Electronic Batch Record Management (EBR management) Ph21 Services Ltd. In cooperation with Charles Ischi AG .

Electronic Batch Record Electronic Batch Record ManagementManagement

(EBR management)(EBR management)

Ph21 Services Ltd.Ph21 Services Ltd.

In cooperation withIn cooperation with

Charles Ischi AGCharles Ischi AG

www.ph21.com

2

Myself & CompanyMyself & Company Guenther LoefflerGuenther Loeffler

• Director/Owner of Ph21 Services Ltd.Director/Owner of Ph21 Services Ltd.

Ph21 Services Ltd.Ph21 Services Ltd.• Founded Jan. 2009 as an English registered Limited in Founded Jan. 2009 as an English registered Limited in coursecourse

of an outsourcing of the PC Software branch from irl Industries. of an outsourcing of the PC Software branch from irl Industries. GmbH, Seeheim-JugenheimGmbH, Seeheim-Jugenheim

Location of Operation: Germany Location of Operation: Germany Field of OperationField of Operation

• Lifecycle support for the Ph21 software systemLifecycle support for the Ph21 software system• Second-level support to re-sellers, training, system validationSecond-level support to re-sellers, training, system validation• Ph21-related consulting servicePh21-related consulting service• Sales of Ph21 software licenses to re-sellersSales of Ph21 software licenses to re-sellers

3

ScopeScope

These subjects will be covered:These subjects will be covered:

• What are electronic batch records (EBRs)?What are electronic batch records (EBRs)?• Production volumes and amount of batch recordsProduction volumes and amount of batch records• EBRs and a safe/secure data managementEBRs and a safe/secure data management

Excerpt from 'FDA Electronic Submissions Gateway'Excerpt from 'FDA Electronic Submissions Gateway' Typical test system usagesTypical test system usages Data safety consequencesData safety consequences Data safety from the source to the destinationData safety from the source to the destination What often is overlookedWhat often is overlooked The flipside of the coinThe flipside of the coin System validation aspectsSystem validation aspects Is there a 'cheap' way for EBRs?Is there a 'cheap' way for EBRs?

• The 'real' benefits of EBRSsThe 'real' benefits of EBRSs• ConclusionsConclusions• Q&A / DiscussionQ&A / Discussion

4

What are electronic batch records?What are electronic batch records?

• streamlined manufacturing testing work practicesstreamlined manufacturing testing work practices operator is 'guided' through the testing processoperator is 'guided' through the testing process

• reduced complexity in the manufacturing testing processreduced complexity in the manufacturing testing process automatic sampling, testingautomatic sampling, testing

• embeds knowledge of the testing process to reduce future training embeds knowledge of the testing process to reduce future training costscosts

special testing instructions can be embedded into the batch record special testing instructions can be embedded into the batch record (batch/test comments)(batch/test comments)

• provides a centralized, controlled repository for all executed batch test provides a centralized, controlled repository for all executed batch test records and related data for easy batch reviewrecords and related data for easy batch review

• provides a full audit trail history of production test dataprovides a full audit trail history of production test data

• reduces errors, omissions and deviationsreduces errors, omissions and deviations example: disi Pharmacopoeia proceduresexample: disi Pharmacopoeia procedures

EBR is the idea to document the EBR is the idea to document the completecomplete batch batch production run no more in paper form but instead as production run no more in paper form but instead as ''electronic records'''electronic records'

proposed advantages of EBRs could/should be:proposed advantages of EBRs could/should be:

5


• enables a comprehensive batch report with easy, secure data accessenables a comprehensive batch report with easy, secure data access test results from different test devices can be accumulated into test results from different test devices can be accumulated into

one batch reportone batch report

• electronic information is generated anyway from SCADA to ERP electronic information is generated anyway from SCADA to ERP Systems (needs only to be collected)Systems (needs only to be collected)

• reduced archival cost (compared to paper filing)reduced archival cost (compared to paper filing)

• easier exchange with governmental authorities (FDA)easier exchange with governmental authorities (FDA)

• easier access to historic data (free text searches like on the Internet)easier access to historic data (free text searches like on the Internet)

• enables process optimizationenables process optimization data warehouse, data mining, statistical process controldata warehouse, data mining, statistical process control

• ‘‘save the trees’ / environmental considerationssave the trees’ / environmental considerations

6


A complete EBR may contain the following data items:A complete EBR may contain the following data items:

recipe/method parameters of the productrecipe/method parameters of the product production parametersproduction parameters ambient conditionsambient conditions batch testing resultsbatch testing results Quality assessmentsQuality assessments Others (batch release information etc.)Others (batch release information etc.)

