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Validation Change Control SOP

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					Title     Validation Change Control SOP
Version   Status                                Date           Page
1.0       Commercial in Confidence              04-Aug-2006    1 of 13




           Validation Change Control SOP




                                     Document No:   SOP_0900
                                     Prepared by:   David Brown
                                     Date:          04-Aug-2006
                                     Version:       1.0
Title         Validation Change Control SOP
Version       Status                                   Date          Page
1.0           Commercial in Confidence                 04-Aug-2006   2 of 13



                               Document Approval

Name                    Role             Date           Signature
David Brown             Author           04-Aug-2006




                               Document Control


Version       Author             Date           Description
1.0           David Brown        04-Aug-2006    Version 1
Title               Validation Change Control SOP
Version             Status                                                                    Date                          Page
1.0                 Commercial in Confidence                                                  04-Aug-2006                   3 of 13



                                                              Table of Contents



1      Introduction ............................................................................................................................ 4
    1.1       Purpose ........................................................................................................................... 4
    1.2       Scope ............................................................................................................................... 4
    1.3       Definitions ...................................................................................................................... 4
    1.4       Responsibility ................................................................................................................. 5
    1.5       References ...................................................................................................................... 6
2      Procedure ................................................................................................................................ 7
    2.1     Origination, Review and Approval of VCC Forms .................................................... 7
      2.1.1     Origination of VCC Form ....................................................................................... 7
      2.1.2     Definition of the Change ......................................................................................... 7
      2.1.3     Changes to Equipment, Processes, Systems, or Utilities ......................................... 8
    2.2       Assessment ..................................................................................................................... 9
    2.3       Cancelling a VCC Form .............................................................................................. 10
    2.4       Completion of the VCC Package................................................................................ 10
    2.5       Testing During Change Control ................................................................................. 10
    2.6       Document Records and Archives ............................................................................... 11
3      Appendix 1 – Changes requiring VCC ................................................................................ 12
Title     Validation Change Control SOP
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1          Introduction

1.1        Purpose


           The purpose of this procedure is to describe the responsibilities,
           sequence of events, and documentation involved in controlling
           change and maintaining the validation status of validated
           systems/processes.
           Validation Change Control (VCC) is a formal system for:
                  Obtaining approval to make the change;
                  Reporting planned and emergency changes to validated
                   systems/processes;
                  Evaluating impact of these changes on the validation
                   status of systems/processes, and;
                  Final summary and approval of documentation supporting
                   validation requirements.

1.2        Scope
           Originating Department/Section: Validation Group
           This SOP applies to all computer systems requiring validation.

1.3        Definitions
           Change or modification is defined as the deletion,
           modification, or decommissioning of validated computer
           systems. Within this procedure, a change or modification is
           considered equivalent to any improvements, enhancements,
           removal, relocation (except portable equipment) or
           configuration changes to validated systems/processes. Routine
           maintenance is not considered change under this SOP.
           Routine maintenance is defined as regularly scheduled setup,
           preventative maintenance inspections, adjustments, lubrication,
           and/or replacements of identical or functionally equivalent
           component parts to maintain and assure maximum equipment
           efficiency.
           VCC Package is the completed set of documentation collected
           to meet all of the validation requirements of a Validation Change
           Control as described in the VCC assessment.
Title     Validation Change Control SOP
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           Client – the business system owner is typically the „line‟
           manager responsible for the business process where the
           computer system will be used.
           Validation Group – the group responsible for ensuring that
           computer systems are implemented and maintained in a
           validated state.
           IT Group – the group responsible for development, operation,
           and maintenance of computer systems.

