Date: 07 June 2013 Version: 4 Page 1 of 10

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1 Date: 07 June 2013 Versin: 4 Page 1 f 10 STANDARD OPERATING PROCEDURE FOR THE DEVELOPMENT AND VALIDATION OF TRIAL DATABASES AND RELATED SOFTWARE (NWORTH 6.02) Apprvals Principal Authr Name: D. Skelhrn Signature: D. Skelhrn Date: 07/06/2013 Quality Assurance Officer Name: p.p. T.H. Rberts Signature: T.H. Rberts Date: 09/06/2013 NWORTH Directr Name: R.T. Wds Signature: R.T. Wds Date: 10/06/2013 Disclaimer: Printed SOP's are cnsidered uncntrlled. T ensure yu are wrking with current versin always refer t the pdf versin n the NWORTH website Nrth Wales Organisatin fr Randmised Trials in Health (& Scial Care) (NWORTH) Institute f Medical & Scial Care Research (IMSCaR) Y Wern, Hlyhead Rad, Bangr University, Bangr, Gwynedd, LL57 2PZ Telephne: nwrth@bangr.ac.uk

2 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 2 f 10 DOCUMENT HISTORY Versin number Effective date Authrship 1 9/09/08 (cmpiled) M. Lin Rh. Whitaker 2 14/10/09 P. McDnald K. Mawdesely 3 12/01/12 D. Skelhrn D.S. Hunnisett 4 12/06/13 D. Skelhrn D.S. Hunnisett Summary f changes New SOP numbering (16 t 6.02) and layut amended. Cmplete re-write. Cmplete re-write Minr changes t sectin 5.4 qualificatin prtcls and sectin 5.10 t clarify when change cntrl is applied 1. Table f Cntents 1. Table f Cntents Purpse Scpe Respnsibilities Prcedure Flw Chart Validatin Plicy Validatin Apprach Validatin Strategy Develpment and Design Phase Design Qualificatin Installatin Qualificatin (IQ) Operatinal Qualificatin (OQ) Perfrmance Qualificatin (PQ) Changes requested pst validatin Validatin Maintenance Training plan fr SOP implementatin Glssary f Terms References Referenced SOPs Appendices... 9 Appendix 1 Assessing level f validatin NWORTH: Telephne: nwrth@bangr.ac.uk

3 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 3 f Purpse This SOP is t describe the plicy fr design, develpment and validatin f IT sftware and underlying databases within NWORTH that are used t manage and stre trial data. It is based arund agile sftware develpment prcesses within the validatin prcess. Cmputer validatin is defined as thse activities necessary t establish dcumented evidence prviding a high degree f assurance that a system will cnsistently meet its predetermined specificatins and quality attributes, and will cntinue t d s. 3. Scpe This prcedure applies t trial sftware and trial databases develped r amended by NWORTH. Currently this encmpasses 3 main types f system: 1. Systems that capture data nline and stre data n NHS r University servers 2. Systems develped using third-party applicatins such as MACRO 3. Standalne sftware systems Hwever, the general principles can be applied t any future sftware develpment undertaken by NWORTH. The detail f hw t cnduct the qualificatin phases will be described in wrk instructins. 4. Respnsibilities Validatin is generally a multi-disciplinary activity requiring active participatin f ther grups End User(s): are the peple / persn, wh will be using the trial data systems t manage and stre trial data. The develpment must ensure that their requirements are thrughly and apprpriately addressed. All r any f the fllwing rles (eg. Trial Manager, Statistician, NWORTH Trial unit Manager) may be an end user. The end users must nminate at least ne user representative. IT Specialist is respnsible fr the analysis, design, develpment, testing and implementatin f the trial data systems. A secnd independent specialist shuld review the cde. System Hst is respnsible fr : hsting and supprting the technical infrastructure n which the trial data systems will run, in the case f systems hsted and run within NWORTH, Bangr University Central IT will act as the System Hst, Trial Manager is respnsible fr: The implementatin f trial data systems t supprt trial administratin. Where required, prvide sign-ff at specified pints in the systems develpment prcess. Statisticians and ther trial investigatrs are respnsible fr : Where required, t prvide sign-ff at specified pints in the systems develpment prcess. Trial Unit Manager is respnsible apprving the validatin master plan and the validatin summary reprt. NWORTH: Telephne: nwrth@bangr.ac.uk

4 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 4 f 10 Quality Assurance fficer is respnsible: fr cmpiling the validatin master plan, apprving the qualificatin dcumentatin (such as prtcls and summary reprts). 5. Prcedure 5.1 Flw Chart User Requirement Specificatin Design Phase Functinal & Design Specificatins (if required) System develpment ( Agile apprach) Validatin Master Plan DQ/IQ/OQ/PQ PROTOCOL DEVELOPMENT Further generatin r upgrading f SOPs, Supprt Prgrammes On-ging training PROTOCOL EXECUTION Remedial Wrk & Retesting Acquire and lg all hand / electrnic test results PROTOCOL FINAL APPROVAL Deviatins Change Cntrl VALIDATION SUMMARY REPORT NWORTH: Telephne: nwrth@bangr.ac.uk