7


EBR's may/will contain data from all production levels as:EBR's may/will contain data from all production levels as:

from the Enterprise Ressource Management / ERPfrom the Enterprise Ressource Management / ERP from the Manufacturing Execution System / MESfrom the Manufacturing Execution System / MES from the from the Supervisory Control and Data Acquisition / Supervisory Control and Data Acquisition / SCADASCADA from Programmable Logic Controller / PLCsfrom Programmable Logic Controller / PLCs from the Laboratory Information Management System / LIMSfrom the Laboratory Information Management System / LIMS from other data sourcesfrom other data sources

8


Valid EBRs have to be authentic and authorized!Valid EBRs have to be authentic and authorized!

The submission of electronic documents to the FDA is defined in:The submission of electronic documents to the FDA is defined in:• FDA Electronic Submissions Gateway (ESG) documentationFDA Electronic Submissions Gateway (ESG) documentation

The safe care to be taken on EBRs is documented in:The safe care to be taken on EBRs is documented in:• FDA's CFR - Code of Federal Regulations Title 21 (in short: 21CFR-11)FDA's CFR - Code of Federal Regulations Title 21 (in short: 21CFR-11)

A German legislative counterpart for digital signatures is:A German legislative counterpart for digital signatures is:• Gesetz über Rahmenbedingungen für elektronische Signaturen Gesetz über Rahmenbedingungen für elektronische Signaturen

(Signaturgesetz - SigG)(Signaturgesetz - SigG)

9


Special (Ph21-oriented) View on EBRsSpecial (Ph21-oriented) View on EBRs

in the view of the Ph21 system a batch record is an electronic dataset in the view of the Ph21 system a batch record is an electronic dataset which contains information about:which contains information about:

tablet testing methods with:tablet testing methods with:• nominal/target valuesnominal/target values• tolerance limitstolerance limits• sampling sizes, sampling intervalssampling sizes, sampling intervals

the acquired test results themselvesthe acquired test results themselves statistically evaluated valuesstatistically evaluated values good/bad quality assessmentsgood/bad quality assessments audit trail informationaudit trail information alarm conditions which occurred during the production runalarm conditions which occurred during the production run

10



EBRs of the Ph21 system may contain values from the following devices:EBRs of the Ph21 system may contain values from the following devices:• Universal tablet testers (UTS) acquiring weight, thickness, diameter, hardnessUniversal tablet testers (UTS) acquiring weight, thickness, diameter, hardness• Automatic tablet weighing systems (CIW)Automatic tablet weighing systems (CIW)• Bench top tablet hardness testers (e.g. HC 6.2)Bench top tablet hardness testers (e.g. HC 6.2)• Laboratory balances (Mettler, Sartorius)Laboratory balances (Mettler, Sartorius)• Calipers and gauges (Mitutoyo)Calipers and gauges (Mitutoyo)• Manually entered values from friabalilator or other equipment without data interfaceManually entered values from friabalilator or other equipment without data interface

11



Every batch record is Every batch record is uniquelyuniquely designated and can be retrieved easily designated and can be retrieved easily (by providing Product-name, -code, -No., Batch name, -code or any (by providing Product-name, -code, -No., Batch name, -code or any other search criteria)other search criteria)

A typical Ph21 Single Batch Report

C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\1_00000020.pdf

12


what we learnedwhat we learned

Because the production line delivers information in electronic Because the production line delivers information in electronic form, EBRs are essential for an up-to-date production form, EBRs are essential for an up-to-date production documentationdocumentation

The more quality- and production related information is The more quality- and production related information is contained in an EBR the more valuable it is for performance contained in an EBR the more valuable it is for performance analysis, process optimization etc.analysis, process optimization etc.

