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GxP Assessment & Categorization of Computerized System

***Data Integrity App for Pharma compliance***

In Earlier post we understand what steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed.

Now in this article we are going to understand GxP Assessment & Categorization of Computerized System. It is first stage of whether a system requires a validation is to identify whether the system has a GxP impact.

The result of the GxP Assessment and system Category checklist decided whether Validation required for computerized system.

If Outcome is “GxP Applicable” then follow Computer system validation procedure and other risk assessment for validating the system.

All systems which handle data or processes which fall under the impact of GxP or any other regulatory requirements must be validated

Determine whether the application has been validated elsewhere you in organization. The amount of work required may be significantly reduced by referring some of the deliverables in as in state or with slight changes. The details must be addressed in the change control.

If required any “Non GxP Applicable “systems that process data critical to operations of the business such as those involving financial, certain personal data etc.

Quality assurance, IT, CSV responsibility person, HOD of User department may consider the validation of such systems as a part of good business practice.

GxP Assessment of computerized system:

GxP Assessment determines whether a system requires a validation to identify whether the system has a GxP impact.

Perform GxP assessment using below Questioners:

Is the system used to generate data used in support of a regulatory submission?
Is the system is used to monitor, control or supervise a GxP manufacturing or packaging process and have the potential to affect Product Quality, Safety, Identity or Efficacy?
Is the system used to hold and/or manipulate clinical study data?
Is the system used to monitor, control or supervise packaging and labeling operations?
Is system used to create critical study control data?
Does the system hold electronic records that are or could be used in electronic form to make GxP decisions?
Is the system used to transmit e-data/ records to other systems for the execution of GxP activities?
Is the system is used for GxP analytical quality control?
The system manipulates data, or produces reports, to be used by GxP quality related decision authorization / approval processes, where the data supports the decision process or the electronic record constitutes the master record.
Is the system is used to maintain compliance with a GxP requirement?
Is the system is used to monitor, control or supervise warehouse or distribution within a GxP requirement?
Is the system is used for GxP batch sentencing or batch records?
Is the system used to store GxP documents for example SOPs, Specifications, BMR, BPR,DMF
Is the system used for GxP data backup, restore, archival or storage, data security or access / domain control?
Is the system used for physical access to GxP to the environment (i.e. area or location)?
Does the system support a GxP application i.e. LAN/WAN?

If any of the above questions are answered “Yes” then the system has a GxP impact and the system requires a level of Validation and control through the Computer Systems Validation.

If all the questions are answered “No” then the system may be deemed not to have a GxP Impact. This should be documented to support the decision not to perform formal validation. .

System Categorization:

Refer below checklist shall be used to classify the systems into one of the System Categories

Is the system established commercially and is used to run other programs/applications?
Does the system consist of software which is not directly useful for business purposes but makes the computer hardware useful? An example is the Windows Operating System?
Is the system used to perform basic tasks, such as recognizing input from the keyboard, sending output to the display screen, keeping track of files and directories on the disk, and controlling peripheral devices such as disk drives and printers?
Is the system available as a ready-made product for sale to the general public?
Can the system be implemented without performing any customization or configuration to it (i.e. system will be used “As-Is”)?
Can the system be configured for use for a specific function without altering the basic program? In other words, can the system be tailored to meet your business requirements/needs?
Does the system consist of a program or group of programs specially designed for the end users?

Based on above mentioned question Application software falls into one of the categories as –

Category 1: Operating System

[Note: If the answer to question 1 to 3 is Yes, then this category is applicable]

2. Category 3: Standard Software Packages (Commercial Off the Shelf (COTS) As-Is)

[Note: If the answer to question 4 and 5 is Yes, then this category is applicable]

3. Category 4: Configurable Software Packages (Configurable COTS)

[Note: If the answer to question 4 and 6 is Yes, then this category is applicable]

4. Category 5: Custom (Bespoke) Software

[Note: If the answer to question 7 is Yes, then this category is applicable.]

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We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

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Steps should be executed for performing Computer System Validation

In Earlier post we understand what is Computer System Validation (CSV), Why CSV Required, Purpose of CSV & Benefits of CSV.