1.4        Responsibility
           The IT group is responsible for:
                  Notifying Validation when a change is planned.
                  Planning and executing the change.
                  Performing applicable test(s) required by the change (e.g.
                   pressure test, calibration, etc.).
                  Documenting the change by updating applicable
                   drawings, specifications, and SOPs.
                  Assessing whether proposed validation work will
                   adequately test intended functionality. Determine that
                   tests are not destructive to equipment or data, are
                   technically feasible, and that references to
                   software/hardware objects are accurate.
                  Ensuring the requested change is consistent with process
                   capabilities and requirements.
                  Approving Validation Change Control Form and Package


           Clients (users) shall be responsible for:
                  Ensuring that the implementation of the change is
                   consistent with Client needs.
                  Identifying and updating all appropriate Client SOPs as
                   required.
                  Assessing whether validation work will adequately test
                   intended functionality.
                  Retraining on systems/processes that are changed as a
                   result of VCCs.
                  Ensuring that validation is notified in a timely manner so
                   that impacted product can be placed on Hold.
Title     Validation Change Control SOP
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                  Implementing the change.
                  Approving Validation Change Control Form and Package


           Validation is responsible for:
                  Assessing the change to determine if the change is in
                   compliance with cGXPs and SOPs.
                  Defining the necessary support documentation to be
                   supplied by the developer or client in response to a
                   modification.
                  Reviewing support documentation to determine if the
                   change is adequately described.
                  Establishing testing requirements or re-qualification
                   (partial or total) and preparing testing protocols
                  Scheduling and directing necessary testing in conjunction
                   with the completion of the modification.
                  Formulating accurate conclusions from test results.
                  Making the test results, validation documents, and
                   support documents available for inclusion in the VCC
                   Package.
                  Approving Validation Change Control Form and Package

1.5        References


           Document ID                Title
           SOP_0100                   Implementation Lifecycle SOP
Title     Validation Change Control SOP
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2          Procedure

2.1        Origination, Review and Approval of VCC Forms

2.1.1      Origination of VCC Form
           For an employee to determine whether a change requires a VCC
           form and to originate a VCC form, documented training on this
           SOP is required. Validation requirements for the change must
           be assessed using this procedure prior to making any change
           to a system. The originator should determine if the equipment
           or system has a validated status. If the system has a validated
           status, refer to Appendix 1 “Changes Requiring a VCC Package”
           to determine what situations require a VCC Form to be
           originated.
           The originator and/or affected area management will normally
           initiate a Validation Change Control (VCC) Form (See document
           template: Template_VCC_0900_01 - Validation Change
           Control). The form will be completed in conjunction with the
           developer if system changes are necessary. This is conducted
           by completing the Description / Rationale of the Change that is
           thorough enough to enable the assessment of validation and
           compliance impact. Alternately, for supported computer
           applications, a Project Request/Concept/Incident form as
           described in SOP SOP_0100 “Implementation Life Cycle” can
           initiate the preparation of a VCC form by the Validation group.


           The originator analyses the change and provides necessary
           input for the VCC Form. Support data, stability information, and
           relevant commentary are incorporated into the Description /
           Rationale. The VCC Form must be submitted to the validation
           group with information typed or written in ink.

2.1.2      Definition of the Change

2.1.2.1    Planned Changes
           Final approval on the VCC Package is required prior to final
           product disposition.
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2.1.2.2    Emergency Changes
           Changes may require assessment and implementation at times
           when a validation representative is not available. An Emergency
           Change represents a change that may be implemented prior to
           review and approval by the validation group if operator safety,
           facility function, or product integrity is at risk. Where the
           Emergency Change must be implemented, the originator must
           notify the Validation group no later than the next business day.
           The originator will submit a VCC form for immediate assessment
           and processing. All Emergency Changes should be given top
           priority and completed as quickly as possible. Completion of the
           Change Control work includes activities through document
           creation and final approval of the VCC Package.

2.1.3      Changes to Equipment, Processes, Systems, or Utilities

2.1.3.1    Changes to Operating Parameters
           Changes made to systems/processes affecting operating
           parameters (critical alert limits, set-points, tuning parameters,
           and alert alarm limits) can be performed without a VCC form
           provided the change does not affect validated process ranges
           (critical process parameters) and provided the method for
           changing and challenging these are described in an SOP or
           Validation Document approved by validation. Changes to
           operating parameters not described in an SOP require a VCC
           Form to be completed.