13

*** Production volumes and *** Production volumes and amounts of batch records ***amounts of batch records ***

Tablet batch manufacturing can/will produce Tablet batch manufacturing can/will produce hugehuge amounts of tablets / test data / electronic records.amounts of tablets / test data / electronic records.

14

Production volumes and Production volumes and amounts of batch recordsamounts of batch records

An ExampleAn Example

let's have a typical product/data volume of:let's have a typical product/data volume of:

10 tablet presses working 24/710 tablet presses working 24/7• a new batch starts every 3 hoursa new batch starts every 3 hours• a sample of 20 objects is taken/tested every 15 minutes from each a sample of 20 objects is taken/tested every 15 minutes from each

batchbatch• four values (weight, thickness, diameter, hardness) will be taken from four values (weight, thickness, diameter, hardness) will be taken from

each objecteach object

15


From the view of From the view of test test data volumes this evaluates data volumes this evaluates to:to:

a new tablet test is executed every 90 secondsa new tablet test is executed every 90 seconds 40 tablet tests executed per hour40 tablet tests executed per hour 960 tablet tests executed per day960 tablet tests executed per day 350,400 tablet tests executed per year350,400 tablet tests executed per year

16


From the view of From the view of batchbatch data volumes this data volumes this evaluates to:evaluates to:

80 batches produced per day80 batches produced per day 29,200 batches produced per year29,200 batches produced per year

17


After years of production huge amounts of data will After years of production huge amounts of data will have accumulated.have accumulated.

According to our previous manufacturing example According to our previous manufacturing example we will have stored:we will have stored:

29,200 batch records every year29,200 batch records every year each batch record contains 12 tablet tests with 80 values each batch record contains 12 tablet tests with 80 values

of weight, thickness, diameter and hardness eachof weight, thickness, diameter and hardness each which evaluates to 28,032,000 individually which evaluates to 28,032,000 individually

measured/acquired values per yearmeasured/acquired values per year

18


What we learnedWhat we learned

From the above numbers we can see that searching for a single From the above numbers we can see that searching for a single (probably 'bad') test result could be tedious if this data would (probably 'bad') test result could be tedious if this data would only be available on printed paperonly be available on printed paper

By using off-the-shelf personal computers and EBRs this is a By using off-the-shelf personal computers and EBRs this is a matter of a few secondsmatter of a few seconds

19

*** EBRs and a safe/secure data *** EBRs and a safe/secure data management ***management ***

Excerpt from ‘FDA Electronic Submissions Gateway Excerpt from ‘FDA Electronic Submissions Gateway (ESG), Appendix C’(ESG), Appendix C’

Encrypting and digitally signing documents using certificates provides Encrypting and digitally signing documents using certificates provides the following assurances about document transmissions:the following assurances about document transmissions:

• Only the addressee (and no unauthorized users) can read the message. Only the addressee (and no unauthorized users) can read the message. Encryption provides this assurance. Encryption provides this assurance.

• The message cannot be tampered with. That is, data cannot be changed, The message cannot be tampered with. That is, data cannot be changed, added, or deleted without the sender’s knowledge. A document’s digital added, or deleted without the sender’s knowledge. A document’s digital signature provides this assurance. signature provides this assurance.

• Parties sending documents are genuinely who they claim to be. Likewise, Parties sending documents are genuinely who they claim to be. Likewise, when those parties receive documents signed by the sender, they can be when those parties receive documents signed by the sender, they can be confident about the source of the documents. A document’s digital confident about the source of the documents. A document’s digital signature provides this assurance. signature provides this assurance.

• The parties who send documents cannot readily claim they did not send The parties who send documents cannot readily claim they did not send them. This is referred to as non-repudiation of origin. A document’s digital them. This is referred to as non-repudiation of origin. A document’s digital signature provides this assurance. signature provides this assurance.

