#iqDMS

[postsofbabel]

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[asesinasworld]

[complianceg]

Document Control for Medical Device Companies

Article Context:

1.   eDMS

This morning I’m looking out the window of my home office, watching the palm fronds blow with a small lake in the background, at 70 degrees in Florida. What does that have anything to do with document control OR medical device companies?     Well, if I were my dad, who had open heart surgery in August, it would mean that if doc control hadn’t been in place, it’s very likely that the artificial valve put in his heart might be faulty and he wouldn’t get a chance to do Anything after his operation. He’s back to his old active self, enjoying views of the mountains and wildlife in Colorado, thanks to those who managed everything related to his artificial valve!     Part of that process is ensuring a document management system is in place, beyond just doc control. Ideally, it’s an electronic document management system since we’re well into the 21st Century now. Surprisingly, many companies are still on paper instead of the cloud.  

So what’s involved to get an eDMS in place?  

Many med device��companies do have some kind of document management system in place to produce a required design history file per the FDA’s 13485 guidelines. These companies also need to capture various forms of data from the contract manufacturing organization or CMO, including design verification along with validation testing of their eDMS. 

Additionally, design controls, equipment specifications, materials, and technician training need to be completed. All of this documentation is an integral part of product lifecycle management. 

Before any medical device can be released onto the market, the burden is on device producers to demonstrate that their product does what it’s supposed to. That can be an extremely labor-intensive process since the FDA demands Lots of paperwork documenting everything from the design process to manufacturing specifications. 

In particular, your CMO plays a critical role in developing and maintaining the device master record (DMR). The FDA will check the DMR against your design history record (DHR) to ensure consistency before your product goes to market. 

The DMR could contain thousands of lines of information for complex products. Your manufacturer should have a computerized system, such as product lifecycle management software, to create and maintain the information needed in the DMR. 

A traceability matrix is also invaluable for following the flow of med device   development from beginning to end. Traceability requires showing the relationships between all of your design controls, including how design inputs relate to design outputs and how design validations relate to end-user needs. 

As your customer base grows, so will the many needs of the above increase, and the need for an enterprise document management system. Welcome to Compliance Group’s iQuality eDMS/eQMS to handle all of these needs. https://iquality.ai   

Back to the potato analogy, if you were to compare another food, the hamburger, to QA and QC, it would look like this, thanks to Royal Chemical’s.

And this is why it’s so good to have proper people in place for QA and QC to make your product sizzle! And for burger lovers, who wouldn’t enjoy this kind of Quality Control testing a lot more!

Would you like to know more about Quality Assurance and Quality Control  process in your organization? Contact sales@complianceg.com to discuss your needs.

[poetryofchrist]

Here is Psalm 18 again with the ta`amei ha-mikra (accents) below the text interpreted as reciting notes and a few of the ornaments (ole is vital for the Psalms) as superscripts.

