Guidance Document: Selecting a Commercial Records Storage Provider

Transcription

1 G C P R e o r s M n g e r s A s s o i t i o n Guine Doument: Seleting Commeril Reors Storge Provier 1 Seleting Commeril Reors Storge Provier 1.1 Generl Remrks The following is heklist to ssist in the seletion n evlution of rhive storge filities, storge lotions n infrstruture, prtiulrly if these re ontrte to ommeril reors storge proviers This heklist is not intene to e omprehensive list of requirements n shoul not e interprete s "mntory" or "minimum". It ontins list of stnr onsiertions to mke when estlishing ommeril reors storge ontrt of suitle qulity These onsiertions go eyon the seletion of the physil reors storge fility s there re other spets tht re eqully importnt to ensure tht the servie will e suitle in its entirety for the ompny's requirements; it is just piee in the overll proess. The primry onsiertion to e me in the seletion of ommeril reors storge provier is to ontrt high qulity servies tht minimize risk n filitte ompline This heklist shoul e use in onjuntion with the Compny's internl rhiving n retrievls ontrols; it oes not negte the nee for these. Responsiility for ensuring the seurity n preservtion of- n ess to- the Compny's reors hel with ommeril reors storge proviers remins with the Compny n the funtion mnging the reors mngement servies. Internl reors mngement ontrols shoul ensure ommeril reors storge proviers eliver optimum enefit to the ompny. GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

2 1.2 Commeril Reors Storge Provier Seletion Proess Where they exist, the Compny shoul follow n use its internl SOPs regring the seletion of ommeril reors storge proviers. In ny event, the SOP (or other proess) for the seletion of thir-prty venors shoul ientify severl ommeril reors storge proviers n selet from them numer for evlution. Post evlution single ommeril reors storge provier shoul e sujet to omprehensive QA uit prior to mking finl eision The Compny shoul estlish whether or not the ommeril reors storge provier mnges reors for other phrmeutil ompnies or hs experiene or unerstning of pplile GxP stnrs. If not, the Compny shoul enquire whether or not the ommeril reors storge provier mnges reors for ompnies from other regulte inustries The Compny shoul utilise its own prourement eprtment to ommene prourement n tener negotitions The Compny shoul e minful uring the seletion proess tht low ost storge hrges shoul not e the min eterminnt of seletion of ommeril reors storge provier. There re host of other hrges tht must lso e onsiere. Moreover, stisftory long-term reltionship with the ommeril reors storge provier is of equl -if not greter- importne. Less out prie more out long-term working reltionship 2 Contrt 2.1 Generl The Compny shoul ensure tht onfientility greements re in ple with the ommeril reors storge provier efore ommening negotitions If the ontrt is written y the ommeril reors storge provier, the Compny shoul supplement this with ontrt n servie level greements to ensure tht the Compny's nees re eing met. The Compny shoul not ept the ommeril reors storge provier s ontrt without review n negotition. GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

3 2.1.3 The Compny shoul ensure tht speifie lotion is esignte for the Compny's reors. The ommeril reors storge provier must e ontrtully oun to notify n otin greement from the ompny efore moving its reors to lotion other thn the speifie lotion. Speifition of lotion. Oligtion to notify n otin greement from the Sponsor if ouments re move to nother lotion The Compny shoul ensure tht there is luse in the ontrt to stte tht the Compny's t n the Compny's reors re owne y the Compny. "Dt" n "reors" inlues ut is not limite to: physil reors, reor ontiners, roe informtion, mett, t out the Compny's reors hel on ommeril reors storge provier tses (e.g. historil movement t) n ll other informtion pture to ientify reors n their movements The Compny shoul ensure tht there is luse in the ontrt to stte tht islosure of the Compny's t n the Compny's reors to thir prties requires the Compny's prior, express onsent The Compny shoul ensure tht there is luse in the ontrt to stte tht the Compny's t n the Compny's reors re sujet to t protetion legisltion n my not e esse y ny prty other thn the Compny. 2.2 Priing The Compny shoul ensure tht osts re fixe for speifie perio (generlly one yer) n re ssoite with trnsprent inrement inex (e.g. the Consumer Pries Inex or Retil Pries Inex ) s ontrt termintion n swith of estlishe rhiving proeures will e expensive ue to internl n externl osts n efforts. 2.3 Insurne The Compny shoul therefore onsult with their own insurers to etermine n pproprite level of insurne to over the risks ssoite with the loss of reors (e.g. osts to reover or reonstrut reors). The stnr insurne offering from ommeril reors storge proviers overs only the slvge vlue of reors; this is insuffiient to ensure the reovery of lost reors. GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