• Parties who are sent documents cannot readily claim they did not receive Parties who are sent documents cannot readily claim they did not receive them. This is referred to as non-repudiation of receipt. The signed them. This is referred to as non-repudiation of receipt. The signed document acknowledgment provides this assurance. document acknowledgment provides this assurance.

20

EBRs and a safe/secure data EBRs and a safe/secure data managementmanagement

Typical test system usagesTypical test system usages

(A) the 'traditional' test lab, a 'standalone' tablet testing system with:(A) the 'traditional' test lab, a 'standalone' tablet testing system with:• manual test executionmanual test execution• test report printing, handwritten signing off the report, manual filingtest report printing, handwritten signing off the report, manual filing• all EBRs are stored on a 'standalone' ph21 test system and will not be all EBRs are stored on a 'standalone' ph21 test system and will not be

exchanged with the 'outside world'exchanged with the 'outside world'

(B) the next step, inter-connected systems within Ph21 environment(B) the next step, inter-connected systems within Ph21 environment• several Ph21 test systems inter-connected probably also with an Ph21 'Admin' several Ph21 test systems inter-connected probably also with an Ph21 'Admin'

systemsystem• automatic samplingautomatic sampling• alarm generationalarm generation

(C) further integration(C) further integration• EBRs stored on a central data collector / probably a centralized database is EBRs stored on a central data collector / probably a centralized database is

usedused• integration into an existing corporate's Sql-Server infrastructureintegration into an existing corporate's Sql-Server infrastructure• Integration into a corporate’s laboratory management or product planning Integration into a corporate’s laboratory management or product planning

system (LIMS integration)system (LIMS integration)

21


Data safety consequences for the three methods of test Data safety consequences for the three methods of test system usagesystem usage

(A) for the 'traditional' test lab, no security problems arise with data security, (A) for the 'traditional' test lab, no security problems arise with data security, because the test system is a closed /self-contained system. All data which is because the test system is a closed /self-contained system. All data which is extracted from the systems is printed on paper reportsextracted from the systems is printed on paper reports

(B) also for multiple, inter-connected Ph21 systems no problems will arise, (B) also for multiple, inter-connected Ph21 systems no problems will arise, because data exchange between the Ph21 systems is performed via Ph21 because data exchange between the Ph21 systems is performed via Ph21 proprietary encrypted and therefore temper-proof data recordsproprietary encrypted and therefore temper-proof data records

(C) in further integrated systems with direct access to the Ph21 database by the (C) in further integrated systems with direct access to the Ph21 database by the user of the system bears some security risks. In this case it is in the user of the system bears some security risks. In this case it is in the responsibility of the user to provide the adequate safeguards (e.g. access responsibility of the user to provide the adequate safeguards (e.g. access control, encryption and/or signature mechanisms)control, encryption and/or signature mechanisms)

22


in the case of an integration into a customer's LIMS system the Ph21 in the case of an integration into a customer's LIMS system the Ph21 provides a 'batch export' feature. This export of EBRs in its initial state is provides a 'batch export' feature. This export of EBRs in its initial state is performed by non-protected, plain text files. The file formats are performed by non-protected, plain text files. The file formats are documented.documented.

• To protect/secure this EBR files, a data encryption / signature procedures will be To protect/secure this EBR files, a data encryption / signature procedures will be employed by the supplier of the systememployed by the supplier of the system

• The kind of encryption, signature and the data content / data formats has to be The kind of encryption, signature and the data content / data formats has to be agreed between the supplier and the user of the Ph21 system!agreed between the supplier and the user of the Ph21 system!

23


Data safety from the Data safety from the sourcesource to the destination to the destination

Test equipment ( the data source) should provide:Test equipment ( the data source) should provide:• Fine-grained access control functionsFine-grained access control functions• Data stamping (date, time, origin, responsible user)Data stamping (date, time, origin, responsible user)• Traceability, versioning/change control of data recordsTraceability, versioning/change control of data records• Device self test featuresDevice self test features• Calibration expiry supervisionCalibration expiry supervision

24


What often is overlookedWhat often is overlooked

Test equipment should provide:Test equipment should provide:• Safe/secure data transmission (RS232 is NOT a safe data Safe/secure data transmission (RS232 is NOT a safe data

transmission method)transmission method)

