液相计算机系统验证报告

液相计算机系统验证报告 苏州万庆药业有限公司 QC-VAL-151-01 D-2000 Elite HPLC System Manager Qualification Report Validation NO:QC-VAL-151-01 Suzhou Homesun Wanqing Pharmaceutical Co., Ltd Oct, 2010 苏州万庆药业有限公司 QC-VAL-151-01 Report Confirmation Responsibility Department Name Signature Date QC Written by 李智达 QC Reviewed by 朱旭平 QC 王瑾 Audited by QA 王刚武 QA Approved by 彭志霞 1 苏州万庆药业有限公司 QC-VAL-151-01 TABLE OF CONTENTS 1. STATEMENT ????????????????????????????????????????????????????????????????????????????????????????????????????????????? 1 2. SCOPE ????????????????????????????????????????????????????????????????????????????????????????????????????????? 1 3. REFREENCE DOCUMENTS ??????????????????????????????????????????????????????????????????? 1 4. GLOSSARY ???????????????????????????????????????????????????????????????????????????????????????????????? 1 5. RESPONSIBILITIES ????????????????????????????????????????????????????????????????????????????????? 2 6. INSTALLATION QUALIFICATION (IQ) ??????????????????????????????????????????????? 3 7. OPERATION QUALIFICATION (OQ) ???????????????????????????????????????????????????? 7 8. PERFORMANCE QUALIFICATION (PQ) ??????????????????????????????????????????19 9. ATTACHMENT ???????????????????????????????????????????????????????????????????????????????????????29 2 苏州万庆药业有限公司 QC-VAL-151-01 1. Statement The objective of this protocol is to define the main requirements and processes for qualification of D-2000 Elite HPLC System Manager used in the laboratory analysis. D-2000 Elite HPLC System Manager is a chromatography data system supported by Hitachi used to control the Techcomp LC2000 HPLC instrument which also supported from Hitachi, the software can execute analyzer?s input automatically including establishing analytical method, executing method program, collecting sample response, acquiring data, reprocessing data and initiating electronic records. Techcomp LC2000 HPLC located in laboratories (including QC laboratory and in-process control laboratory), have been completed IQ, OQ, PQ test and approved for use. In order to prove that D-2000 Elite HPLC System Manager is appropriate for GMP requirements on laboratory computerized system, QC department will execute the qualification. 2. Scope This protocol applies to D-2000 Elite HPLC System Manager used to control Techcomp LC2000 HPLC. This protocol does not apply to LC2000 HPLC Qualification, it only contains applicable software (Chromatography Data System-Part Number890-8305) qualification. The instrument qualifications are performed according to QC-VAL-105-01. Chromatography Data System Qualification and HPLC Qualification constitute good operation and maintenance in HPLC application. 3. Reference Documents 3.1 GAMP Good Practice Guide: Validation of Laboratory Computerized Systems, 2005. 3.2 PDA technical report 31, „Validation and Qualification of Computerized Laboratory Data Acquisition Systems?, June 1999. 3.3 GMP Regulations (e.g. – 21 CFR 211.194, 91/356/EEC Ch 6, and ICH Q7A 6.6) 3.4 ICH Q7A – Good Manufacturing Practices for Active Pharmaceutical Ingredients, Chapter 5.4 Computerized Systems 4 Glossary 4.1 Computerized System: Computer system (hardware and software, including infrastructure) with associated functions and controlled process (equipment, users, procedures), in its operating environment 4.2 Data backup: Copy of the data on a different medium (for example floppy disk, cartridge, CD-Rom) to allow data retrieval in case of a failure of the main storage medium. 4.3 Data archival: Removal of some system data onto more durable and high capacity storage media (tapes, optical digital disks), necessary when the data is no longer required for routine work and data volumes are too great for the main storage medium. 4.4 Audit trail: An audit-trail is a computer -generated recording of changes to GMP records indicating who created or changed the data, when, and if needed, why. 第 1 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 4.5 Electronic Record (or Electronic Data): Combination of information in digital form that is maintained by a computerized system and used for a GMP regulated activity. 4.6 Applicable program: A document folder registered in D-2000 Elite HSM used to establish and storage analytical method, sample table, data and report. For example, create an applicable program , then authorized analyst could establish analytical method, sample table in this program, Moreover the analyst could use the method and sample table to initial origin data and report, 5 Responsibilities 5.1 System Administrator: To install the software per the user requirements, draft the validation protocol and implement the validation, maintain the system to correct errors. Complete the protocol and generate a paper report for review and approval. 