Psalms 18 Fn Min Max Syll Avg S/N לַמְנַצֵּ֤חַ ׀ לְעֶ֥בֶד יְהוָ֗ה לְדָ֫וִ֥ד אֲשֶׁ֤ר דִּבֶּ֨ר ׀ לַיהוָ֗ה אֶת־דִּ֭בְרֵי הַשִּׁירָ֣ה הַזֹּ֑את בְּי֤וֹם הִֽצִּיל־יְהוָ֘ה אוֹת֥וֹ מִכַּ֥ף כָּל־אֹ֝יְבָ֗יו וּמִיַּ֥ד שָׁאֽוּל 1 lmnxCk lyfbd ihvh ld<vfd awCr dbr lihvh at dgbri hwirBh hzAat biCom hexil ihvh aotfo mcfp cl aibiv umifd waeul 3e 4C 12 14 18 4 וַיֹּאמַ֡ר אֶרְחָמְךָ֖ יְהוָ֣ה חִזְקִֽי 2 viamr arkmcg ihvBh kzqei 3e 4B 10 2.5 יְהוָ֤ה ׀ סַֽלְעִ֥י וּמְצוּדָתִ֗י וּמְפַ֫לְטִ֥י אֵלִ֣י צ֭וּרִי אֶֽחֱסֶה־בּ֑וֹ מָֽגִנִּ֥י וְקֶֽרֶן־יִ֝שְׁעִ֗י מִשְׂ��ַּבִּֽי 3 ihvCh selyfi umxudti umf<l'tfi alBi xguri aeksh bAo megnfi vqern iwyi mwgbei 3e 4C 11 8 11 2.73 מְ֭הֻלָּל אֶקְרָ֣א יְהוָ֑ה וּמִן־אֹ֝יְבַ֗י אִוָּשֵֽׁעַ 4 g mghll aqrBa ihvAh umn aibi auwey 3e 4B 7 8 3.75 אֲפָפ֥וּנִי חֶבְלֵי־מָ֑וֶת וְֽנַחֲלֵ֖י בְלִיַּ֣עַל יְבַֽעֲתֽוּנִי 5 afffuni kbli mAvt venklgi bliByl ibeyteuni 3e 4B 7 13 2.86 חֶבְלֵ֣י שְׁא֣וֹל סְבָב֑וּנִי קִ֝דְּמ֗וּנִי מ֣וֹקְשֵׁי מָֽוֶת 6 kblBi waBol sbbAuni qdmuni mBoqwi mevt 3e 4B 8 7 3 בַּצַּר־לִ֤י ׀ אֶֽקְרָ֣א יְהוָה֮ וְאֶל־אֱלֹהַ֪י אֲשַׁ֫וֵּ֥עַ יִשְׁמַ֣ע מֵהֵיכָל֣וֹ קוֹלִ֑י וְ֝שַׁוְעָתִ֗י לְפָנָ֤יו ׀ תָּב֬וֹא בְאָזְנָֽיו 7 bxr lCi aeqrBa ihvh val alhi aw<ufy iwmBy mhiclBo qolAi vwvyti lfnCiv tboa bazneiv 3d 4C 16 8 12 3.6 וַתִּגְעַ֬שׁ וַתִּרְעַ֨שׁ ׀ הָאָ֗רֶץ וּמוֹסְדֵ֣י הָרִ֣ים יִרְגָּ֑זוּ וַ֝יִּתְגָּֽעֲשׁ֗וּ כִּי־חָ֥רָה לֽוֹ 8 vtgyw vtryw harx umosdBi hrBim irgAzu vitgeywu ci kfrh leo 3e 4B 17 8 4.17 עָ֘לָ֤ה עָשָׁ֨ן ׀ בְּאַפּ֗וֹ וְאֵשׁ־מִפִּ֥יו תֹּאכֵ֑ל גֶּ֝חָלִ֗ים בָּעֲר֥וּ מִמֶּֽנּוּ 9 ~ ylCh ywn bafo vaw mffiv tacAl gklim byrfu mmenu 3e 4C 13 9 4.4 וַיֵּ֣ט שָׁ֭מַיִם וַיֵּרַ֑ד וַ֝עֲרָפֶ֗ל תַּ֣חַת רַגְלָֽיו 10 viB't wgmim virAd vyrfl tBkt rgleiv 3e 4B 7 8 2.5 וַיִּרְכַּ֣ב עַל־כְּ֭רוּב וַיָּעֹ֑ף וַ֝יֵּ֗דֶא עַל־כַּנְפֵי־רֽוּחַ 11 vircBb yl cgrub viyAp vida yl cnfi reuk 3e 4B 9 7 3.2 יָ֤שֶׁת חֹ֨שֶׁךְ ׀ סִתְר֗וֹ סְבִֽיבוֹתָ֥יו סֻכָּת֑וֹ חֶשְׁכַת־מַ֝֗יִם עָבֵ֥י שְׁחָקִֽים 12 C iCwt kwc stro sbeibotfiv sctAo kwct mim ybfi wkqeim 3e 4C 13 8 3.5 מִנֹּ֗גַהּ נֶ֫גְדּ֥וֹ עָבָ֥יו עָבְר֑וּ בָּ֝רָ֗ד וְגַֽחֲלֵי־אֵֽשׁ 13 mngh n<gdfo ybfiv ybrAu brd vgekli aew 3e 4A 9 7 4 וַיַּרְעֵ֬ם בַּשָּׁמַ֨יִם ׀ יְֽהוָ֗ה וְ֭עֶלְיוֹן יִתֵּ֣ן קֹל֑וֹ בָּ֝רָ֗ד וְגַֽחֲלֵי־אֵֽשׁ 14 virym bwmim iehvh vgylion itBn qlAo brd vgekli aew 3e 4B 15 7 4.4 וַיִּשְׁ��ַ֣ח חִ֭צָּיו וַיְפִיצֵ֑ם וּבְרָקִ֥ים רָ֝ב וַיְהֻמֵּֽם 15 viwlBk kgxiv vifixAm ubrqfim rb vihmem 3e 4B 8 7 2.5 