Information Data flow

C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Chain_of_Data_Flow.bmp

25


The flipside of the coinThe flipside of the coinelectronically signed EBRs (like human handwritten signedelectronically signed EBRs (like human handwritten signeddocuments) can still be falsified (signatures can be cracked,documents) can still be falsified (signatures can be cracked,hacked)hacked)

As an Example the ‘DES’-57 bit cryptographic algorithm:As an Example the ‘DES’-57 bit cryptographic algorithm:

• released 1977released 1977

• first cracked 1997first cracked 1997

• replaced with Triple-DES 1999replaced with Triple-DES 1999

• AES becomes effective 2002AES becomes effective 2002

• Triple-DES withdrawn by NIST 2005 in favour for AESTriple-DES withdrawn by NIST 2005 in favour for AES

replacement of an 'unsafe' signature with a safe one may/will replacement of an 'unsafe' signature with a safe one may/will require considerable revalidation effortrequire considerable revalidation effort

26


System Validation AspectsSystem Validation Aspects

For a 'simple' self-contained testing system (no data exchange with For a 'simple' self-contained testing system (no data exchange with the 'outside world) the Ph21 can be operated as a 'GAMP the 'outside world) the Ph21 can be operated as a 'GAMP Category 3' system (see GAMP 5, Chapter 7 'Supplier Activities) Category 3' system (see GAMP 5, Chapter 7 'Supplier Activities) with reduced CSV activities.with reduced CSV activities.

However for a Ph21 system with data exchange GAMP Category 4 However for a Ph21 system with data exchange GAMP Category 4 will apply which means:will apply which means:

... 'Procedures to follow should be agreed between the regulated ... 'Procedures to follow should be agreed between the regulated company and the supplier and be documented in the appropriatecompany and the supplier and be documented in the appropriate

plan. Procedures adopted may be those of the regulated company or plan. Procedures adopted may be those of the regulated company or from the supplier QMS’...from the supplier QMS’...

Ph21 provides a ‘Quality documentation package’ with Ph21 provides a ‘Quality documentation package’ with comprehensive validation support also for the data exchange comprehensive validation support also for the data exchange procedures. These test suites often can be taken over by the user procedures. These test suites often can be taken over by the user of the system with no or little modification.of the system with no or little modification.

27



If Ph21 test systems shall be integrated data-wise into a If Ph21 test systems shall be integrated data-wise into a user/customer's IT infrastructure, prior consultation of the user/customer's IT infrastructure, prior consultation of the supplier (Ph21 specialists) and customer's IT/QC supplier (Ph21 specialists) and customer's IT/QC department is an essential prerequisite for a successful department is an essential prerequisite for a successful system implementation projectsystem implementation project

Electronic signatures of EBRs have to be validatedElectronic signatures of EBRs have to be validated

only trustworthy EBRses are good EBRsesonly trustworthy EBRses are good EBRses

28


Is there a 'cheap' way for EBRs?Is there a 'cheap' way for EBRs?

...often advertised by IT consulting firms:...often advertised by IT consulting firms:

digitally signed PDF filesdigitally signed PDF files• easy solution, signature interface already included in Adobe Acrobat©easy solution, signature interface already included in Adobe Acrobat©• receiver of EBR can easily check for authenticityreceiver of EBR can easily check for authenticity• disadvantage: numerical content cannot be queried (no data warehouse, no disadvantage: numerical content cannot be queried (no data warehouse, no

data mining)data mining)

scanned paper documents (TIFF and other picture files)scanned paper documents (TIFF and other picture files)• disadvantage: same as PDFdisadvantage: same as PDF

Data items which are not stored in some kind of database cannot be searched Data items which are not stored in some kind of database cannot be searched / analyzed later on. Therefore are useless for statistical process control / / analyzed later on. Therefore are useless for statistical process control / process improvement process improvement

29

*** The real benefit of EBRs ****** The real benefit of EBRs ***A repository of EBRs, collected over a longer period A repository of EBRs, collected over a longer period

of time (years) provides the opportunity to:of time (years) provides the opportunity to:

