Appendices To The Guidelines For Validation & Qualification, Including .
Appendices to the Guidelines for Validation & Qualification, including ChangeControl, for Hospital Transfusion LaboratoriesThis document contains the appendices to the BCSH guidelines on validation andqualification which is available to download from www.bcshguidelines.comBritish Committee for Standards in HaematologyAddress for correspondence:BCSH SecretaryBritish Society for Haematology100 White Lion StreetLondon N1 9PFe-mail bcsh@b-s-h.org.ukWriting group:S. Allard1, G Burgess2, B. Cuthbertson3, C Elliott 4, R Haggas5, J Jones6, BRobertson7, D Sadani 8 K Smith2DisclaimerWhile the advice and information in these guidelines is believed to be true andaccurate at the time of going to press, neither the authors, the British Society forHaematology nor the publishers accept any legal responsibility for the content ofthese guidelines.Date for guideline reviewJuly 20141, Barts and the London NHS Trust & NHSBT, Royal London Hospital, 80 Newark StreetLondon E1 2ES2NHSBT, Long Road, Cambridge, CB2 2PT3SNBTS, Ellens Glen Rd, Edinburgh4James Cook University Hospital, Middlesborough5Blood Transfusion Dept, Leeds General Infirmary, Great George Street, Leeds. LS1 3EX6WBS, Ely Valley Rd, Cardiff CF72 9WB7Guys & St. Thomas‟ Hospital NHS Trust, Westminster Bridge Road, London SE1 7EH8Leeds Blood Centre, Bridle Path, Leeds
Contents1. Information to be included in the Validation Master Planpage 032. Example of a VMP currently in use in an NHS Hospitalpage 073. Change Control Request Formpage 114. Specifications of what could be included in a UserRequirement Specificationpage 145. Example of a User Requirement Specificationpage 176. Specifications for inclusion in FDSpage 237. Example of a Validation Planpage 258. Installation Qualification, Operational Qualificationand Process Qualificationpage 309. Example of Validation Protocolpage 3310. Example of a qualification Proformapage 3511. Validation sign off reportpage 5012. Acknowledgements and Declarations of interestpage 51
Appendix 1Table 1. Information to be Included in the Validation Master Plan (VMP)Section:OrganisationalStructure andResponsibilitiesGuidance: Validation requires a structured approach. Large organisations mayhave a validation department however, each laboratory should atleast appoint one or more of its managers/senior scientists to act asa validation manager(s) responsible for producing the validationplan which will include a validation protocol and selecting andsupervising a validation team to perform and record the validation. There are three distinct functions to be performed;- planning the validation- performing the validation- approving the validation Planning will require expert input from scientists, engineers,clinicians, Quality Assurance and suppliers of equipment andmaterials in order to devise appropriate and effective validationprotocols (See section 11.2). Staff performing validation work should be experienced operatorsand will need supervision to ensure that the validation protocol isproperly followed and the outcome accurately recorded. Approval that the process or system is valid and fit for purpose isneeded at the end of the process and this should be a role for anindependent expert, i.e. laboratory QA Manager. All roles and responsibilities should be formally documented in thissection.Summary of whatshould bevalidated.Typically in a transfusion laboratory the following areas will be subject tovalidation - new / established critical process, equipment, facilities orsystems. Sample/Blood Component reception/booking-in.Sample transfer and storage.Sample handling (Particularly robotic dispensing systems)Controlled temperature storage of critical reagents and controls.Test methods.Result reporting and blood component labelling & tracking.Blood Component storage.Blood Component Distribution.The performance of these process, equipment, facilities or systems willdepend on the quality of critical inputs, or components that, if they fail tofunction correctly, could adversely affect the quality of samples, testresults or blood components. Critical inputs or components are: EquipmentFacilities and utilitiesTest kits & reagentsAutomation and IT hardware & software.As a minimum, these inputs or components need to be qualified (Seedefinitions) to ensure that the processes and systems are valid and fitfor purpose. It is useful to identify the key inputs or components to besubject to qualification as part of validation in this section.Appendix 1: Information to be included in the validation master plan3