Now in this article we are going to understand steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed.

Each & every steps having its own importance. So, Never miss any steps while performing validation activity.

Steps which never missed in computer system validation.

1	GxP Assessment & System Categorization
2	System Level Risk Assessment
3	User Requirement Specifications (URS)
4	Functional Specifications (FS)
5	Design Specification (DS)
6	Project Validation Plan (PVP)
7	Configuration Specification (CS)
8	Requirement Traceability Matrix (RTM)
9	Software Code Review
10	Qualification Protocol (IQ/OQ/PQ/IFQP)
11	Generate Test Script
12	Qualification Report (IQ/OQ/PQ/IFQP)
13	Discrepancy Form (DS)
14	Discrepancy Log ( DL)
15	Validation Summary Report (VSR)
16	System Release Certificate (SRC)
17	Signature Log (SIL)
18	GAP Assessment
19	Screen Print Attachment
20	Validation Document Log (VDL)
21	Validation Master Plan
22	System Deliverable Matrix
23	Impact Assessment
24	CSV Document Preparation, Review & Approval Matrix
25	Project Change Management Form
26	Project Change Management Log

All these above steps are need to be performed during successful computer system validation. Let’s break down each part a little bit further in next article.

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Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

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What is CSV, Its Need, Purpose & Benefits in pharma Industry.

History of CSV:

The concept of validation was derived from engineering principles of validation of mechanical system that has been extended to the software industry.

To extend it further during mid-1970’s, Ted Byers and Bud Loftus, two Food and Drug Administration (FDA) officials first proposed the concept of validation in order to improve the quality of pharmaceuticals (Agalloco 1995).

In 1987 the FDA published a document entitled ‘FDA Guidelines on General Principles of Process Validation’.

It state that

Feeling the necessity of Validation, FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the ‘bluebook’ (FDA 1983).

For MHRA this is Annex 11 of the EU GMP regulations (EMEA 1998), whereas for American FDA, this is 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997).

What is CSV?

According to both American FDA and UK MHRA, Computer System Validation is defined as

A computerized system includes: the computer hardware, computer software, peripheral devices, personnel, and computer system documentation (including computer hardware and software manuals, specifications for peripheral devices and standard operating procedures).

The computerized system used to control critical functions in food processing should be validated in its entirety.

CSV is a documented process for assuring that a computer system does what it is designed to do.

Validation of computer systems is not a onetime event it periodic activity. CSV should be performed by person other than those responsible for building system.

Purpose of CSV:

The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product (control information or data) which meets predetermined specifications and quality attributes.

Computer System Validation is more than a way to avoid profit loss and business risks. In certain instances, it can be life-saving.

Why CSV:

FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.

Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.

CSV becomes important as the FDA requires all computerized systems with GxP electronic records to be validated.

All computerized systems that have an impact on product quality, patient safety and data integrity need to be validated.

CSV Need to:

To ensure use of system is safe for quality of the product & health of the patients
Get confidence in Data produced by the system
Compliance with regulations
Assure “Inspection Readiness”
Avoid negative publicity

If you failure to take corrective action in a timely manner can result in shutting down manufacturing facilities, consent decrees & stiff financial penalties.

Benefits of CSV:

Legal compliance with the FDA: After completing Computer System Validation, companies will be able to provide regulatory organs with all the needed documentation
Reduces compliance risks. Having empirical evidence of the fact that the system works as expected comes in handy during the inspections from regulatory organs.
Discovers defects before a system build goes live. This way, pharmaceutical companies can avoid image losses or fraud.
Provides companies with continuous improvement. Validation is a necessity for companies that constantly scale and add new features as it allows the development team to prevent tech debt from piling up.
Maximizes system efficiency. If companies have validated systems, a business manager increases its future value and the efficiency of employers that use it. In the long run, CSV reduces both operating and labor costs.

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Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

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What is Whistle-blowing? It will save you or your Company or Public?

Whistle-blowing:

The pharmaceutical industry is huge, Worldwide and more closer to home.

India is also one of the largest exporters of medicines to the United States. Medicines are highly regulated for expected reasons.