Run statistical trend analysisRun statistical trend analysis Use process capability parameters to assess the production Use process capability parameters to assess the production

processprocess Overall improve process performance and product quality using Overall improve process performance and product quality using

statistical analysis methodsstatistical analysis methods

The two most significant process capability parameters visualized

Cpk = 1 means 3 Sigma from mean to tolerance limit; 93.3% within limits1.33 4 Sigma from mean to tolerance limit; 99.4% within limits2.0 6 Sigma from mean to tolerance limit; 99,9997 % within limits

C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Cp.gif

C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Cpk.gif

30

The real benefits of EBRsThe real benefits of EBRs

Typical Questions being asked:Typical Questions being asked: What is the trend in batch runtime (1What is the trend in batch runtime (1stst test to last test of a batch) test to last test of a batch)

for product ‘A’ over the last half year?for product ‘A’ over the last half year? What is the trend in rejects for product ‘A’ over the last years?What is the trend in rejects for product ‘A’ over the last years? Why is weight deviation of product ‘A’ higher than product ‘B’?Why is weight deviation of product ‘A’ higher than product ‘B’? List all rejected batches where weight tolerance was violated by List all rejected batches where weight tolerance was violated by

less than 1%less than 1% Why are rejects lower when product ‘A’ is produced on press ‘X’ Why are rejects lower when product ‘A’ is produced on press ‘X’

then on press ‘Y’?then on press ‘Y’? Is there a trend for more rejects in the Summer months?Is there a trend for more rejects in the Summer months? Is there a higher reject rate during the night shifts?Is there a higher reject rate during the night shifts? Did improvement of machinery pay out in higher quality / better Did improvement of machinery pay out in higher quality / better

process capability?process capability?

Questions like this could be answered by running advanced statistical analysis Questions like this could be answered by running advanced statistical analysis on long-term collected electronic batch recordson long-term collected electronic batch records

Manual evaluation from paper files would be tedious to impossibleManual evaluation from paper files would be tedious to impossible

31

The real benefits of EBRsThe real benefits of EBRsPh21 provides some tools to accomplish this:Ph21 provides some tools to accomplish this:

Build-in summary batch statisticsBuild-in summary batch statistics External EBR evaluation program (also configured to customer’s External EBR evaluation program (also configured to customer’s

requirements)requirements) External statistics server for advanced statistical analysisExternal statistics server for advanced statistical analysis

Sample of Ph21 summary batch report

Sample using an external summary batch reporting tool

C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\batch_Summary.pdf

C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\External_Report.pdf

32

The real benefit of EBRsThe real benefit of EBRsPrintout samples of a statistical server (QS-Stat)Printout samples of a statistical server (QS-Stat) BoxplotBoxplot

• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Boxplot_01.bmpC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Boxplot_01.bmp

Capability BarchartsCapability Barcharts• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_BarchC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_Barch

art_01.bmpart_01.bmp

• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_BarchC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_Barchart_02.bmpart_02.bmp

Capability F-testCapability F-test• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_F-TesC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_F-Tes

t.bmpt.bmp

Capability PortofolioCapability Portofolio• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_PortofC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Capability_Portof

olio_01.bmpolio_01.bmp

Parts CharacteristicsParts Characteristics• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Parts_CharacteriC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Parts_Characteri

stics.bmpstics.bmp

Pearson CharacteristicsPearson Characteristics• C:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Pearson_CharactC:\Ph21q\Sidecar_Projects\Vortrag_EBR_Copenhagen_Jan-2011\illustrations\Pearson_Charact

eristics.bmperistics.bmp

33

The real benefit of EBRsThe real benefit of EBRs


If EBRs are collected and stored in a suitable format, the data If EBRs are collected and stored in a suitable format, the data records can be used for your/companies advantagerecords can be used for your/companies advantage