4 2.4 Monitoring n Issue Hnling The Compny shoul estlish n esltion proeure with the ommeril reors storge provier to el with unforeseen irumstnes The Compny shoul gree in vne the proess with the ommeril reors storge provier for hnling n oumenting hnges to the ontrt fter the ontrt hs een let. Hnling n oumenting hnges in the proess, fter signing ontrt The Compny shoul estlish single point of ontt with the ommeril reors storge provier for ll enquiries n k-up to ontts on oth sies. 2.5 Contrt Termintion The Compny shoul ensure tht stisftory mehnisms n ontrols re estlishe regring ny future lrge volume trnsfers or relotions, prtiulrly in reltion to ulk withrwls or ontrt termintion The Compny shoul gree in vne the hrges regring ny future lrge volume trnsfers or relotions, prtiulrly in reltion to ulk withrwls or ontrt termintion. 3 Compny Detils 3.1 Generl The Compny shoul stisfy itself tht the ommeril reors storge provier: hs een in the ommeril reors storge usiness for stisftory perio. In orer not to isvntge newly estlishe ommeril reors storge provier or one for whom no referrl informtion or history is ville, the Compny my hoose to institute loser level of monitoring; GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

5 e f g hs suffiient (inter)-ntionl spre to ter for the Compny's urrent n future nees. It shoul e note tht t protetion issues my pply if the ommeril reors storge provier wishes to store t in n inpproprite jurisition; hs suffiient long-term, full-time, ppropritely trine employees to ter for the Compny's urrent n future nees. A high turnover of stff woul inite trnsient stff who my e employe vi n geny or on short-term ontrt n who my onsequently e less qulifie, less experiene or less trine thn employees of the ommeril reors storge provier. hs suffiient emonstrle experiene s ommeril reors storge ontrtor to ter for the Compny's urrent n future nees hs experiene of eing le to stisftorily respon to offiil uits y regultory oies hs the ility to seurely hnle highly onfientil reors hs the ility to hnle reors of high intelletul property worth 3.2 Stff Qulifition (Speifilly for Involve Sites/Filities) The Compny shoul stisfy itself tht the ommeril reors storge provier hs eviene: tht estlishe proesses re in ple regring stff seletion tht estlishe proesses re in ple regring stff vetting tht estlishe proesses re in ple regring su-ontrting regring stff retention n volumes of temporry stff GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

6 e of estlishe proesses to ensure tht stff re ppropritely trine n qulifie for their roles. NB Aess ton hnling of- iniviul GxP ouments will require ifferent qulifitions over n ove the logistil hnling of sele oxes. 3.3 Qulity Mngement The Compny shoul stisfy itself tht the ommeril reors storge provier hs eviene: of suffiient qulity ontrol systems eing estlishe n followe (e.g. QA funtion, written proeures, trining progrmme) tht relevnt stnrs re institute in ll pplile lotions (e.g. ISO-9001, ISO-11799, GLP ertifite) 4 Risks n Risk Mitigtion 4.1 Generl The Compny shoul stisfy itself tht the ommeril reors storge provier hs in ple stisftory: risk mngement mesures n plns usiness ontinuity plns 4.2 Environment The Compny shoul stisfy itself tht the ommeril reors storge provier is lote t site tht is suffiiently istnt of free of potentil hzrs pose y: mjor trnsport routes (e.g. rilwys, irports, motorwys) mjor wterwys (e.g. nls, lkes, rivers, ses, floo plins) GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

7 inustries or servies using voltile sustnes (e.g. petroleum, gs) the nturl environment (e.g. floo plins, mrshes, forests) 4.3 Filities The Compny shoul stisfy itself tht eh of the ommeril reors storge provier premises (in loing oks n nillry opertionl res): e f g is uilt or pte to e suitle for storing reors (purpose-uilt, stn-lone uilings without seprte floors re preferle). is esigne to prevent or minimize risks (e.g. wetherproof, wterproof, fire-resistnt, vermin proof, protete ginst intrusion) hs fility supply systems seprte from the storge re (e.g. heting, eletriity, wter, sewerge et) Is suffiiently protete (e.g. wether protetion, fire, seurity) is sujet to regulr oumente mintenne (e.g. lrms) is stisftorily mintine (e.g. len, tiy n uniform in pperne) is ple of storing non-stnr size items, shoul the nee rise 4.4 Seurity The Compny shoul stisfy itself tht eh of the ommeril reors storge provier premises (in loing oks n nillry opertionl res) offers stisftory seurity for: perimeter ess (e.g. ring fene, seurity gtes, properly mnge) GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