5.2 QC management (QC supervisor or manager): To ensure that the system is in compliance with regulatory requirements and that the validation process is kept consistent with the protocol. 5.3 QA management (QA supervisor or manager: To ensure that documentation (including protocol and report) are consistent with applicable GMP regulations and to verify that the process comply with regulatory requirement. 第 2 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 6 Installation Qualification (IQ) Installation Qualification (IQ) must be performed to assure that the hardware and software components of the system are installed properly, and that the required documentation is available. 6.1 Inventory of supplier documentation Item Pieces Part No Part Name (Description) 1 1 890-5705 Hitachi Model D-2000 Elite HSM installation CD 2 1 890-5186 Software Validation certificate 3 1 890-9605 D-2000 Elite HSM Installation Manual 4 1 890-9611 Instruction Manual (For Administrator, Electronic Version) 5 1 890-9631 Instruction Manual (For User, Electronic Version) 6 1 890-9646 Before using D-2000 Elite HSM version 2.0 Remark: All documentation will be archived in QC document room and any electronic version will be backed up on different medium. Checker/Date:_____________________ Reviewer/Date:__________________________ 6.2 Verification of hardware configuration Hardware Lowest Configuration Verification CPU Pentium 4 microprocessor, 2G Hz Celeron(R), 1.8GHz Memory 512MB 1G Display Monitor 1024×768 pixels 1280×960 pixels Hard disk 2GB 250G CD-ROM drive At least one CD-ROM drive one CD-ROM drive USB port At least one USB port five USB ports RS-232C port At least one RS-232C port one RS-232C port Mouse Compatible with Windows XP conforms Printer Compatible with Windows XP conforms Checker/Date:_____________________ Reviewer/Date:__________________________ 6.3 Verification of sensors For controlling the HPLC instrument from the PC, it is required to provide the USB interface board (IFB) and install the IFB driver software. Install the Analog Input Device (AID) and connect it with PC and HPLC per the following figure: 第 3 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 Installation Verification(Yes/No) AID was installed onto the autosampler correctly Yes IFB was installed onto the pump correctly Yes PC was connected with IFB correctly Yes AID was connected with detector correctly Yes e-line connector was connected with IFB and AID correctly Yes Pump and autosampler were connected correctly Yes Checker/Date:_____________________ Reviewer/Date:__________________________ 6.4 Verification of instruments Make sure HPLC has been performed with IQ, OQ, PQ. Qualification meets the acceptance criteria, all instruments being used within the expiry dates. Instrument NO Qualification Document NO Meet acceptance criteria(Yes/No) Expiry Date S-08-H-11171 QC-VAL-105-01 Yes 2011.03.25 Checker/Date:_____________________ Reviewer/Date:__________________________ 第 4 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 6.5 Verification of software version Item D-2000 Elite Requirement Verification Operating System Microsoft Windows XP Professional Microsoft Windows XP Professional Standard File System NTFS NTFS NTFS: A senior file system that provides performance, safety, reliability and advanced characteristics. It keeps the consistency of the roll by standard affairs log function and its recovery technology. In Windows 2000 and Windows XP, NTFS can also offer advanced features such as documents and folders permissions, encryption, disk quota and compression. Checker/Date:_____________________ Reviewer/Date:__________________________ 6.6 Verification of software installation procedure Execute D-2000 Elite HSM (HPLC System Manager) installation according to D-2000 Elite HSM Installation Manual, record the whole process to assure main sequence and detailed operation of installation maintaining consistency with vendor requirement. Step Description Verification 1 Installation of D-2000 Elite HSM in the Windows XP Yes 2 Mounting of IFB on the HPLC module unit Yes 3 Installation of IFB driver in the windows XP Yes Checker/Date:_____________________ Reviewer/Date:__________________________ 6.7 Recording the software configuration Software Configuration 1 Set analysis method parameter 2 Data acquisition 3 Chromatography data process 4 Initialize analysis report 5 Documentation management 6 Module operation Checker/Date:_____________________ Reviewer/Date:__________________________ 6.8 Verify the configuration of backup systems Backup systems Description USB There must be a procedure available describing USB should be formatted before backup to avoid virus contamination and damage to operation system and original data. Checker/Date:_____________________ Reviewer/Date:__________________________ 第 5 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 