וַיֵּ֤רָא֨וּ ׀ אֲפִ֥יקֵי מַ֗יִם וַֽיִּגָּלוּ֮ מוֹסְד֪וֹת תֵּ֫בֵ֥ל מִגַּעֲרָ֣תְךָ֣ יְהוָ֑ה מִ֝נִּשְׁמַ֗ת ר֣וּחַ אַפֶּֽךָ 16 viCrau affiqi mim veiglu mosdot t<bfl mgyrBtcB ihvAh mnwmt rBuk afec 3d 4C 16 7 8 3.1 יִשְׁלַ֣ח מִ֭מָּרוֹם יִקָּחֵ֑נִי יַֽ֝מְשֵׁ֗נִי מִמַּ֥יִם רַבִּֽים 17 iwlBk mgmrom iqkAni iemwni mmfim rbeim 3e 4B 9 7 2.29 יַצִּילֵ֗נִי מֵאֹיְבִ֥י עָ֑ז וּ֝מִשֹּׂנְאַ֗י כִּֽי־אָמְצ֥וּ מִמֶּֽנִּי 18 ixilni maibfi yAz umwnai cei amxfu mmeni 3e 4A 8 10 3 יְקַדְּמ֥וּנִי בְיוֹם־אֵידִ֑י וַֽיְהִי־יְהוָ֖ה לְמִשְׁעָ֣ן לִֽי 19 iqdmfuni biom aidAi veihi ihvgh lmwyBn lei 3e 4B 8 9 2.43 וַיּוֹצִיאֵ֥נִי לַמֶּרְחָ֑ב יְ֝חַלְּצֵ֗נִי כִּ֘י חָ֥פֵֽץ בִּֽי 20 vioxiafni lmrkAb iklxni ci kffex bei 3e 4A 8 8 3.2 יִגְמְלֵ֣נִי יְהוָ֣ה כְּצִדְקִ֑י כְּבֹ֥ר יָ֝דַ֗י יָשִׁ֥יב לִֽי 21 igmlBni ihvBh cxdqAi cbfr idi iwfib lei 3e 4B 9 7 3.2 כִּֽי־שָׁ֭מַרְתִּי דַּרְכֵ֣י יְהוָ֑ה וְלֹֽא־רָ֝שַׁ֗עְתִּי מֵאֱלֹהָֽי 22 cei wgmrti drcBi ihvAh vlea rwyti malhei 3e 4B 7 8 3 כִּ֣י כָל־מִשְׁפָּטָ֣יו לְנֶגְדִּ֑י וְ֝חֻקֹּתָ֗יו לֹא־אָסִ֥יר מֶֽנִּי 23 B cBi cl mwf'tBiv lngdAi vkqtiv la asfir meni 3e 4B 8 8 4 וָאֱהִ֣י תָמִ֣ים עִמּ֑וֹ וָ֝אֶשְׁתַּמֵּ֗ר מֵעֲוֺנִֽי 24 vahBi tmBim ymAo vawtmr myv&#1466nei 3e 4B 7 8 3.75 וַיָּֽשֶׁב־יְהוָ֣ה לִ֣י כְצִדְקִ֑י כְּבֹ֥ר יָ֝דַ֗י לְנֶ֣גֶד עֵינָֽיו 25 viewb ihvBh lBi cxdqAi cbfr idi lnBgd yineiv 3e 4B 9 9 3 עִם־חָסִ֥יד תִּתְחַסָּ֑ד עִם־גְּבַ֥ר תָּ֝מִ֗ים תִּתַּמָּֽם 26 ym ksfid ttksAd ym gbfr tmim ttmem 3e 4A 6 8 2.8 עִם־נָבָ֥ר תִּתְבָּרָ֑ר וְעִם־עִ֝קֵּ֗שׁ תִּתְפַּתָּֽל 27 ym nbfr ttbrAr vym yqw ttftel 3e 4A 6 7 3.25 כִּֽי־אַ֭תָּה עַם־עָנִ֣י תוֹשִׁ֑יעַ וְעֵינַ֖יִם רָמ֣וֹת תַּשְׁפִּֽיל 28 cei agth ym ynBi towAiy vyingim rmBot twfeil 3e 4B 8 7 2.14 כִּֽי־אַ֭תָּה תָּאִ֣יר נֵרִ֑י יְהוָ֥ה אֱ֝לֹהַ֗י יַגִּ֥יהַּ חָשְׁכִּֽי 29 cei agth taBir nrAi ihvfh alhi igfih kwcei 3e 4B 6 10 2.67 כִּֽי־בְ֭ךָ אָרֻ֣ץ גְּד֑וּד וּ֝בֵֽאלֹהַ֗י אֲדַלֶּג־שֽׁוּר 30 cei bgc arBx gdAud ubealhi adlg weur 3e 4B 7 8 3 הָאֵל֮ תָּמִ֪ים דַּ֫רְכּ֥וֹ אִמְרַֽת־יְהוָ֥ה צְרוּפָ֑ה מָגֵ֥ן ה֝֗וּא לְכֹ֤ל ׀ הַחֹסִ֬ים בּֽוֹ 31 hal tmim d<rcfo amret ihvfh xrufAh mgfn hua lcCl hksim beo 3d 4C 6 7 9 2.44 כִּ֤י מִ֣י אֱ֭לוֹהַּ מִבַּלְעֲדֵ֣י יְהוָ֑ה וּמִ֥י צ֝֗וּר זוּלָתִ֥י אֱלֹהֵֽינוּ 32 C cCi mBi agloh mblydBi ihvAh umfi xur zultfi alheinu 3e 4C 11 10 3 הָ֭אֵל הַמְאַזְּרֵ֣נִי חָ֑יִל וַיִּתֵּ֖ן תָּמִ֣ים דַּרְכִּֽי 33 g hgal hmazrBni kAil vitgn tmBim drcei 3e 4B 8 7 2.5 מְשַׁוֶּ֣ה רַ֭גְלַי