For the laboratory computer system critical inputs will include hardware,operating system and application software.Planning.The amount of validation for computerised systems will depend oncomplexity and amount of customisation. Guidance on this can be foundin the Good Automated Manufacturing Practice (GAMP)5 guidelinesThe output from planning is a validation protocol (See section11.2).This section of the VMP should describe or refer to the procedures forplanning, producing and approving the validation protocol. It may alsodescribe the selection and activities of the validation team.The protocol should: Describe the risks and rationale for the particular qualification orvalidation. Define the expected outcome(s) from validation tests. Describe or refer to the validation or qualification procedures to beused.In planning the scope, extent and methods for validation, the followingshould be considered: The quality risk associated with failure of the process and system(See section 8). The need to meet technical quality specifications and regulatoryrequirements.Scheduling.Effective qualification or validation relies on having a good definition ofrequirements (See Section 9) as the acceptance criteria provided in theprotocol should be based on meeting these.This section of the VMP should describe how the validation teamundertake performing and recording the validation work and how thevalidation is signed-off and deemed acceptable.The typical phases of a validation schedule are: Training in the protocol and new operational techniques. This will berequired before members of the team are competent to carry out thevalidation particularly if a new, unfamiliar piece of equipment isbeing used. Performing validation. Validation results should be recorded at thetime and presented in a validation report (See Section 11.3) forcomparison with the acceptance criteria in the protocol. It iscommon to summarise the validation method and provide theacceptance criteria in validation scripts and the validation teamsimply records whether the required outcomes are achieved (Seeexamples Appendix 10). Validation Final Summary Report review and sign off (section 12.3)Following validation, the validation team should present thevalidation report for review and sign-off. The report should at leastbe reviewed and signed-off as an accurate record by the ValidationManager (See above).Decision. Finally, a decision is required by the independent expert (Seeabove) as to whether the process, equipment, facilities or systems.under validation is acceptable.Appendix 1: Information to be included in the validation master plan4
Normally if any of the acceptance criteria are not met, then the processis rejected.It is possible to accept a process or system where validation outcomesare not as expected, or are borderline or ambiguous This would be a„Qualified Acceptance‟ and may be acceptable if: On the basis of further analysis and quality risk assessment it isdeemed safe to accept. A comment is recorded giving the rationale for the decision.Certain additional constraints or conditions are applied to the process,equipment, facilities or systems and these are stipulated and recorded.ValidationDocumentation. Validation, changecontrol & projectmanagement. Links to otherQuality SystemProcesses.Procurement:Template consistency In order to ensure a consistent “House Style”and, more importantly, that all requirements are met, the format forthe Validation Protocol and for Validation Records/Reports shouldbe specified in a controlled manner as an integral part of the QualityManagement System.This section should describe these or refer to the relevant qualitysystem documents. It is common practice to produce validationrecords as scripts (See Appendix 10) using a controlled pro-forma.The purpose of Change Control (See Section 7) is to maintain thevalid state of critical laboratory process, equipment, facilities orsystems as changes are proposed and implemented.This section of the VMP can be used to either describe the changecontrol process or to refer to separate change control procedureswithin the quality system.It should show how validation process fits into the overall changecontrol process.The implementation of entirely new laboratory process, equipment,facilities or systems may be managed through change control, butthese, and possibly more extensive changes, may be large inscope, involving significant business risks. It may therefore benecessary to use formal project management arrangementsavailable to, or imposed upon the laboratory.This section should make it clear how any formal projectmanagement arrangements ensure that the validation requirementsare identified and met. The project management methodologyshould require individual VMPs to be produced (See Above).These links may be shown diagrammatically.Validation is usually focussed on validating operational processes andsystems and qualifying the facilities, equipment and materials used inthe process or by the system. Clearly the facilities, equipment andmaterials are usually supplied by third parties.Therefore: The laboratory quality system should control the procurement andsupply of quality critical goods and services. This should include the qualification of suppliers and possibly trialsor evaluation of equipment or materials prior to purchase.Appendix 1: Information to be included in the validation master plan5