5 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 5 f Validatin Plicy The validatin f cmputer systems shall be achieved by means f a validatin prcess, dcumented in assciated qualificatin prtcls. The validatin is t prvide dcumented evidence that the system functins as intended and that the data cntained n its electrnic recrds have been qualified and verified t be accurate. Validatin activities will be carried ut as part f the cmplete life cycle f the system with the accepted rules and principles f gd practice t meet the applicable regulatry requirements. Validatin activities shall be planned in a lifecycle framewrk, including: Analysing requirements Design Qualificatin prtcls (including test specificatin) Prgramming Reviewing and Testing Security Operatin Change cntrl At all stages, persnnel will be apprpriately trained in their use f the system and where apprpriate in the principles f cmputerised system validatin. All activities will be dcumented t prvide cnfirmatry prf that the system qualifies and perates in accrdance with the validatin plans and apprpriate validatin prtcls. Frmal validatin plans shall be prduced defining the activities required t ensure the fitness fr purpse f GCP significant systems. Validatin reprts shall be prduced t dcument these activities. Fr existing systems, the same lifecycle framewrk shall be applied. Retrspective validatin shall be perfrmed t ensure current and cntinued fitness fr use f systems installed r implemented prir t adptin f this plicy. This apprach uses histrical data and perating histry data, t demnstrate prcess validatin, where gaps in the infrmatin available are fund additinal qualificatin may need t be carried ut. The reasning supprting decisins regarding validatin f legacy systems shuld be dcumented. The maintainability f the systems and their histry f peratin will be cnsidered. Validatin is regarded as an nging prcess that cntinues fr the lifetime f a system. A planned and systematic prgramme f peridic review and errr lgging shall be carried ut t ensure that a system remains in a validated state. 5.3 Validatin Apprach The accepted apprach t validatin is Prspective Validatin. There are hwever, sme circumstances when Retrspective Validatin is an acceptable practice. N matter what the ptin, the requirements f validatin apply e.g:- A validatin prtcl must be written. Acceptance criteria must be established. Summary Reprt must be written at the end f the validatin phase. NWORTH: Telephne: nwrth@bangr.ac.uk

6 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 6 f 10 The extent f validatin required will depend n the use t which the system is put; a risk assessment apprach may be used t help evaluate the level f validatin required. The categrisatin system in appendix 1, may be used as an aid t this evaluatin. During this evaluatin it will be determined if functinal and design specificatins are required and if any f the qualificatin phases will be cmbined. Prspective System Validatin is cnducted prir t the system being handed ver t the end user fr use in the trial. 5.4 Validatin Strategy Validatin studies must ensure that a specific system is capable f perfrming in a reliable and cnsistent manner that cnsistently meets predetermined criteria. Basis fr the validatin strategy include, but are nt limited t the fllwing:- User Requirement Specificatin (URS) The User Requirement Specificatin defines the functinal requirements f the system. It is defined by the User f the system with input frm ther functins (e.g. IT, Statistician Quality Assurance, Data Managers). Functinal specificatin The Functinal Specificatin (FS) is a dcument which is apprved by bth prvider f the system and user. It shuld be written by the persn prviding the system and describe the functins f the system. The FS shuld be linked t Operatinal Qualificatin, which tests all the functins specified. Design Specificatins (DS) The design specificatin is a cmplete definitin f the system in sufficient detail t enable it t be built. Design specificatins are develped by the prvider f the system. Fr cmplex installatins the design specificatin may cnsist f separate specificatins fr the varius parts f the system, including but nt limited t: Hardware Design Specificatin: A descriptin f the hardware n which the sftware resides and hw it is t be cnnected t any existing system r plant equipment. Sftware Design Specificatin: A descriptin f the sftware cmpnents and sub-systems. The specificatin shuld cntain enugh infrmatin t enable cding f the system t prceed. Sftware Mdule Design Specificatins: If there is mre than ne mdule, each mdule in the Sftware Design Specificatin shuld have a Sftware Mdule Design Specificatin. Netwrk Design Specificatin: This is necessary nly if the hardware elements are cnnected t a Lcal r Wide Area Netwrk. It is a descriptin f the physical cmpnents, the transprt prtcl, the NWORTH: Telephne: nwrth@bangr.ac.uk

7 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 7 f 10 netwrk perating system and any links t the hardware and ther netwrks. Design Qualificatin (DQ) The DQ is cmpiled t demnstrate (usually by means f test scripts), that the requirements described in the user requirement specificatin have been fulfilled Validatin Master Plan (VMP) The VMP is the dcument, which describes all activities required t achieve the full validatin f the system. It prvides an verview f the scpe, the reasns fr the validatin and a definitin f rles and respnsibilities. The VMP is the rad map thrugh the validatin prgramme. It addresses regulatry cmpliance. The Plan may be peridically updated, but changes must be supprted with Change Cntrl dcumentatin where necessary. The Validatin Master Plan shuld cnsider, and include where apprpriate the fllwing tpics:- Prtcl apprval. Intrductin Objective Scpe Respnsibilities Apprach Descriptin f the system Acceptance Criteria Time Lines Supprt Prgrammes Dcumentatin Qualificatin Prtcls All validatin studies must be cnducted accrding t apprved prtcls. The qualificatin prtcl must cntain the details f the specific testing and dcumentatin required fr each phase f the validatin fr the system. The prtcls shuld be written, authrised and issued befre qualificatin testing starts. Qualificatins shuld be cnducted and cmpleted in turn i.e. DQ must be satisfactrily cmpleted befre cmmencing the IQ testing. Where changes arise during the design and installatin phases they will be dcumented in the relevant qualificatin dcuments. Qualificatin prtcls shuld generally be written fr the fllwing activities (sme f which maybe cmbined):- Design Qualificatin. Installatin Qualificatin. Operatinal Qualificatin. Perfrmance Qualificatin. Validatin Summary Reprt NWORTH: Telephne: nwrth@bangr.ac.uk