כָּאַיָּל֑וֹת וְעַ֥ל בָּ֝מֹתַ֗י יַעֲמִידֵֽנִי 34 mwuBh rggli cailAot vyfl bmti iymideni 3e 4B 9 10 3.17 מְלַמֵּ֣ד יָ֭דַי לַמִּלְחָמָ֑ה וְֽנִחֲתָ֥ה קֶֽשֶׁת־נְ֝חוּשָׁ֗ה זְרוֹעֹתָֽי 35 mlmBd igdi lmlkmAh venktfh qewt nkuwh zroytei 3e 4B 9 13 3.14 וַתִּתֶּן־לִי֮ מָגֵ֪ן יִ֫שְׁעֶ֥ךָ וִֽימִינְךָ֥ תִסְעָדֵ֑נִי וְֽעַנְוַתְךָ֥ תַרְבֵּֽנִי 36 vttn li mgn i<wyfc veimincf tsydAni veynvtcf trbeni 3d 4A 9 7 7 2.56 תַּרְחִ֣יב צַעֲדִ֣י תַחְתָּ֑י וְלֹ֥א מָ֝עֲד֗וּ קַרְסֻלָּֽי 37 trkBib xydBi tktAi vlfa mydu qrslei 3e 4B 7 8 3 אֶרְדּ֣וֹף א֭וֹיְבַי וְאַשִּׂיגֵ֑ם וְלֹֽא־אָ֝שׁוּב עַד־כַּלּוֹתָֽם 38 ardBop agoibi vawigAm vlea awub yd clotem 3e 4B 8 7 3 אֶ֭מְחָצֵם וְלֹא־יֻ֣כְלוּ ק֑וּם יִ֝פְּל֗וּ תַּ֣חַת רַגְלָֽי 39 g agmkxm vla iBclu qAum iflu tBkt rglei 3e 4B 8 6 2.8 וַתְּאַזְּרֵ֣נִי חַ֭יִל לַמִּלְחָמָ֑ה תַּכְרִ֖יעַ קָמַ֣י תַּחְתָּֽי 40 vtazrBni kgil lmlkmAh tcrgiy qmBi tktei 3e 4B 10 7 2.43 וְֽאֹיְבַ֗י נָתַ֣תָּה לִּ֣י עֹ֑רֶף וּ֝מְשַׂנְאַ֗י אַצְמִיתֵֽם 41 veaibi ntBth lBi yArp umwnai axmitem 3e 4B 9 6 3.75 יְשַׁוְּע֥וּ וְאֵין־מוֹשִׁ֑יעַ עַל־יְ֝הוָ֗ה וְלֹ֣א עָנָֽם 42 iwuyfu vain mowAiy yl ihvh vlBa ynem 3e 4B 8 7 3 וְֽאֶשְׁחָקֵ֗ם כְּעָפָ֥ר עַל־פְּנֵי־ר֑וּחַ כְּטִ֖יט חוּצ֣וֹת אֲרִיקֵֽם 43 veawkqm cyffr yl fni rAuk c'tgi't kuxBot ariqem 3e 4B 11 7 3 תְּפַלְּטֵנִי֮ מֵרִ֪יבֵ֫י עָ֥ם תְּ֭שִׂימֵנִי לְרֹ֣אשׁ גּוֹיִ֑ם עַ֖ם לֹא־יָדַ֣עְתִּי יַֽעַבְדֽוּנִי 44 tfl'tni mrib<i yfm tgwimni lrBaw goiAm ygm la idByti ieybdeuni 3d 4B 8 8 8 2.67 לְשֵׁ֣מַֽע אֹ֭זֶן יִשָּׁ֣מְעוּ לִ֑י בְּנֵֽי־נֵ֝כָ֗ר יְכַחֲשׁוּ־לִֽי 45 lwBmey agzn iwBmyu lAi bnei ncr ickwu lei 3e 4B 9 8 2.43 בְּנֵי־נֵכָ֥ר יִבֹּ֑לוּ וְ֝יַחְרְג֗וּ מִֽמִּסְגְּרֽוֹתֵיהֶֽם 46 bni ncfr ibAlu vikrgu memsgreotihem 3e 4A 6 10 4 חַי־יְ֭הוָה וּבָר֣וּךְ צוּרִ֑י וְ֝יָר֗וּם אֱלוֹהֵ֥י יִשְׁעִֽי 47 ki ighvh ubrBuc xurAi virum alohfi iwyei 3e 4B 9 8 2.83 הָאֵ֗ל הַנּוֹתֵ֣ן נְקָמ֣וֹת לִ֑י וַיַּדְבֵּ֖ר עַמִּ֣ים תַּחְתָּֽי 48 hal hnotBn nqmBot lAi vidbgr ymBim tktei 3e 4B 9 7 2.67 מְפַלְּטִ֗י מֵאֹ֫יְבָ֥י אַ֣ף מִן־קָ֭מַי תְּרוֹמְמֵ֑נִי מֵאִ֥ישׁ חָ֝מָ֗ס תַּצִּילֵֽנִי 49 mfl'ti ma<ibfi aBp mn qgmi trommAni mafiw kms txileni 3e 4B 6 8 8 3.14 עַל־כֵּ֤ן ׀ אוֹדְךָ֖ בַגּוֹיִ֥ם ׀ יְהוָ֑ה וּלְשִׁמְךָ֥ אֲזַמֵּֽרָה 50 yl cCn aodcg bgoifm ihvAh ulwmcf azmerh 3e 4C 9 7 2.29 מַגְדִּיל֮ יְשׁוּע֪וֹת מַ֫לְכּ֥וֹ וְעֹ֤שֶׂה חֶ֨סֶד ׀ לִמְשִׁיח֗וֹ לְדָוִ֥ד וּלְזַרְע֗וֹ עַד־עוֹלָֽם 51 mgdil iwuyot m<lcfo vyCwh ksd lmwiko ldvfd ulzryo yd yolem 3d 4C 7 17 4