Over the last few years, corporate India has seen the rise of a new kind of crusader – the whistle-blower.

These champions have tried to uncover many scams related to Violation of laws, various data integrity issues & fraud activity.

Whistleblowing is a term that describes people who become aware of activities within an organization or entity that are legally questionable.

The FDA has believed that whistle blowing among employees & former employees is a critical way of maintaining compliance & corporate data integrity.

Whistle Blowers Types:

Internal Whistle Blower: The whistle blower has a connection to the organization. This could be an employee, an officer, or a shareholder.
External Whistle Blower: External whistle blowers reveal the activity to someone outside the company. That entity may be a law enforcement agency that has jurisdiction

Law that protect Whistle blowers:

In the United States the False Claims Act encourages whistle-blowing by private individuals to expose evidence of fraud.

They are rewarded for their efforts with monetary compensation and protection from retaliation.

The FCA also contains an anti-retaliation provision which protects an employee from being “discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms & conditions of employment by his or her employer”

A former employee of a global pharma giant, received a $96-million settlement after suing her former employer under the False Claims Act (FCA).

Her initial whistle blowing case dealt with various data integrity issues as well dangerous slip ups such as product mix ups, missing validations & SOP’s in need of revision.

What was most shocking was that the company did not appeal & this became the first ever pharmaceutical whistle blowing lawsuit to invoke cGMP’s & succeed.

Reason of whistle-blowing

Failure to Comply with cGMPs Misrepresenting the safety & efficacy of drugs to federal regulators
Off-label Marketing: The law prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved.
Kickbacks: The law prohibits drug companies from offering or paying any remuneration, in cash or kind, directly or indirectly, to induce physicians or others to order or recommend drugs that may be paid for by a federal healthcare program.
Upcoding: Providers may not prescribe more of a drug than is medically necessary or for uses other than those approved by the FDA.
Ghost-Writing & Seeding Trials: companies draft medical papers promoting off-label uses of drugs & pay doctors to insert their names as authors of the documents
Overcharging federal healthcare programs for drugs

How to avoid whistle-blowing?

To promote a zero tolerance approach towards malpractice,
Begin at grass roots level with the behavioral change of staff
Staff should be encouraged to report irregularities without fear
Staff should be trained in corporate policy & implementation.
Maintain proper internal control
Set effective communication between management & staff

Steps to a Successful Whistleblower Claim:

Contact a Pharmaceutical Whistleblower
Determine Whether A False Claim Exists
Don’t Talk to Anyone Except Your Lawyer
Gather Evidence Legally and Confidentially
Draft and File Your Whistleblower Claim
Assist with the Investigation
Prepare for Potential Retaliation
Have Check in Hand Before Spending the Money

Reviewing the legalities:

India

The Companies Act 2013 has made it mandatory for listed companies or such class of companies to establish vigil mechanisms for their directors and employees, in order to report genuine concerns in the recommended manner.

Clause 49 of the SEBI listing agreement also lays down similar provisions. Since drugs relate to patient safety, a sensitive subject, the CDSCO has devised a reward scheme for blowing the whistle on spurious or fake drugs.

USA

Under the Dodd-Frank Wall Street and the False Claims Act, an individual with knowledge of fraud committed by a business may blow the whistle to defined regulatory bodies.

If the claim is proven valid, the whistle-blower is entitled to a percentage, or “bounty”, of the sum recovered. Additionally, the Department of Justice (DoJ) has enforced CGMP violations under the False Claims Act.

Case Study

A bounty-ful reward An employee of a leading company blew the whistle on the company’s questionable manufacturing practices.

This was corroborated by providing evidence to the regulatory authorities on the company falsifying drug data and violating good manufacturing practices.

The investigation resulted in the drug maker pleading guilty to the wrongdoing and paying a hefty sum in settlement. The whistle-blower was awarded a significant sum from the regulator.

Does your organization have a whistle-blowing mechanism to report and investigate quality concerns, if any?

Did you know?

The CDSCO has implemented a reward scheme for individuals who report companies manufacturing fake or spurious drugs.