8 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 8 f 10 The Validatin Summary Reprt prvides a summary f all key elements f the individual items f the validatin exercise; it dcuments a review f the DQ, IQ, OQ and PQ phase activities. This is a key dcument fr regulatry inspectins. Amendments t Prtcls Prtcl amendments must fllw the same apprval prcess as the riginal prtcl frm which they are generated. Cnclusins against the prgramme bjectives defined in the Validatin Master Plan shuld be dcumented and a frmal statement n the impact t the validatin prgramme shuld be included. Crrective actins during validatin The qualificatin prtcls will specify hw errrs r deviatins are dcumented and the actin t be taken. 5.5 Develpment and Design Phase (URS,FD, DS, Iterative develpment phase, DQ) NWORTHS apprach t sftware develpment is t utilise Agile develpment methdlgies. Agile develpment is an umbrella term fr a number f iterative and incremental sftware develpment methdlgies. 5.6 Design Qualificatin Once the develpment system has been established the Design Qualificatin is cnducted t prvide dcumented verificatin that the system has been designed in line with the user requirements and demnstrates that the requirements f GCP have been cnsidered when designing the system. 5.7 Installatin Qualificatin (IQ) The Installatin Qualificatin prvides dcumented verificatin that the system installed r mdified cmplies with user requirements. 5.8 Operatinal Qualificatin (OQ) The Operatinal Qualificatin prvides dcumented verificatin that the system installed r mdified, perfrms as intended thrughut the anticipated perating ranges and that the transfer frm the test envirnment t the live envirnment has been achieved withut crruptin f the system. 5.9 Perfrmance Qualificatin (PQ) The Perfrmance Qualificatin prvides dcumented verificatin f the perating perfrmance f the system in the live envirnment. This may be ver a specified time perid r based n specified number f data entries NWORTH: Telephne: nwrth@bangr.ac.uk

9 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 9 f Changes requested pst validatin Any change that is requested pst validatin will be evaluated using the change cntrl prcess t determine if it is a valid change that shuld be implemented. The change cntrl wrk instructin shuld be fllwed fr changes raised after the OQ has been cmpleted 5.11 Validatin Maintenance It is NWORTHs plicy t take a life cycle apprach t maintenance f a validated state. It is accmplished by use f change cntrl systems, and where applicable, peridic reviews f systems perfrmance. 6. Training plan fr SOP implementatin Training will be carried ut in accrdance with NWORTH training SOP Glssary f Terms Agile develpment Agile develpment is an umbrella term fr a number f iterative and incremental sftware develpment methdlgies, where user requirements are refined thrugh cllabratin between the develper and the user. Agile develpment methds fcus n shrter iteratins which help t prevent accumulating large backlg f defect t be crrected. Validatin is a dcumented prgramme that prvides a high degree f assurance that a facility r peratin will cnsistently prduce a prduct meeting a predetermined specificatin. It cnfirms that an peratin des what it purprts t d. 8. References Cmputer system validatin in Clinical Research a practical guide CSV%20Guidelines.pdf 9. Referenced SOPs NWORTH 2.01 training 10. Appendices Appendix 1 NWORTH: Telephne: nwrth@bangr.ac.uk

10 Date:07 June 2013 Versin 4 SOP number: 6.02 Page 10 f 10 Appendix 1 Assessing level f validatin System type Applicatin purpse Prvider Activity Infrastructure sftware (established r cmmercially available sftware including perating systems, ffice applicatins etc.) Widely used applicatin with n r simple cnfiguratin (text file) External Recrd versin number Less than 200 lines f cde 1 ff usage nncritical applicatin e.g. NWORTH Recrd versin number and cde. Prgram t extract address and then all users f a system. Less than 200 lines f cde Re useable small cde e.g. prgram t extract data frm randmisatin system. NWORTH Full Validatin Custm cde mre than 200 lines Any applicatin NWORTH Full Validatin Systems that the cde r part f the cde is cnfigurable. Applicatin that requires cmplex cnfiguratin / prgramming e.g. excel External Validate Develped Cde Systems that the cde r part f the cde is cnfigurable. e.g. Macr, Data integratin sftware. External Determine level f validatin prvider has cmpleted. Minimum requirements fr NWORTH IQ OQ NWORTH: Telephne: nwrth@bangr.ac.uk