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Iqdms athiwe

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Document Control for Medical Device Companies So what’s involved to get an eDMS in place?

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iQDMS is a professional and powerful Document Management System software. Compliance Group Provides Simple, electronic, efficient and secure document management using SOC 2 Type II and ISO 27001 certified iQDMS.

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How to improve efficiency with a Document Management System?

Companies look forward to increasing their productivity, accomplishing goals, and earning profits. To achieve it, handling business documents and files plays a critical role. When done right with streamlining the process and improving the efficiency of documents, it will enhance success possibilities as improper handling of documents and files leads to loss of critical company information and process deviations.

Documents talk about the organization’s procedures, policies, and processes. But, again, consolidating the paper documents, publishing, reviewing them, tracking their progress, validations, and proving their existences and retrieval when required for inspections is not easy. Moreover, complying with regulations handling paper documents is a hectic job.

Why is Document Management essential?

The FDA (Food and Drug Administration) sends out a Form 483 observation letter seeking evidence of quality processes handled by the organization. If not responded, a Warning Letter is issued, expecting audit-ready documentation proving the quality process.

Note: Form 483 Observation – an inspectional observation highlighting the regulatory violations related to process, equipment, procedure, controls, facility, etc. found during an inspection in an organization

With methods like change control, manufacturing procedures, medical device designing processes flowing in the life sciences industries, an efficient document handling process is necessary to manage documents effectively.

A Document Management System sets the company’s systematic process to support and streamline documents/files management, ensuring quality procedures and practices to help reduce regulatory risks.

iQDMS is an intelligent Document Management System that enables organizations to effectively manage quality documents like SOP’s, change controls, work instructions, manufacturing procedures, audit records, etc. It makes the document handling process easy with configurable metadata fields for generating a document and workflow states to process the document flow required by the organization.