34

ConclusionsConclusions collecting EBR's instead of paper files makes collecting EBR's instead of paper files makes

good sensegood sense

long-term batch EBR evaluation can/will make long-term batch EBR evaluation can/will make sense if the right analysis tools are employedsense if the right analysis tools are employed

successful electronic batch record successful electronic batch record implementation requires attention from both implementation requires attention from both sides (user of the system and supplier of the sides (user of the system and supplier of the system /subsystems)system /subsystems)

thank you for your attention to this (partially) thank you for your attention to this (partially) 'dry' subject'dry' subject

whitepaper about a real world data exchange project to take away or for download at whitepaper about a real world data exchange project to take away or for download at www.ph21.comwww.ph21.com

35

Thank YouThank You

For your attention to this (partially) For your attention to this (partially) dry subjectdry subject

I wish a bon appetiteI wish a bon appetite

36

AcronymsAcronyms Manufacturing control & supervisionManufacturing control & supervision

• ERPERP Enterprise Resource ManagementEnterprise Resource Management• MESMES Manufacturing Execution SystemManufacturing Execution System• SCADASCADA Supervisory Control and Data AcquisitionSupervisory Control and Data Acquisition• PLCPLC Programmable Logic ControllerProgrammable Logic Controller• LIMSLIMS Laboratory Information Management SystemLaboratory Information Management System• PPCPPC Product Planning and ControlProduct Planning and Control• PATPAT Process analytical technology Process analytical technology

Encryption/digital Key StandardsEncryption/digital Key Standards• X.509X.509 is an standard for a public key infrastructure(PKI) is an standard for a public key infrastructure(PKI) • FDA ESGFDA ESG FDA Electronic Submissions GatewayFDA Electronic Submissions Gateway• DESDES Data Encryption Standard, 54 Bits (unsafe, withdrawn)Data Encryption Standard, 54 Bits (unsafe, withdrawn)• TDESTDES Triple DES, 168 Bits (improved DES, used by bank transfers)Triple DES, 168 Bits (improved DES, used by bank transfers)• AES (-128, -192 -256) Advanced Encryption Standard (current)AES (-128, -192 -256) Advanced Encryption Standard (current)

Internet data transport standardsInternet data transport standards• SSLSSL Secure Sockets Layer (outdated)Secure Sockets Layer (outdated)• TLSTLS Transport Layer Security (current)Transport Layer Security (current)

OtherOther• ESGESG FDA Electronic Submissions GatewayFDA Electronic Submissions Gateway• CSVCSV Computer Systems ValidationComputer Systems Validation• (M)PBR(M)PBR (Master) Production Batch Records(Master) Production Batch Records

37

Related linksRelated links FDA Electronic Submissions Gateway (ESG):FDA Electronic Submissions Gateway (ESG):

• http://www.accessdata.fda.gov/esg/userguide/webhelp/http://www.accessdata.fda.gov/esg/userguide/webhelp/ PAT:PAT:

• http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000162.jsp&murl=menus/document_listing/document_listing_000162.jsp&murl=menus/regulations/regulations/regulations.jsp&mid=WC0b01ac0580027089&jsenabled=trueregulations.jsp&mid=WC0b01ac0580027089&jsenabled=true

Full text of 21CFR-11:Full text of 21CFR-11:• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/

CFRSearch.cfm?CFRPart=11CFRSearch.cfm?CFRPart=11 DES encryption standard:DES encryption standard:

• http://csrc.nist.gov/publications/fips/fips46-3/fips46-3.pdfhttp://csrc.nist.gov/publications/fips/fips46-3/fips46-3.pdf AES encryption provider:AES encryption provider:

• http://www.aescrypt.com/http://www.aescrypt.com/ GAMP5 order source:GAMP5 order source:

• http://www.ispe.org/guidancedocs/operation_gxphttp://www.ispe.org/guidancedocs/operation_gxp Q-Das, Supplier of a statistic serverQ-Das, Supplier of a statistic server

• http://www.q-das.de/en/software/http://www.q-das.de/en/software/

© Ph21 Services Ltd, 2011

Electronic Batch Record Management (EBR management) Ph21 Services Ltd. In cooperation with Charles Ischi AG .

Documents

electronic batch records

batch recordsebrs

executed batch test

easy batch reviewprovides

comprehensive batch

related data

complete batch production

data mining