Does the software need to do 3Q certification? What instruments need to be certified by 3Q?

You're talking about 3C certification.

Well, this only regulates the hardware and not the software, so the software doesn't need to do it.

CCC is China's compulsory electronic product testing and certification requirements mark, no matter what product is mainly controlled EMC and safety two parts of the test.

The signs are as follows: <>

China CCC certification mark.

The world's largest number of such testing and certification institutions are in China, and the most concentrated testing and certification institutions in China are in Guangdong.

Guangdong's most active and most selectable institutions are in Shenzhen, with the best service, cycle and reasonableness.

Just find a reliable Shenzhen service agency and say what product you need to sell or what you want to test.

Don't know what area of software you're asking?

If it is a laboratory, the hardware involved is liquid chromatography, gas chromatograph, etc., and various analytical instruments. Then the corresponding software 3Q certification is the quality system certification IQ (installation verification), OQ (operation verification), PQ (performance verification), it is recommended to contact the original software manufacturer to provide services, more professional and safe.

For example, if your laboratory has installed laboratory cryopreservation sample management software, or LIMS pharmaceutical laboratory software information management collaboration platform, you can contact the original manufacturer of the software to provide the corresponding 3Q certification service. The meaning and value lies in:

It can provide laboratory computerized system verification and assist enterprises (pharmaceutical companies) to establish a complete computerized system verification system. Responsible for verifying compliance with regulatory compliance and compliance with relevant documents and records. Responsible for the preparation and implementation of the verification plan report.

The original manufacturer of the freezerpro biobanking software that we purchased was able to provide the above services and provide paper reports and materials.

For example, liquid chromatograph, gas chromatograph, etc., various analytical instruments.

3Q certification: 3Q certification is quality system certification IQ (installation verification), OQ (operation verification), PQ (performance verification).

3Q certification for stability test chambers.

Through a series of activities such as DQ (Design Confirmation), FAT (Manufacturing Plant Test), IQ (Installation Confirmation), OQ (Operation Confirmation), PQ (Performance Confirmation), etc., the data and conclusions provided can prove that the equipment can meet the needs of the production process in production, and the performance of the equipment meets the design requirements, product factory standards and national GMP requirements.

DQ confirmation purpose: according to customer demand standards and production technology, review the performance, material, structure, accessories, control, instrument and other aspects of the equipment against the contract configuration and design drawings, and verify the rationality and reliability of the product in the design process.

The purpose of FAT confirmation: to prove the reliability of the product quality of the equipment before packing and leaving the factory through a series of experimental tests in the manufacturing factory, and to prove that the equipment can meet the basic requirements of design confirmation, product factory standards and national GMP requirements.

The purpose of IQ confirmation: to provide a series of test data through on-site installation, commissioning, and verification activities to prove that the installation documents and installation conditions of the drug stability test chamber meet the design requirements, and the data and documents meet the requirements of GMP management.

The purpose of OQ confirmation: firstly, check the inspection report of the instrument provided by the verifier, check and test the operating technical parameters of the equipment, and confirm that the operating performance of the stability test chamber meets the design requirements and meets the relevant requirements of GMP.

The purpose of PQ confirmation: on the basis of installation confirmation and operation confirmation, according to the specific production process of the manufacturer, add similar test products for testing, and confirm that the operation performance of the equipment meets the design requirements and meets the relevant requirements of GMP.

Instruments for analysis such as liquid chromatography, gas chromatographs.

The 3Q certification of instruments in the pharmaceutical industry refers to:

IQ, Installation Qualification, confirms the instrument documentation, components, and installation process.

OQ, Operational Qualification, confirms that the instrument can operate normally within the operating limits in the idling state.

PQ, Performance Qualification, confirms whether the instrument meets the standard requirements under sample loading operation.

3Q Certification Practices:

1. IQ (Installation Confirmation):

As the name suggests, it is the confirmation (or validation) of the installation process of the instrument.