So, let us discuss how to improve document handling efficiency with a Document Management System (DMS).

Configurable and Automated Workflows

Distributing and keeping track of documents is the most time-consuming process and is prone to human error and loss of information when not streamlined and appropriately managed, slowing the strategy and growth. The key to addressing this in document management is automation. DMS allows easy creation of documents and tracks the out-of-document changes with timestamps in audit trails, and the content/ information edits are tracked in version logs by check-out and check-in features. iQDMS (iQuality Document Management System) allows the users to access the documents whenever required and provides access to those who need them based on the RBAC (Role-Based Access Controls). This way, DMS streamlines and automates the document activity from one workflow state to another with validation checks notifying the users of their actions from creation to storage and distribution across the organization.

Segregation and Searching of Documents

Searching the paper-based documents in cabinets or scrolling through emails and desktop folders is a hassle, time-consuming, and can lead to unintended data exposure. The documents created are contexted automatically with identification numbers and configurable metadata fields for easy and advanced document search. DMS leveraging advanced filters and search options, documents are found with just a click.

Segregation of data is key to organizing the documents better that helps users with easy accessibility. In addition, it helps the organization to oversee its documents irrespective of their type on a single platform. Leveraging a potential document management system in the company is to limit the access of confidential documents and give access to those who can make informed decisions and resolve the company’s bottom line issues.

Easy Retrievals and Inspections

The search filters and documents sorting in specific variables make it easy to retrieve documents faster in DMS. In addition, the copy edits with timestamps and E-signatures of approvers who authorized the policies and procedures and those who did not agree to the company’s policies and their comments are captured and maintained in a non-editable audit log, making it accessible during inspections. Furthermore, the version history captures and stores the latest version of the current document while documenting the older versions with downloadable content for reference in PDF or source format.

Better Collaboration

Teamwork in the workplace maximizes success as it enables employees to work in coordination and share knowledge. However, when the business strategies, policies, and procedures spread across teams and multiple locations, collaboration can be complex when businesses rely on emails for distribution, reviewal, and approval of policies/procedures/documents. Hence integrating an intelligent document management system makes it easier for the organization to distribute and share documents to multiple recipients for feedback and input as it allows real-time collaboration. In addition, it enables the authorized access and approval of documents at any time.

Access Management

Security is a critical aspect of DMS, which resolves the need for digital protection of documents. It is about the authentication of the user’s login, restricted access, and e-signatures with passwords. With DMS, the organization has the power to grant access, read, write, and approve rights of the documents to users. In addition, the organization can decide who should have access to which document and to what level and how much access they should have. Also, the document owner has the privilege to monitor and track the changes of the author of the document having access.

Further, DMS being cloud-based ensures easy retrieval and backups of data. Unlike paper-based, flood, fire, and short circuits cannot destroy the documents. With redundant servers in place, there is no loss of information.

Conclusion – How iQDMS can improve compliance?

A DMS is vital for the life sciences industry to comply with the regulatory body. However, the compliance requirements of life sciences documents like policies, SOP’s, device designs, manufacturing procedures vary with document type and can be complex. Therefore, non-compliance with such documents results in legal issues and warning letters.

To conclude, implementing an intelligent document management system like iQDMS to manage and streamline business documents workflows saves resources, time, and money in compliance with the standard regulations.

Key benefits of iQDMS for an organization’s compliance:

Stores documents on the cloud with facilitated information backup and an easy retrieval process.

Role-Based Access Control (RBAC) ensures who should have access to the documents to what level and to what extent.

Non-editable Audit trails – Compliant with 21 CFR (Code of Federal Regulations) Part 11 captures micro edits of those who, when, how long they view the documents and what changes they have made with time stamps.

Automates workflow with validation checks of filling up the mandatory information.

Notify the users of required approvals of documents so that they are up to date with the information on documents.

Version history keeps track of all versions of a document while maintaining the information of each version of the document.

Secures E-Signatures of users who read, reviewed, approved/rejected the document/policy/process/procedure with comments.

Implementing a suitable DMS will make compliance an integral part of the organization’s day-to-day operations. In addition, it can save time by enabling real-time distributing, tracking, and collaboration of data.

To know more about how your organization could benefit from iQDMS, schedule a one-on-one call with our team by writing to us at sales@complinaceg.com.

