     Date January 28,
                                                                                                     2009

(E-Signature captured in PLM system)                                                                 (Date on file)
Reviewed and Approved By System Owner/Contact or Designate: Kevin Wall                               Date January 28,
                                                                                                     2009

(E-Signature captured in PLM system)                                                                 (Date on file)
Title        Non-Product Retrospective CSV Assessment, <SYSTEM NAME>   Page      14 of 16
Doc Type     General Document Record                                   Doc ID    33xxxxx
Doc State    Preliminary       State Date              xx/xx/2009      Doc Rev   A
QS Parent

Reviewed and Approved By Quality Unit (CQS Owner): Matt Quinn             Date

				
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