Training &Document Control:It is also possible that an important part of the qualification of newfacilities, equipment etc. known as Design Qualification and willrelate to the Functional Design Specification (See Section 10), isperformed as part of the procurement process.Clearly, the outcomes from this activity will influence subsequentvalidation before these goods and services are put into use andtherefore, this section of the VMP should describe, or refer to, thesupplier control procedures.Development of SOPs and training in the use of these SOPs foroperating any new system will be crucial before it is finally approved foruse. This requirement will normally be included in the PQ protocol.Once the laboratory process, equipment, facilities or systems has beenapproved for use, it is essential that documentation is maintained in acurrent state. Therefore, part of maintaining processes and systems in avalid state is the qualification of operational staff and of SOPs used.As these are usually described in separate training and documentcontrol procedures they should simply be referenced in this section.Facilities &Equipmentmanagement:It would be appropriate to describe or reference any staff proficiencyschemes operated by the laboratory in this section.The management and control of facilities and equipment is critical tomaintaining the valid state. In particular servicing, calibration ofinstrumentation and re-qualification should be planned and managedwithin the laboratory quality system.These arrangements may be described in this section or referencemade to the appropriate procedures.Automated test systems may be subject to proficiency or EQA Schemesand these should be mentioned here.Appendix 1: Information to be included in the validation master plan6
Appendix 2Example of a VMP currently in use at an NHS HospitalDepartment of Blood TransfusionCode: enter detailsPage Insert numbersTitle: Validation Master Plan (VMP)Area of application:Blood Transfusion Hospital ABlood Transfusion Hospital BBlood Transfusion Hospital CIndex code:Implementation date:This copy issued to:Related CPA standard/key words:This document is under the department document control system.To comply with CPA standard A8 the document control system records the reason for change, current revisionstatus of documents, dates of review, document owner and approver and locations of printed copies.It is forbidden to photocopy from authorised printed copies which have been issued to locations as recorded in thesoftware. Authorised printed copies can be identified by the authorisation signature and stamp present in the spacebelow.SIGNATURELIST OF CONTENTSPage NoSection1.2.3.4.5.6.7.2234455Validation PolicyOrganisational structure of validation activitiesSummary of the facilities, systems, equipment and processes to be validatedDocumentation formatPlanning and schedulingChange controlReferencesAppendix 2: Example of a VMP currently at use in an NHS hospital7
1.Validation Policy1.1The validation policy of the Insert name Hospitals blood Transfusion Department is set out inthe policy document insert number/link. This policy applies when a change is proposed to astarting material, product component, process equipment, process environment (or site),method of production or testing or any other change that may affect product quality (or resultquality) or reproducibility of the process2Organisational structure of validation activities2.1Planning validation2.1.12.1.42.1.5All validation planning is the responsibility of the Blood Transfusion Quality Manager wholiaises with the appropriate Site Coordinator or his designated deputy to ensure thatappropriate validation takes place.The validation planning should also involve experts in the area being validated. Major IT validation should involve the IT coordinator Validation in Ante-Natal Testing should involve the Ante-Natal coordinatorFor each validation there will be a validation team comprising; The Quality Manager A Site Coordinator or designated deputy Other experts as appropriateThe quality Manager will be responsible for assembling the validation teamFor large scale changes there may need to be separate validation plans covering each area2.2Performing 233.1.1All validations should be performed by staff familiar with the processes being validated. Thelaboratory validations must be performed by a Health Professions Council RegisteredBiomedical Scientist or above and overseen by an Advanced Biomedical Scientist or aboveApproving validationNormally all validations will be approved by the Quality ManagerOccasionally validations may be approved Department Manager or appropriate SiteCoordinator in the absence of the Quality ManagerFinal validation summary reportThere should be a document to indicate whether approval for release has beengiven, this should include any conditions on release.Final sign off of the validation must be by the Department Manager, Quality Manager orappropriate Site-CoordinatorSummary of the laboratory process, equipment, facilities or systems to be validatedAny changes to the systems or processes in the following areas need to be validated Sample labelling reception and booking-in Sample storage and transport. Automated Sample handling systemso Insert machines Controlled temperature storage of critical reagents and controls. Critical Test methods including result reporting.o Electronic issueo Crossmatchingo Grouping and antibody screeningo Phenotypingo DAT testingAppendix 2: Example of a VMP currently at use in an NHS hospital8