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Document Control vs. Document Management

Information flow is evident in the life sciences industry, resulting in more unstructured data. Therefore, quality data is vital for effective and compliant operations as the industry’s regulations are data-driven. So, there are many documents to be managed and controlled with this. Often, people get confused about these terms – Document Control and Document Management. Though the terms are used interchangeably, there is a considerable difference between them.

In this blog, we shall discuss and highlight the differences between document control and document management as they are two distinct aspects and their importance in life sciences organizations.

What is Document Control ?

Document control is the process of maintaining documents enforcing controlled procedures and practices for creation, review and track document editions and accessibility. That is, it refers to the security and credibility aspects. Document control means securing documents, archived, and obsolete necessarily for the long term in a company’s operations. The documents created and gone through a solid approval workflow process are secured for a specific reason. When the organization requires any modification, the documented changes get tracked with time stamps and the user details who initiated the editions. The transformation might give a version increase and get separated from earlier versions or be tracked in the current version’s audit trail.

To keep the document control regulated, access to these documents is limited and outdated versions are archived. For certain users, only the latest versions are accessible. As a result, the controlled documents have a longer shelf life and shorter document life. In addition, the previous versions get updated, and the effective versions are made available to the users for training and use. Therefore, they are less prone to misuse and confidentially with all the comments and editions for compliance and audits.

In an organization, the document control process involves the following:

Secures the outdated document versions in the form of archival procedure

Documents aligned in the version history

The document reviewal and approval workflows are streamlined with e-signatures in compliance with 21 CFR Part 11 compliance.

Document control is vital for all industry types in Life Sciences. With iQDMS, document controlling is seamlessly accessible, keeping track of all documents in the workflow and archived versions with minimum effort also automating the document management process.

What is Document Management?

It might seem that document control plays a vital role with the above information, but that does not mean that document management is less critical in life sciences industries. In simple terms, document management is digitalizing the paper documents, creating them, indexing, validating, editing, and versions updating whenever required and storing them. So, this means that a controlled document is formerly a managed document in the system.

With iQDMS (iQuality’s Document Management System), document management is automatic with configurable workflows and metadata fields. For example, a document created in the system automatically gets indexed with an identification number, timestamp of the created date, and time and creator and owner information. In addition, the workflows are streamlined with e-signatures and non-editable audit logs making it easy to control the documents for inspections and audits. Furthermore, folders segregation, multi-tab view of data input, check-in, check-out functions to work collaboratively on a copy, document change tracking, content downloads, and print option facilitates traceability, search, and easy retrieval process.

Document Control Vs. Document Management – Which is essential for an organization?

Significantly, document management and document control are intricately connected, neither of which the process becomes invalid. Because without document management, there is no aspect of securing it where it means document control. Likewise, the organization lacks security and cannot comply without document control.

Concluding Thoughts

iQDMS is a holistic document management system that streamlines document handling processes like creation, tracking, updating, and securing documents. It is designed with top-notch features and tools required for the organization to manage and control documents in a regulated way effectively. The comprehensive and easy-to-use platform helps small-scale and enterprise-grade organizations to digitalize documents competitively. Regardless of the type and the number of documents, iQDMS can keep them secured and organized.

Learn more about how iQDMS functions and has to offer, reach our subject matter expert today at sales@complianceg.com

[complianceg]

How to improve efficiency with a Document Management System?

Companies look forward to increasing their productivity, accomplishing goals, and earning profits. To achieve it, handling business documents and files plays a critical role. When done right with streamlining the process and improving the efficiency of documents, it will enhance success possibilities as improper handling of documents and files leads to loss of critical company information and process deviations.

Documents talk about the organization’s procedures, policies, and processes. But, again, consolidating the paper documents, publishing, reviewing them, tracking their progress, validations, and proving their existences and retrieval when required for inspections is not easy. Moreover, complying with regulations handling paper documents is a hectic job.

Why is Document Management essential?

The FDA (Food and Drug Administration) sends out a Form 483 observation letter seeking evidence of quality processes handled by the organization. If not responded, a Warning Letter is issued, expecting audit-ready documentation proving the quality process.

Note: Form 483 Observation – an inspectional observation highlighting the regulatory violations related to process, equipment, procedure, controls, facility, etc. found during an inspection in an organization

With methods like change control, manufacturing procedures, medical device designing processes flowing in the life sciences industries, an efficient document handling process is necessary to manage documents effectively.