Association of Certified Fraud Examiners reports that whistle blowing is the most powerful method of identifying fraud in organizations.

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Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

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Understanding basic difference between Form 483 & Warning Letters

The Form 483 & FDA Warning Letter both serves a similar purpose to inform sponsors & principal investigators of issues requiring corrective action.

An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice. You need to respond in writing within 15 days of receiving both a 483 & a warning letter.

If you receive a warning letter, you’re required by law to make any changes necessary to satisfy the FDA’s concerns. A warning letter is far more serious than a 483 observation.

Any violations must be dealt with before you can meet compliance and bring your medical device to market.

What is FDA 483?

The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) “Factory Inspection”.

Form FDA 483, “Inspectional Observations,” is a form used by the FDA to document & communicate concerns discovered during these inspections. Also referred to as “Form 483” or merely “483”, it states thereon that it

The FDA Form 483 is officially called a “Notice of Inspectional Observations,” commonly referred to simply as a “483.”

The 483 is issued at the end of an on-site inspection if the FDA field investigator observed deficiencies in your quality system or conditions that violate the Food, Drug, or Cosmetic Act.

Lists observations made by the FDA representative(s) during the inspection of your facility.

They are inspectional observations, and do not represent a final Agency determination regarding your compliance.

A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.

Responses should be comprehensive, well-reasoned, well-documented and timely, and that each observation should be addressed individually.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.

Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

Respond to the 483 or a Warning Letter promptly & identify your course of action to correct the findings within the FDA’s specified timeframe

The best way to minimize your chances of receiving a Form 483 is to always be “inspection ready.”

How Do I Respond To A Form 483?

You are obligated to respond to an FDA 483 observation in writing within 15 days.

Before an inspector leaves your facility, you’ll receive a draft of their inspection report (known as an Establishment Inspection Report, or EIR) as well as drafts of any 483 observations.

They’ll ask you whether you plan to address those observations, too

You should take time to review the Form 483 with the inspector once the inspection is finished. This is your opportunity to:

Gain an understanding of observations noted & assure their accuracy
Understand the broader message the agency is sending
Identify & discuss any errors in observations
Ask questions
Demonstrate awareness of applicable regulations
Consult with legal counsel as necessary

What is Warning Letters?

An FDA warning letter is an official message from the United States Food & Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.

The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.

The FDA defines an FDA warning letter as:

“A correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.”

Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes.

Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.

A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.

Instructions for the response

The Warning Letter provides instructions, as appropriate, stating that the organization’s response must include:

“Each step that has been or will be taken to completely correct the current violations and to prevent similar violations;
The time within which correction will be completed;
Any reason the corrective action has not been completed within the response time; and,
Any documentation necessary to show that correction has been achieved.”

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

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Do’s and Don’ts During FDA Inspection

Do’s:

• Answer all questions honestly;

• Say “I don’t know” or “I’ll get the answer for you;”

• Avoid such phrases as “I think,” “Sometimes/often/usually,” “never” and “next time;”

• Avoid qualifiers, such as “typically,” “normally,” “generally” and “usually;”

• Stop speaking once the question is answered;

• Ask for explanations or interpretations of what you do not understand;

• Maintain a friendly and cooperative attitude;

• Control your temper; remain courteous & professional

• Maintain eye contact.

Don’t:

• Volunteer information or answer a question that hasn’t been asked;

• Be sarcastic;

• Guess answers;

• Attempt to answer “what if?” or hypothetical questions;

• Argue with an investigator;

• Philosophize, ramble or editorialize;

• Point out deficiencies or errors;

• Apologize for problems or comments made by an investigator;

• Feel the need to respond to every comment made;

• Become defensive or evasive;

• Look away, fidget or look nervous

• Make statements about your personal opinion of the FDA.

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

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You must know Inspection Techniques that followed by your next Inspectors

What is QSIT?

QSIT provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer’s compliance with quality system regulations.

An FDA quality system inspection technique audit focuses primarily on four major subsystems and their respective documentation samples and is an efficient way to determine systemic weaknesses.

When an investigator conducts an FDA QSIT inspection, medical device companies can expect shorter audits and more serious repercussions—especially to upper management.