o Antibody investigationo Transfusion Reaction investigationo MAJAX procedureso Ante-natal Testing Blood component processing labelling & tracking.o Secondary processing systems Plasma thawers Platelet agitatorso Labelling procedureso Release procedures Blood Component cold storage.o Receipt procedureso Storage procedureso Monitoringo Alarms Blood Component Distribution.o Blood Track procedureso Traceability procedures4Documentation format4.1All validation documentation should take the same format this will be:4.2Validation .2.104.2.11Approval sheetDocument change control sheetPurpose and scopeBackground ReferencesDefinitions and acronymsSystem definition and descriptionSystem maintenance and support strategyValidation approachImplementation strategyTraining requirements related to responsibilitiesAppendices4.3Validation summary report (see template in Appendix 11)4.3.1Introduction; to include Validation plan detailsValidation resultsUnexpected results / problemsRecommendations / Further actionContinuing ValidationReferences; to include Validation master plan Validation Plan Change control4.3.24.3.34.3.44.3.54.3.65Planning and scheduling5.15.2All validations should be plannedThe validation plan should incorporate any planning and a timescale for implementation. Thedecisions on timescale will be down to the validation team.6Change controlAppendix 2: Example of a VMP currently at use in an NHS hospital9
6.16.26.2.16.2.26.2.36.2.46.3For any proposed change to anything which could affect the quality or reproducibility of testresults or components is completed.Change control is needed for changes to:Starting material (e.g. reagents, consumables)Procedure / methodEnvironmentEquipment6.3.16.3.26.3.3Changes are assessed by the Quality Manager and any other appropriate officers. The result ofthis assessment can be either:Change approved no validation neededChange approved validation requiredChange not s7.4Add templatesAppendix 2: Example of a VMP currently at use in an NHS hospital10
Appendix 3CHANGE CONTROL REQUEST FORM11.1Title of ChangeChange to new panel cell supplier2Reason for Change2.1Investigation of a failure to identify a combination of antibodies in a NEQAS exercise suggested that one of thecontributory factors in this identification was the poor antigen profile of the panel cells currently used2.2Examples of supplier B panel cell antigen profiles were sought and these would have produced unequivocal results andwould have aided identification2.3The department would like to source its antibody identification panels from supplier B3Description of Change3.1Change of panel cell supplier from Supplier A to supplier B3.2Cells from supplier B will be provided in modified Alsevers solution at 3%. In order to use these cells by the currenttechnique the cells will need to be washed and prepared to 0.8% in supplier A’s diluent.3.3The diluent product insert indicates a method for preparing cells to 0.8%. The insert indicates that fresh cells (from patient’sor donor blood) prepared in this manner will remain stable for 7 days. The insert indicated that commercial panel cellsprepared in this manner are only guaranteed to be stable for 24 hours. Cells used in this manner do not need any validation3.4Daily preparation and use is not practical within the department. The department would like to demonstrate that supplier B’scells can be prepared using the method on the diluent product insert and remain suitable for use for 7 days or longer.Appendix 3: Change control request form11
4Impact//Quality Risk Assessment4.1Risk matrix used in assessment: Risk score Impact x n12InsignificantLow54Almost tastrophic1RareRiskScoreRisk Level - Treatment TimeframeScoreRisk Rating1-3LowTheserisksareconsideredacceptable, no action over and aboveexisting procedures4-6ModerateMonitoring of risks with view toeffort being made to reduce thesewithin a 12 month period8-12SignificantManagement consideration of risksand reduction of these within 6 mmediately with view to actionbeing taken to reduce riskAntibody Identification has a number of potential risks associated with it4.2.1Failure to detect clinically significant antibody can result from An inadequately prepared panelo Incorrect cell suspensionso Incorrect tubing out of panel cellso Failure to add patient’s plasma Deterioration of red cell antigens through storage Failure to provide all relevant clinically significant antigens on the profile particularly those with homozygousexpression4.2.2Failure to identify antibody can result from Deterioration of red cell antigens through storageAppendix 3: Change control request form12
Failure to provide all relevant clinically significant antigens on the profile particularly those with homozygousexpression Antigen profiles on panels providing insufficient antigen negative cells making distinguishing of antibody mixturesparticularly difficult4.2.3All of the above risks can cause potential serious problems to patients including: Failure to provide compatible blood Risk score 4x3 12 Failure to provide compatible blood in a timely fashion – caused by additional testing or need to refer samples wherethe panels cannot provide antibody identification Risk score 4x3 125Mitigation of risks5.1Incorrect Cell Suspensions: can be mitigated by the production of a robust standard operating procedure which ensuresthat the cell suspensions are prepared by the same method as indicated on the diluent product insert.5.2Incorrect tubing out of cells: can be mitigated by the production of a robust standard operating procedure which ensuresthat cells are prepared and labelled in the same way each time5.3Failure to provide an inadequate antigen profile: this is mitigated by ensuring that the cells meet the Red BookGuidelines5.4Deterioration of red cell antigens on storage: This can be mitigated by validation of the activity of a prepared panel fromdate of preparation (as soon after receipt as possible) until its expiry.5.5Activity of Panel cells: The panel cells should be quality controlled after preparation to demonstrated that they are workingcorrectly6Validation requirements6.1A validation plan must be prepared and validation performed to demonstrate that supplier B’s panel cells do not deteriorateAppendix 3: Change control request form13