6.9 IQ should be completed and approved for systems prior to commencing the OQ. Any deviation should be recorded. A Summary Table is created confirming that the IQ was performed according to plan and/or explaining any deviations observe and their resolution or follow-up actions. IQ Summary Table IQ items verification deviation 1 Inventory of supplier documentation Yes None 2 Verification of hardware configuration Yes None 3 Verification of sensors Yes None 4 Verification of instruments Yes None 5 Verification of software version Yes None 6 Verification of software installation procedure Yes None 7 Recording the software configuration Yes None 8 Verify the configuration of backup systems Yes None Deviation description: None Deviation resolution or follow-up action: None IQ Conclusion: IQ is completed prior to OQ, no deviation is observed. IQ test has been passed and approved. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 6 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7 Operation Qualification (OQ) Operational Qualification (OQ) must be performed by User Representatives to assure testing of the system functions. OQ must focus on the GMP related function(s) of the system. 7.1 Testing access control Make sure that access control is existed, anyone needed to access D-2000 Elite HSM should be authorized with a user name. One can not access the system without system administrator?s authorization. Content Verification Access control is existed. Yes Personnel with user name could access the system. Yes Personnel without user name could not access the system. Yes Checker/Date:_____________________ Reviewer/Date:__________________________ 7.2 Testing rules on passwords Establish 6 simulated users named A, B, C, D, E, F and give them corresponding password “A1234”, “B2345”, “C3456”, “D4567”, “E5678”, “F6789” respectively. Use everyone?s own password and others? passwords to test the validity of password. If the user with the right password could access the system, sign “Y”; if the user without the right password couldn?t access the system, sign “N”. User password access User password access User password access A1234 Y A1234 N A1234 N B2345 N B2345 Y B2345 N C3456 N C3456 N C3456 Y A B C D4567 N D4567 N D4567 N E5678 N E5678 N E5678 N F6789 N F6789 N F6789 N User password access User password access User password access A1234 N A1234 N A1234 N B2345 N B2345 N B2345 N C3456 N C3456 N C3456 N D E F D4567 Y D4567 N D4567 N E5678 N E5678 Y E5678 N F6789 N F6789 N F6789 Y Checker/Date:_____________________ Reviewer/Date:__________________________ 7.3 Testing the defined user profiles “D-2000 Elite Group Security Protection” Function has defined 3 groups for D-2000 Elite users with different levels. The function runs bind to Function, D-2000 user groups are created by Windows XP Administrator. Grades User Group Name 1 D-2000 Administrator 2 D-2000 Developers 3 D-2000 Operators Checker/Date:_____________________ Reviewer/Date:__________________________ 第 7 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 Use “Print Screen SysRq” button on the keyboard to paste the interface Checker/Date:_____________________ Reviewer/Date:__________________________ 7.4 Testing the analytical method management functions D-2000 Elite HSM could create a new analytical method in applicable program. In order to validate that the software could correctly execute the analyst?s setup. The checker will create a simulated analytical method in D-2000 Elite HSM, record the setup process and the related response. Document the execution procedure by pasting image in sequence to prove the validity for the analytical method setup process. 7.4.1 Open Menu“File”, select “New” . Pasted By/Date_______________________ Reviewer/Date:________________________ 第 8 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.2 Select “Method” then select “enter” Pasted By/Date_______________________ Reviewer/Date:________________________ 7.4.3 The “Method” interface appears. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 9 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.4 Press, then set Remark: In this step, the user could select each part of the instrument from the list, including detector, column oven, auto-sampler, and pump, the link connects PC and the instrument. D-2000 Elite will recognize the pre-existing components after running the HPLC and implement the control to each part. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 10 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.5 Press, set Remark: In this step, the user could fill in “method name”, “author”, “description”, “mobile phase” to define the method. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 11 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.6 Press, set Remark: In this step, the user could set “pump upper limit”, “pump lower limit”, “time”, “flow”, “gradient mobile phase”, and fill in “mobile phase name” for method traceability or R&D use. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 12 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.7 Press, set Remark: In this step, the user could set “injection speed”, “needle speed”, “injection volume”, “number of rinse”, “rinse speed”, “needle wash time”, etc. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 13 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.8 Press, set Remark: In this step, the user could set “column oven temperature”, “temperature upper limit”, “column temperature confirmation before sampling”. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 14 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.4.9 Press, set Remark: In this step, the user could set “wavelength”, “data acquisition distribution at different times with different wavelengths”, “data acquisition time ”, “detector response time”, “absorbance range”, “drift”, “auto-zero before data collection”, and “interval time for acquisition after sampling”, etc. Pasted By/Date_______________________ Reviewer/Date:________________________ 7.4.10 A new analytical method has been created in OQ test. It demonstrates that the user could create a method in applicable program, an existed analytical method could also been changed and saved in this function. Only administrator and developers with the access control authorization can change analytical method, users whom need to create and change the method should be authorized and trained. The rights of different users to change “analytical method” will be verified in PQ of Section 8.1. 第 15 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.5 Testing the sample table management functions D-2000 Elite HSM could create a new sample table in applicable program. In order to validate the software could correctly execute the analyst?s setup. The checker will create a simulated sample table in D-2000 Elite HSM, record the setup process and the related response. Document the execution procedure by pasting image in sequence to prove the validity for the sample table setup process. 7.5.1 Press to create a new sample table, the sample table appears as follows, Remark: The image above is a “single sample setup”. In this step, the user could setup “single sample”, fill in “method to be used”, “standard sample name”, “test sample”, “numbers of injection”, “injection volume”, “sample vial No.” as necessary. Pasted By/Date_______________________ Reviewer/Date:________________________ 第 16 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.5.2 Press to create a “sample sequence setup”, the button is beside the button. Remark: In this step, the user could setup a “sample sequence”, fill in “sample vial No.”, “injection volume”, “number of injection”, “sample type” (select standard sample or test sample as necessary), “method to be used” etc. Pasted By/Date_______________________ Reviewer/Date:________________________ 7.5.3 A new sample table has been created in OQ test. It demonstrates that the user could create a sample table in applicable program, an existed sample table could also been changed and saved in this function. Only administrator and developers with the access control authorization can edit sample table, users whom need to create, change and delete the sample table should be authorized and trained. The rights of different users to edit “sample table” will be verified in PQ of section 8.1. 第 17 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 7.6 OQ should be completed and approved for systems prior to commencing the PQ. Any deviation should be recorded. A Summary Table is created confirming that the OQ was performed according to plan and/or explaining any deviations observed and their resolution or follow-up actions. OQ Summary Table OQ items verification deviation 1 Testing access control Yes None 2 Testing rules on passwords Yes None 3 Testing the defined user profiles Yes None 4 Testing the analytical method management functions Yes None 5 Testing the sample table management functions Yes None Deviation description: None Deviation resolution or follow-up action: None OQ Conclusion: OQ is completed prior to PQ, no deviation is observed. OQ test has been passed and approved. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 18 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8 Performance Qualification (PQ) Performance Qualification (PQ) must be performed by instrument users to verify the performance of the system. This activity may be performed in actual environment. PQ must focus on the GMP related steps of the supported process. 