8 internl wrehouse ess (e.g. iometri, keyp, swipe r et) whih shoul e restrite to nominte iniviuls n e le to proue reor of ess to the rhive inluing stff nme n time of ess visitors (who shoul e heke, oumente n esorte ll times) site n uiling ess (whih shoul inlue monitoring vi regulrly servie motion etetors, CCTV surveillne, seurity gurs, lrm systems onnete to polie sttion or seurity servie) 4.5 Fire The Compny shoul stisfy itself tht eh of the ommeril reors storge provier premises (in loing oks n nillry opertionl res) offers stisftory protetion ginst fire y: e f g h i j prohiiting smoking in working n storge res limiting potentil soures of [prtiulrly flmmle] heting evies (eg storge heters) prohiiting the storge of explosive or inflmmle mterils the instlltion of fire-rte wlls n oors ensuring tht stff re trine in fire etetion n suppression regulr ssessment n inspetion y the fire servie. loting fire extinguishers & hoses ppropritely hving suffiiently esigne utomte, intelligent sprinkler systems n smoke etetors in ple hving shelves n storge rks onstrute of fire resistnt mterils hving fire/het/smoke etetion n lrm systems instlle n onnete to nerest fire sttion GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

9 k l hving regulrly teste n oumente lrm tests hving gs fire suppression protete rooms e.g. using Inergen/FM200 or similr (if require) 4.6 Floo The Compny shoul stisfy itself tht eh of the ommeril reors storge provier premises (in loing oks n nillry opertionl res) offers stisftory protetion ginst floo y: hving suffiient spe etween floor n shelves to protet ginst risks from the groun (floo, fire wter) voiing overhe wter servies in the floor ove (eg wter pipes, servie pipes n sewerge pipes) hving storge res tht re not lote in n re lower thn the surrouning groun (sement) hving wter sensors/etetors instlle, mintine, inspete n teste 4.7 Storge Conitions The Compny shoul stisfy itself tht eh of the ommeril reors storge provier premises (in loing oks n nillry opertionl res where relevnt) offers stisftory storge onitions tht: e llow the estlishment of Compny eite spe (to mitigte ginst loss this is NOT reommene) provie suffiient pity for future nees hve suffiient ontrols in ple to prevent ross-ontmintion o not permit the storge of non-pper items with pper reors provie shelving of suffiient qulity in terms of uil, mterils, nhorge n hzr resistne GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

10 f g h i offer temperture & humiity ontrols tht re regulrly monitore, mintine n reore ( log of mesurement reorings n CAPA reors shoul e mintine) llow ir to irulte to provie suffiient ventiltion n prevent moul, ust n other pollutnts enefit from regulrly onute n oumente pest monitoring progrm offer environmentlly soun filities for eletroni mei storge if require tht meet pplile stnrs liste in the stnrs ppenix. 4.8 Business Continuity The Compny shoul stisfy itself tht the ommeril reors storge provier hs oumente eviene of: plns for isster response n reovery, whih shoul exten eyon personnel sfety n inlue ll spets of usiness ontinuity). The ommeril reors storge provier shoul provie oumenttion to emonstrte tht the plns hve een teste n psse ontrts n/or reltionships with oument reovery proviers in the event of mge to the Compny's ouments GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

11 5 Storge Logistis 5.1 Storge The Compny shoul stisfy itself tht the ommeril reors storge provier hs oumente eviene of: e proeures tht prevent the reors eing ientifie s elonging to the Compny (s first line of efene to protet itself, the Compny shoul use unmrke reors n oxes n permit only non-compny speifi, unique ientifier n roe to e ffixe to its reors n oxes). the lotions of multiple sites t whih the Compny's reors re lote (where permitte) the proeures use y the ommeril reors storge provier uring reors retrievl, espeilly proeures to ensure onfientility when retrieving loose files from oxes n when repling mge oxes (these proeures shoul inlue instrutions for otining written uthoristion from the Compny to el with oxes tht re seurity sele) the proeures use when hnling reors to ensure tht they re hnle with re n pproprite equipment the mesures in ple to voi short n long term mge to the reors (refer to the snrs liste in Appenix1) 5.2 Reors Ingestion/Inventory The Compny shoul stisfy itself tht the ommeril reors storge provier hs oumente eviene of: the tehniques n proesses employe to pture the movements of reors, inluing inherent mehnisms use to ensure qulity, prevent errors n mitigte ginst risk. The mehnisms will inlue ut not e limite to: roes or RFID lels n ompnying reers GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