when prepared in diluent and subsequently stored. The validation should involve the use of CE marked weak antisera (antiD, anti-c and anti-Fya).7Documentation7.1The following documentation will be needed7.1.1A validation plan / protocol7.1.2Validation results sheets7.1.3A validation report7.1.4A validation sign off report7.2The following documents will need checking / updating7.2.1BBSOP Preparation and QC of panel cells [BBSOP0174] – this is the SOP the validation will be performed against8ReferencesChange ApprovalYES/NO (delete as teDateDateSignatureSignatureSignatureAppendix 3: Change control request form14
Appendix 4Specifications of what could be included in a User Requirement l requirementsSystem functionsData handling requirementsSystem interfacesEnvironmentDetails to include Who produced the document, their authority and forwhat purpose. The contractual status of the document. Relationship to other documents Background (departmental strategy, previous studiesetc.) Key objectives and benefits Main functions and interfaces Applicable GxP requirements (e.g. CE mark, BSQR, BSstandards) Other applicable regulations and guidelines (BCSHguidelines) Functions required, including information on theprocess or existing systems (e.g. perform red cell groupand antibody screen). Calculations, including all critical algorithms (interprettest results to correctly identify a blood group) Modes of operation (e.g. start-up, shutdown, test,backup) Quantitative and unambiguous performance and timingrequirements (e.g. turn around times for routine orurgent samples, QC etc.) Back up in case of system failure (e.g. engineerresponse time) Safety Security Maintenance (e.g. planned preventative, calibrationetc.) Definition of data including critical parameters, validdata ranges and limits. Capacity requirements (e.g. disk storage capacity,archive capacity etc.) Access speed requirements (network speed, responsetimes) Data security and integrity Define staff groups in terms of roles or functions (e.g.Biomedical Scientist, Biomedical Support Worker,porter). Interface with other systems (e.g. LIMS) Interface with equipment (e.g. blood issue fridges,blood group analysers) Physical layout of the working environment.Appendix 4: specifications of what could be included in a User RequirementSpecification15
Physical conditions (e.g. dusty, sterile, air conditioned)Constraints Timescales and milestones (e.g. speed of delivery,commissioning time etc.) Compatibility (e.g. will the software work on yourcurrent server / IT system) Availability (e.g. required 24/7 or 23 hrs per day) Procedural constraints, these include external but interrelated factors (e.g. specimen tube type, workforce skillmix) CostGlossary Definitions of any terms that may be unfamiliar to thereaders of the document.Appendix 4: specifications of what could be included in a User RequirementSpecification16
Appendix 5Example of a User Requirement SpecificationProvision of Blood Grouping analysers and reagentsThe proposed equipment must be able to meet the current workloads with capacity to increasethese by xx%.The current annual blood transfusion workload is approximately Blood Groups and screens: enter number DAGT: enter number Neonatal grouping with DAGT: enter number Antibody panel‟s approx: enter number Full crossmatch on cards: enter numberProposals are required for processing of the current workload as stated. The requirementmust address but not be limited to: Delivery, Installation Commissioning Consumables Reagents Quality Control Maintenance of the equipment Bi-directional interface to the laboratory computer system (Enter system) Training Disposal of equipment at the end of the life.The Tenderer must detail how they will comply with the requirement. 2.It is a requirement that the current laboratory output must be maintained during installation,acceptance testing and qualification of the automation.Proposals must be able to show from current users a high level of satisfaction regarding theautomation, product and technical support and customer care.The supplier and their automated users must have a proven track record with regards toNEQAS returns.The supplier must have adequate support facilities.General Analyser Specification Proposals must specify the proposed equipment, hardware, uninterruptible power supplyetc.All equipment proposed must be automated, and capable of meeting the volumes provide inthis document with the ability to increase by at least xx%.Due to the nature of the work the User requires equipment to be operable 24 hours a dayseven days a week. Currently the User has four analysers installed to manage anyinoperable time, and must state how they will ensure equipment will be operable 24/7.Details of guaranteed uptime (and its definition) must be provided, details on; how uptime ismeasured, how this will be attained, and remedies to the Authority if the uptime is notmaintained are required to be submitted.Guaranteed uptime must be 24 hours a day seven days a week provided over a calendarmonth, tenderer’s must provide details of how this will be achieved.(Mixed field reaction for post BMT relapses and mixed ABO transfusion should berecognised).Appendix 5: Example of a user requirement specification17