8.1 Verification of authorized users and their corresponding rights After installation of D-2000 Elite HSM in windows, three levels of applicable individuals with different rights were authorized to ensure laboratory data security. In OQ test (section7.2), The users “A”, “B”, “C”, “D”, “E”, “F” were simulated set up. Define “A”, “D” as administrator, “B”, “E” as developer, “C”, “F” as operator to test the rights with different grades. Record the results in the following chart. Administrator Developers Operators D-2000 administration , Create/delete applicable program Yes No No , User authorization , Set GLP option D-2000 HSM(HPLC system manager) Analytical Method , Create Yes Yes No , Change and save , Delete D-2000 HSM(HPLC system manager) Sample Table , Create Yes Yes Yes , Change and save Yes Yes Yes , Delete Yes Yes No D-2000 HSM(HPLC system manager) , Data Acquisition Yes Yes Yes , Data Reprocess Yes Yes Yes , Data Report Yes Yes Yes Data management , Data name change Yes Yes Yes , Data Backup Yes Yes No , Delete Data No No No Checker/Date:_____________________ Reviewer/Date:_______________________ 8.2 Testing of sample and analytical method preparation The sample and recommended method are supplied by instrument vendor. Sample: Methylparaben Standard Solution Recommended method: 1. Mobile Phase: Methyl Alcohol: Water (60: 40) 2. Column: C18, 4.6×250mm, 5um 3. Wavelength: 254nm 4. Flow: 1.0ml/min 5. Injection volume: 5,l Checker/Date:_____________________ Reviewer/Date:_______________________ 第 19 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.3 Testing of data acquisition Place sample (prepared in Section 8.2) in sample rack, prime the column to allow the chromatographic system to be stabilized, then press to start sample injection and data acquisition. Paste the observed data acquisition image to demonstrate that the system could execute D-2000 Elite HSM well. No error or deviation occurs. Remark: Data acquisition during sample analysis. D-2000 Elite HSM works well. Checker/Date:_____________________ Reviewer/Date:_______________________ Record the states of detector, auto-sampler and pump by pasting the images shown below. Remark: Detector state image. The detector works well. Observe the screen on detector panel, it shows 254nm. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 20 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 Remark: Auto-sampler state image. The auto-sampler works well. Observe the screen on auto-sampler panel, it shows injection volume is 5 ,l. The vial No. is consistent with actual vial location set by the operator. Checker/Date:_____________________ Reviewer/Date:_______________________ Remark: Pump state image. The pump works well. Observe the screen on pump panel, it shows flow rate is 1.0ml/min. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 21 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.4 Testing that an operator can not delete raw data. After the raw data is created by D-2000 Elite HSM, perform the challenge to delete raw data. Paste the image to document the process and result. Remark: Open the file and select the raw data “0002” to perform the challenge test. Checker/Date:_____________________ Reviewer/Date:_______________________ Press to delete raw data “0002”. Remark: The image shows that D-2000 Elite HSM rejects to delete the raw data. It proves the integrity of D-2000 Elite HSM by showing that the system will not allow any user to delete raw data. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 22 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.5 Testing the full traceability of performed analytical methods (audit trail). Change the analytical method and save the updated method. Paste the images to document the process and result. Remark: Change the parameter of the analytical method, and save the updated method. D-2000 Elite requires the user to fill in the column for remarks. Checker/Date:_____________________ Reviewer/Date:_______________________ Remark: Open the method file again, the log of activity is created. It shows the “date and time of change”, “user name”, and “remarks”. The image demonstrates that a traceability log would be created in D-2000 Elite HSM once the change is made to the method. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 23 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.6 Testing the full traceability of data creation and reprocessing (audit trail). Select a raw data and reprocess the data, Paste the images to document the result. Remark: Open the report file, the images shows that raw data labeled as “original”, reprocessed data labeled as “modified”, reported data labeled with a defined report name. D-2000 Elite also creates the traceability log for time of change. Raw data show its “creation time”, reprocessed data show its “modified time”, Test report file not only show its “report name”, but also show its “report issued time”. D-2000 Elite HSM could only use the report printout to output any test data. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 24 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.7 Testing or documenting the traceability of equipment used (audit trail). Paste the images to document the traceability information. Remark: Open the data file, the image shows the traceability information “the equipment used”, “the method used”, “date and time”. The information keeps integrity for laboratory raw data. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 25 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.8 Testing data backup and retrieval Backup data into another medium and perform the data retrieval. Paste the images to document the process and results. Press to backup the applicable program into a prepared USB. Checker/Date:_____________________ Reviewer/Date:_______________________ Remark: Open the USB, the applicable program has been backuped into USB successfully. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 26 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 Copy the applicable program “Qualification” from USB to the location previously saved on the hard disk. Paste the images to document the retrieval result. Remark: Open the data file, the raw data has been recovered successfully. Checker/Date:_____________________ Reviewer/Date:_______________________ 8.9 Testing of results printout and comparison of the printout with the screen image. See Attachment (Section 9). The printout keeps consistent with screen image. Checker/Date:_____________________ Reviewer/Date:_______________________ 8.10 Testing that all critical parameters and data that can influence the result are printed out. See Attachment (Section 9), all critical parameters and data that can influence the result are printed out. Checker/Date:_____________________ Reviewer/Date:_______________________ 8.11 Testing that the system will not allow any user to alter data in print and thus to print erroneous results. See Attachment (Section 9), the system will not allow any user to alter data in print and thus to print erroneous results. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 27 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.12 Manual re-calculation of automated results Manually measure the T and W, then calculate the theoretical plates. The manual h/2 calculated results are compared to that generated by D-2000 Elite HSM. The number of theoretical plates, N, is a measure of column efficiency, it is calculated by equation: 2,,T,, N,5.54,,Wh,/2, Where T is the retention time of the substance and W is the width of the peak at its half h/2 height. Measure T and W in attachment (Section 9), T is 34.2mm, W is 0.7mm, calculate the h/2 theoretical plates, the result is 13,224. Manual Calculation 13,224 USP 13,148 D-2000 Elite HSM calculation EP 13,279 JP 13,303 Remark: The manual calculated result is comparable to that generated automatically by D-2000 Elite HSM, indicating that D-2000 Elite could obtain accurate result. Checker/Date:_____________________ Reviewer/Date:_______________________ 第 28 页 共 29 页 苏州万庆药业有限公司 QC-VAL-151-01 8.13 The PQ in combination with OQ confirms that the mandatory GMP user requirements specifications are satisfactorily met. Other requirements may be met by system functionality or other means such as procedurally. Functionality of a lesser importance may not be included, or deferred to a later time. A PQ Summary Table is created here confirming that the PQ is performed according to plan, no deviations are observed. PQ Summary Table PQ items verification deviation 1 Verification of authorized users and associated rights Yes None 2 Testing of sample and analytical method preparation Yes None 3 Testing of data acquisition Yes None 4 Testing that an operator can not delete origin data Yes None Testing the full traceability of performed analytical methods (audit 5 Yes None trail) Testing the full traceability of data creation and reprocessing (audit 6 Yes None trail) Testing or documenting the traceability of equipment used (audit 7 Yes None trail) 8 Testing data backup and retrieval Yes None 9 Testing of results printout Yes None Testing that all critical parameters and data that can influence the 10 Yes None result are printed out Testing that it is impossible to alter data in print and thus to print 11 Yes None erroneous results 12 Manual re-calculation of automated results Yes None Deviation description: None Deviation resolution: None PQ Conclusion: D-2000 Elite HSM is successfully qualified per IQ/OQ/PQ protocol QC-VAL-151-01, the system is able to meet the applicable GMP requirements. D-2000 Elite is reliable and satisfied for use. Checker/Date:_____________________ Reviewer/Date:_______________________ 9 Attachment 第 29 页 共 29 页