12 e f tses n IT systems (in vlition, kup n reovery proeures, usiness ontinuity plnning) proeures mehnisms in ple to pture itionl mett e.g. (prout nme, oument type, retention perio) the pplition use y the ommeril reors storge provier to trk reors n whether or not this is interoperle with the Compny's reors trking system (e.g. roe reility) proeures use to generte reports n ny ssoite osts so tht the Compny n effet perioi reonilition reports 5.3 Trnsfers The Compny shoul stisfy itself tht the ommeril reors storge provier n provie oumentry eviene tht: it mintins uitle hin of ustoy oumenttion (e.g. rel-time trking reeipts n reports) no ouments or reors re left in vehiles overnight.. only own trnsport or Compny pprove ouriers re use to trnsport reors. The irumstnes uner whih trnsporttion my e su-ontrte shoul e gree prior to use. the use of trnsport hus use for elivery n olletion is equtely ontrolle y proeures (e.g. vi flowhrt) NB For GCP reors prtiulrly, the use of hus is not reommene not lest euse the hu storge filities my not hve een sujet to evlution, inspetion or uit n my not provie suitle seurity, protetion or environmentl onitions. GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

13 6 Servies 6.1 Generl The Compny shoul stisfy itself tht the ommeril reors storge provier provies: e hours of opertion suite to the Compny's nees methos of opertion n ommunitions suite to the Compny's nees (e.g. e-mil, telephone, fx, we-se online orering, ll entres, iret to site) equte rrngements for emergeny out of hours eliveries mximum retrievl times for regulr n urgent eliveries n olletions filities for viewing oxes on site 6.2 Supplies The Compny shoul stisfy itself tht the ommeril reors storge provier provies: supplies of suitle qulity n prie (e.g. oxes, files, lels, roes) NB It is not reommene tht the Compny purhses seurity sels from the ommeril reors storge provier sels stisftory elivery timesles on supplies oxes esigne to permit the use of seurity sels without using mge to the ox GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

14 6.3 Inexing The Compny shoul onfirm with the ommeril reors storge provier: the level n ost of ny inexing the Compny requires the ommeril reors storge provier to unertke 6.4 Retrievl The Compny shoul stisfy itself tht the ommeril reors storge provier provies: tse of the Compny's reors tht is essile to the Compny for the purposes of orering olletions n eliveries n mintining stok reor n n uitle history of the movements of the Compny's reors NB For seurity n onfientility resons it is reommene tht the Compny provies the ommeril reors storge provier with miniml informtion regring the ontent of the Compny's reors perioi reports on the Compny's reors. The formt n hrges ssoite with these reports shoul e gree up front 6.5 Delivery/Colletion The Compny shoul stisfy itself tht the ommeril reors storge provier provies: sme y eliveries n olletions urgent eliveries within gree timelines orering vi n online we portl, e-mil or telephone or omintion of one or mny tht onform to the Compny's seurity requirements eite elivery vn n ourier servies (these my e stellite trke) GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v

15 6.6 Destrution The Compny shoul stisfy itself tht the ommeril reors storge provier provies: if require, seure, onfientil n environmentlly responsile estrution servies tht inlues the provision of ertifites of estrution n re omplint with pplile stnrs (plese refer to Appenix 1) Stnrs Appenix BS 5454:2000 Reommentions for the storge n exhiition of rhivl ouments BS 1153:1992 Reommentions for proessing n storge of silver-geltine-type mirofilm BS EN 15713:2009 Seure estrution of onfientil mteril: Coe of prtie ISO 9706:1994 Informtion n oumenttion: Pper for ouments -requirements for permnene ISO 11799:2003 Informtion n oumenttion: Doument storge requirements for rhive n lirry mterils ISO 16245:2009 Informtion n oumenttion: Boxes, file overs n other enlosures, me from ellulosi mterils, for storge of pper n prhment ouments MHRA GLP Guine on Arhiving GCP-RMA Guine Doument: Seleting Commeril Reors Storge Provier v