The range of tests that must be available on the machine are (but not limited to) the following; ABO and Rh D grouping both full ABO group3 cell antibody screens by IATDAT‟s including monospecific typingAntibody identification panel with enzyme treated and IAT cellsSecondary antibody identification panel with enzyme treated and IAT cellsMiscellaneous red cell phenotypingThe analyser must be capable of running without continual operator presence.The proposed system must allow customer definable password protection levels and users.User friendly and safe operation is expected. Start up, shut down, calibration, QC, localmaintenance and general cleaning procedures must be stated and the length of timeinvolved and required frequency of these procedures. Requirements and consumption ratesfor power, water, saline, drainage and air conditioning must be stated and installation costsincluded.Details of any additional consumables, special waste containers must be provided and fullcosts provided.Proposed system must conform to current blood transfusion guidelines as defined by theBritish Committee for Standards in Haematology (BCSH) – Blood Transfusion Task Forceor equivalent.Proposed system must conform to current EC directives for in vitro diagnostics (IVD)electrical safety (CE) and CPA guidelines or equivalent.The tendered should state whether they have a software package to assist in theidentification of atypical antibodies and whether this attracts an additional cost.Fully detailed operator manual must be provided. Such manuals must be renewed as andwhen the instrument software or hardware is updated and must be supplied in English.The User will expect all safety upgrades or enhancements to the equipment to beundertaken free of charge.3.InterfacingProposed equipment must be compatible with the laboratory‟s LIMS (currently insertsystem). Tenderers should state how many installations of the proposed system areinterfaced with this LIMS, giving location and contact information for each.Interfaces must be operable before “go live” and noted in a project plan or key stagedocument with the submission, Tenderer‟s must also advise of any remedies if theproposed project plan is delayed.Tenderer‟s must state details of any Laboratory information systems the proposed system isinterfaced with, providing relevant c
8. Installation Qualification, Operational Qualification and Process Qualification page 30 9. Example of Validation Protocol page 33 10. Example of a qualification Proforma page 35 11. Validation sign off report page 50 12. Acknowledgements and Declarations of interest page 51
May 02, 2018 · D. Program Evaluation ͟The organization has provided a description of the framework for how each program will be evaluated. The framework should include all the elements below: ͟The evaluation methods are cost-effective for the organization ͟Quantitative and qualitative data is being collected (at Basics tier, data collection must have begun)
Silat is a combative art of self-defense and survival rooted from Matay archipelago. It was traced at thé early of Langkasuka Kingdom (2nd century CE) till thé reign of Melaka (Malaysia) Sultanate era (13th century). Silat has now evolved to become part of social culture and tradition with thé appearance of a fine physical and spiritual .
On an exceptional basis, Member States may request UNESCO to provide thé candidates with access to thé platform so they can complète thé form by themselves. Thèse requests must be addressed to esd rize unesco. or by 15 A ril 2021 UNESCO will provide thé nomineewith accessto thé platform via their émail address.
̶The leading indicator of employee engagement is based on the quality of the relationship between employee and supervisor Empower your managers! ̶Help them understand the impact on the organization ̶Share important changes, plan options, tasks, and deadlines ̶Provide key messages and talking points ̶Prepare them to answer employee questions
Dr. Sunita Bharatwal** Dr. Pawan Garga*** Abstract Customer satisfaction is derived from thè functionalities and values, a product or Service can provide. The current study aims to segregate thè dimensions of ordine Service quality and gather insights on its impact on web shopping. The trends of purchases have
Bruksanvisning för bilstereo . Bruksanvisning for bilstereo . Instrukcja obsługi samochodowego odtwarzacza stereo . Operating Instructions for Car Stereo . 610-104 . SV . Bruksanvisning i original
Chính Văn.- Còn đức Thế tôn thì tuệ giác cực kỳ trong sạch 8: hiện hành bất nhị 9, đạt đến vô tướng 10, đứng vào chỗ đứng của các đức Thế tôn 11, thể hiện tính bình đẳng của các Ngài, đến chỗ không còn chướng ngại 12, giáo pháp không thể khuynh đảo, tâm thức không bị cản trở, cái được
10 tips och tricks för att lyckas med ert sap-projekt 20 SAPSANYTT 2/2015 De flesta projektledare känner säkert till Cobb’s paradox. Martin Cobb verkade som CIO för sekretariatet för Treasury Board of Canada 1995 då han ställde frågan