A Document Management System sets the company’s systematic process to support and streamline documents/files management, ensuring quality procedures and practices to help reduce regulatory risks.

iQDMS is an intelligent Document Management System that enables organizations to effectively manage quality documents like SOP’s, change controls, work instructions, manufacturing procedures, audit records, etc. It makes the document handling process easy with configurable metadata fields for generating a document and workflow states to process the document flow required by the organization.

So, let us discuss how to improve document handling efficiency with a Document Management System (DMS).

Configurable and Automated Workflows

Distributing and keeping track of documents is the most time-consuming process and is prone to human error and loss of information when not streamlined and appropriately managed, slowing the strategy and growth. The key to addressing this in document management is automation. DMS allows easy creation of documents and tracks the out-of-document changes with timestamps in audit trails, and the content/ information edits are tracked in version logs by check-out and check-in features. iQDMS (iQuality Document Management System) allows the users to access the documents whenever required and provides access to those who need them based on the RBAC (Role-Based Access Controls). This way, DMS streamlines and automates the document activity from one workflow state to another with validation checks notifying the users of their actions from creation to storage and distribution across the organization.

Segregation and Searching of Documents

Searching the paper-based documents in cabinets or scrolling through emails and desktop folders is a hassle, time-consuming, and can lead to unintended data exposure. The documents created are contexted automatically with identification numbers and configurable metadata fields for easy and advanced document search. DMS leveraging advanced filters and search options, documents are found with just a click.

Segregation of data is key to organizing the documents better that helps users with easy accessibility. In addition, it helps the organization to oversee its documents irrespective of their type on a single platform. Leveraging a potential document management system in the company is to limit the access of confidential documents and give access to those who can make informed decisions and resolve the company’s bottom line issues.

Easy Retrievals and Inspections

The search filters and documents sorting in specific variables make it easy to retrieve documents faster in DMS. In addition, the copy edits with timestamps and E-signatures of approvers who authorized the policies and procedures and those who did not agree to the company’s policies and their comments are captured and maintained in a non-editable audit log, making it accessible during inspections. Furthermore, the version history captures and stores the latest version of the current document while documenting the older versions with downloadable content for reference in PDF or source format.

Better Collaboration

Teamwork in the workplace maximizes success as it enables employees to work in coordination and share knowledge. However, when the business strategies, policies, and procedures spread across teams and multiple locations, collaboration can be complex when businesses rely on emails for distribution, reviewal, and approval of policies/procedures/documents. Hence integrating an intelligent document management system makes it easier for the organization to distribute and share documents to multiple recipients for feedback and input as it allows real-time collaboration. In addition, it enables the authorized access and approval of documents at any time.

Access Management

Security is a critical aspect of DMS, which resolves the need for digital protection of documents. It is about the authentication of the user’s login, restricted access, and e-signatures with passwords. With DMS, the organization has the power to grant access, read, write, and approve rights of the documents to users. In addition, the organization can decide who should have access to which document and to what level and how much access they should have. Also, the document owner has the privilege to monitor and track the changes of the author of the document having access.

Further, DMS being cloud-based ensures easy retrieval and backups of data. Unlike paper-based, flood, fire, and short circuits cannot destroy the documents. With redundant servers in place, there is no loss of information.

Conclusion – How iQDMS can improve compliance?

A DMS is vital for the life sciences industry to comply with the regulatory body. However, the compliance requirements of life sciences documents like policies, SOP’s, device designs, manufacturing procedures vary with document type and can be complex. Therefore, non-compliance with such documents results in legal issues and warning letters.

To conclude, implementing an intelligent document management system like iQDMS to manage and streamline business documents workflows saves resources, time, and money in compliance with the standard regulations.

Key benefits of iQDMS for an organization’s compliance:

Stores documents on the cloud with facilitated information backup and an easy retrieval process.

Role-Based Access Control (RBAC) ensures who should have access to the documents to what level and to what extent.

Non-editable Audit trails – Compliant with 21 CFR (Code of Federal Regulations) Part 11 captures micro edits of those who, when, how long they view the documents and what changes they have made with time stamps.

Automates workflow with validation checks of filling up the mandatory information.

Notify the users of required approvals of documents so that they are up to date with the information on documents.

Version history keeps track of all versions of a document while maintaining the information of each version of the document.

Secures E-Signatures of users who read, reviewed, approved/rejected the document/policy/process/procedure with comments.

Implementing a suitable DMS will make compliance an integral part of the organization’s day-to-day operations. In addition, it can save time by enabling real-time distributing, tracking, and collaboration of data.

To know more about how your organization could benefit from iQDMS, schedule a one-on-one call with our team by writing to us at sales@complinaceg.com.