The first is the preparation of paper documents, which can be listed in the form of **, including the instrument manufacturer's certification materials such as instrument materials and testing; Instrument manufacturer's manual, packing list, accessories list and other information; Use the standard operating procedures, maintenance records, use records, personnel training and other documents prepared by the department; Proof of calibration of gauges or other components, etc.

The second is the confirmation of the preparation of the external environment, such as room exhaust, temperature and humidity control; Electricity**, emergency measures for unexpected power outages, etc.

Finally, the confirmation of the parts of the instrument itself, according to the manual and the characteristics of the instrument itself, check whether the above preparations are completed and reasonable.

2. OQ (Operation Confirmation):

It is mainly to verify that the instrument can complete good operation within the limit direction of the instrument design in the case of idling, that is, the verification of a minimum and maximum limit test. A number of metrology devices are used here to confirm some of the functions of the instrument.

For example, we need to use an external temperature device to verify whether the maximum and minimum temperature of the instrument itself are within the design range. For example, if the injection volume is large, you can use a calibrated gage to confirm it; If the volume is small, it needs to be confirmed by indirect methods, such as the injection accuracy of the liquid phase, which can be confirmed by continuous injection of the standard sample.

3. PQ (Performance Confirmation):

For the instrument, this step can be simply understood as the OQ (Running Confirmation) of the actual sample, because this step is to bring in the sample for testing, and there is a sample of known concentration to verify the accuracy of the instrument; There are samples of unknown concentrations to verify the instrument's detection capabilities, etc. To put it simply, it is the process of testing once or twice according to the method of sample testing. Generally speaking, if the IQ (Installation Qualification) and OQ (Operation Qualification) are done, the PQ (Performance Qualification) will be successfully passed.

Approximately 5%-15% of the instrument itself is purchased for the purchase of a full set of validation data).

There is a slight difference between the organic acid ions and the molecular capacity factor using RPHPLC, which is usually manifested by the presence of too many ionotypes due to insufficient buffer capacity or improper pH adjustment, resulting in broadening or even bifurcation of peaks. But your question is not here, the key is what to use as a solvent to ensure that the ratio of organic acids to its sodium salt remains unchanged before and after the sample is dissolved?

Don't believe him, block him. Just call the person who pays the money, be careful.

Necessarily not credible. Job hunting should be cautious and cautious if you have to pay money first, and generally regular enterprises do not do this. Best wishes.

Hello! Kiss! Don't believe it!!

We have a number of senior engineers in system service, all of whom have received FDA GLP theoretical training and have accumulated rich practical experience in long-term work. Our engineers have been providing services for high-standard GLP laboratories for a long time, undertaking and responsible for the quality engineering of software and hardware in the laboratory, including the verification and maintenance of various instruments and software, and establishing a complete GLP laboratory quality framework system for the laboratory. Our engineers are involved in the whole process of various software and hardware from the drafting of quality verification plans to the actual operation, and all kinds of verification projects have been audited by the quality assurance personnel of Novartis, Eli Lilly, Merck and other major companies, which can well meet the requirements of enterprise quality assurance personnel.

Our services include:

Provide user requirements (URS) documents;

Provision of Functional Standards (FS) documents;

Provide design qualification (DQ) services and documentation;

Provide installation qualification (IQ) services and documentation;

Operational Qualification (OQ) services and documentation;

Performance Qualification (PQ) services and documentation;

Provision of Standard Operating Procedures (SOPs);

Provision of Business Continuity Plan (BCP);

Provide software validation CSV (computerized system valdiation) services;

Provide GLP, GMP verification training and consulting services, etc.

Install the verification IQ

Operational Validation OQ

Performance Verification PQ

A chemical instrument in a pharmaceutical factory needs 3Q certification, what are IQ, OQ, PQ? Installation Verification IQ, Operational Verification OQ, and Performance Verification PQ