2.1.3.2    Changes to GXP Documents
           In addition to changes described for validated
           systems/processes in this procedure, changes to GXP
           documents could potentially compromise the validation status of
           systems/processes. An assessment of changes to GXP
           documents and their impact on validated systems must be
           documented at the time of approval of GXP documents.
           It is the responsibility of departments who distribute GXP
           documents to provide to validation a copy, prior to approval, of
           planned changes to GXP documents where the type of change is
           described in Appendix 1.
           Validation will maintain a list of Standard Operating Procedures
           that require assessment by this procedure for changes. This list
           will be used by QA Documentation to identify which document
           must be reviewed according to the criteria in Appendix 1 -
Title     Validation Change Control SOP
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           “Changes Requiring a VCC Package”. If the document is on this
           list and meets the requirements of Attachment 1, then a copy of
           the GXP document indicating the proposed changes must be
           prepared and sent to validation.
           The validation staff will document the assessment of the GCP
           document planned change using a VCC form. Where the change
           will require validation, the VCC form will be completed as
           described in sections 1-3 of this SOP. If the assessment of the
           change is determined to not require validation, the only
           approval required is from validation and the VCC form is
           considered complete.

2.1.3.3    Trial Hold
           Validation must provide written notice (e.g. Exception Report or
           memo) to QA Product Release indicating the need to place drug
           product on Validation HOLD prior to the final approval of the
           VCC Package where the intended change directly affects data
           quality, patient safety, or regulatory status.

2.2        Assessment
           The Validation Assignee enters an assessment which indicates:
               1. whether the change does or does not have validation
                  impact
               2. whether product release is affected
               3. the protocols to be used
               4. any other applicable documentation required to complete
                  the change control requirements.
           Some changes may affect the validation of a computer system
           and the validation of the business process. When this occurs,
           both the validation group and QA function responsible for the
           validation of business processes must approve the assessment
           and final VCC Package. In this situation, a single VCC form
           should be prepared.
           If the change does not have impact, an explanation is required
           in the appropriate section of the VCC Form.
           The assessment portion of the VCC Form may indicate that
           testing will:
               1. not be required;
               2. require the execution of previously used protocols;
Title     Validation Change Control SOP
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               3. require the execution of new protocols/test functions to
                  be written and approved, or;
               4. include the execution of attached test functions.
           The final assessment is reviewed and approved by validation
           management. The client and developer review and approve the
           assessment indicating their agreement to proceed with the
           change. Implementation of changes must be scheduled to
           coincide with validation. The assessment review and approval
           described above are those minimally required. Additional
           approvers (e.g. lab personnel) can be added as deemed
           necessary by validation.

2.3        Cancelling a VCC Form
           After a VCC Form has been initiated and approved, it can be
           cancelled if work is not planned for completion. Cancelled VCC
           forms should be routed for approvals and filed in archives.



2.4        Completion of the VCC Package
           Once the assessment portion of the VCC Form is approved,
           validation will begin to perform the appropriate activities (DQ,
           IQ, OQ, PQ, collect updated drawings, etc.) as specified by the
           VCC Form. Validation will insure that all document updates
           required by the validation effort are completed and approved
           prior to approval of the VCC Package (redlined drawings are
           acceptable).
           Upon final approval of the VCC Package, validation will provide
           written notice to QA Product Release (e.g. Exception Report or
           memo) requesting the removal of associated commercial
           product from HOLD. Validation will also notify the client and IT
           so that the change can be implemented for production use.

2.5        Testing During Change Control
           Changes to a validated system must be evaluated to determine
           the type and extent of testing required. The Validation
           assessment of the change is recorded on the Validation Change
           Control form. Testing will include one or more of the following:
                  Unit Test Plan - A Unit Test Plan will usually be required if
                   the change affects more than one unit.
Title     Validation Change Control SOP
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                  Revised Unit Test Case(s) - A Unit Test Case should be
                   updated and executed if the module or program is
                   changed to add or delete functionality. This would occur
                   only after the appropriate changes were also made to the
                   design and/or program specification. A system test case
                   should not be updated and executed if the change does
                   not impact other units. Examples of this are as follows:
                      o   adding a column to a report from existing data
                      o   a module edits results in an incorrect error
                          message
                  System Test Plan - A System Test Plan will usually be
                   required if the change affects more than one system test
                   case.
                  Revised System Test Case(s) - A System Test Case
                   should be updated and executed if the module or program
                   is changed to add or delete functionality, which may
                   impact other units. Examples of this are as follows:
                      o   changing the format of data being transferred by
                          an interface program
                      o   changing, adding, or deleting fields in a database
                  Other Validation Protocol (Operational Qualification)
                   testing
                  Test instructions within the VCC - Testing may be
                   accomplished by instructions within the VCC instead of in
                   some combination of separate Validation Protocols, Unit
                   Test Plan, Unit Test Cases, System Test Plans, or System
                   Test Cases. This should be done when it is not important
                   to test the condition in potential future re-executions of
                   the test protocols. It is up to the person assessing the
                   VCC to determine when this is appropriate. Examples
                   when this would apply are as follows:
                  verification of text changes in reports, screens, or error
                   messages
                  verification of a data conversion program to be executed
                   once only

2.6        Document Records and Archives
           Appropriate validation personnel or designated individuals will
           key reference information from the VCC Package into the
           validation tracking system and archive the documents.
   Title          Validation Change Control SOP
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   3                    Appendix 1 – Changes requiring VCC

AREAS OF CHANGE                                                                                          VCC Form
                                                                                                         REQUIRED
Utility Equipment (Network Equipment)
   Improvements / enhancements / major overhauls                                                            Yes
   Removal from operation / use                                                                             Yes
   Relocation of qualified equipment                                                                        Yes
   Instrument Calibration Classification (defined by SOP EG602)                                             Yes
   Routine Preventive Maintenance                                                                           No
   Repair / replacement with identical parts                                                                No
   Out of calibration                                                                                       No
Computer Systems/Application Software
   Improvements / enhancements                                                                              Yes
   Modification of software source or object code for any reason                                            Yes
   Relocation or removal to/from operation of qualified equipment                                           Yes
   Modifications to a non-validated system where the new functions are GXP critical                         Yes
   Changes to calibration or tuning parameters made outside ranges established in SOPs                      Yes
   Changes to calibration or tuning parameters made outside validated operating parameters                  Yes
   (critical process parameters)
   Initiation or modification of interfaces between validated and non-validated computer systems.           Yes
   Associate the VCC with the validated system
   Changes to workstation configuration (under change control)                                              Yes
   Operating system or environment changes that impact the application                                      Yes
   Addition, modification, or deletion of data using unvalidated programs or tools                          Yes
   Replacement of the following components with components of equivalent rating to original:                No
   batteries, relays, fuses, ink cartridges, switches, connectors, cables, insulation, fans, covers,
   and power supplies
   Replacement of components or assemblies where the part number or model number (except                    No
   for revision level) is the same as the original, including floppy disc drives, magnetic or bar code
   reader or subassembly, copier or subassembly, radio frequency or microwave transmitter or
   subassembly, circuit boards, integrated circuits which are not EPROM’s, mouse, track ball,
   keyboards, motors, belts, internal optical, inductive, or capacitive sensors, or LED, LCD, CRT,
   or gas discharge displays
   Adjustments to convergence, contrast, or brightness of CRT’s, or contrast, registration, or              No
   forms thickness on printers
   Cleaning or reseating of components or connectors                                                        No
   Adjustments to power supply                                                                              No
   Title           Validation Change Control SOP
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   Attachment of programmable diagnostic devices for troubleshooting                                    No
   Changes to system calendars or time of day clocks                                                    No
   Removal and application of power                                                                     No
   Unplugging the system from the electrical power grid or network                                      No
   Out of calibration (printers)                                                                        No
   Computer Programming Device Connections to Validated Systems when the device is only                 No
   used to monitor the controller’s activity and no program changes are made. Examples:
   troubleshooting inputs/outputs, checking scan times, viewing data file values
Standard Operating Procedures
   SOPs identified by CCV (generally these are describing critical process parameters, such as          Yes
   cleaning, equipment operation/use, sterilization, etc., where these parameters are not defined
   in batch records.
   Removal from operation / use                                                                         Yes
   Typing/Grammatical errors                                                                            No
   Format changes to the procedure                                                                      No