QSIT identifies the four major subsystems of the quality system:

Management Controls,
Design Controls,
Corrective and Preventive Actions (CAPA),
Production and Process Controls.

1 QSIT Management Controls

Inspectional Objectives:

1. Verify that a quality policy, management review and quality audit procedures, quality plan, and quality system procedures and instructions have been defined and documented.

2. Verify that a quality policy and objectives have been implemented.

3. Review the firm’s established organizational structure to confirm that it includes provisions for responsibilities, authorities and necessary resources.

4. Confirm that a management representative has been appointed. Evaluate the purview of the management representative.

5. Verify that management reviews, including a review of the suitability and effectiveness of the quality system, are being conducted.

6. Verify that quality audits, including re-audits of deficient matters, of the quality system are being conducted.

At the conclusion of the inspection….

7. Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.

2. OSIT Design Controls

Inspectional Objectives

1. Select a single design project.

Note: If the project selected involves a device that contains software, consider reviewing the software’s validation while proceeding through the assessment of the firm’s design control system.

2. For the design project selected, verify that design control procedures that address the requirements of Section 820.30 of the regulation have been defined and documented.

3. Review the design plan for the selected project to understand the layout of the design and development activities including assigned responsibilities and interfaces.

Note: Evaluate the firm’s conduct of risk analysis while proceeding through the assessment of the firm’s Design Control system.

4. Confirm that design inputs were established.

5. Verify that the design outputs that are essential for the proper functioning of the device were identified.

6. Confirm that acceptance criteria were established prior to the performance of verification and validation activities.

7. Determine if design verification confirmed that design outputs met the design input requirements.

8. Confirm that design validation data show that the approved design met the predetermined user needs and intended uses.

9. Confirm that the completed design validation did not leave any unresolved discrepancies.

10. If the device contains software, confirm that the software was validated.

11. Confirm that risk analysis was performed.

12. Determine if design validation was accomplished using initial production devices or their equivalents.

13. Confirm that changes were controlled including validation or where appropriate verification.

14. Determine if design reviews were conducted.

15. Determine if the design was correctly transferred.

3. QSIT Corrective and Preventive Actions (CAPA)

Inspectional Objectives

1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.

2. Determine if appropriate sources of product and quality problems have been identified. Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.

3. Determine if sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.

4. Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.

5. Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.

6. Determine if failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity. Determine if failure investigations are conducted to determine root cause (where possible). Verify that there is control for preventing distribution of nonconforming product.

7. Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.

8. Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.

9. Verify that corrective and preventive actions for product and quality problems were implemented and documented.

10. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.

4. QSIT Production and Process Controls

Inspectional Objectives

1. Select a process for review based on:

a. CAPA indicators of process problems;

b. Use of the process for manufacturing higher risk devices;

c. Degree of risk of the process to cause device failures;

d. The firm’s lack of familiarity and experience with the process;

e. Use of the process in manufacturing multiple devices;

f. Variety in process technologies and Profile classes;

g. Processes not covered during previous inspections;

h. Any other appropriate criterion as dictated by the assignment

Note: If the process chosen is sterilization, evaluate the process according to the “Sterilization Process Controls” chapter of this handbook.

2. Review the specific procedure(s) for the manufacturing process selected and the methods for controlling and monitoring the process. Verify that the process is controlled and monitored.

Note: Control and monitoring procedures may include in-process and or finished device acceptance activities as well as environmental and contamination control measures.

3. If review of the Device History Records (including process control and monitoring records, etc.) reveals that the process is outside the firm’s tolerance for operating parameters and/or rejects or that product nonconformance’s exist:

a. Determine whether any nonconformance’s were handled appropriately;

b. Review the equipment adjustment, calibration and maintenance; and

c. Evaluate the validation study in full to determine whether the process has been adequately validated.

4. If the results of the process reviewed cannot be fully verified, confirm that the process was validated by reviewing the validation study.

5. If the process is software controlled, confirm that the software was validated.

6. Verify that personnel have been appropriately qualified to implement validated processes or appropriately trained to implement processes which yield results that can be fully verified.

Source: GUIDE TO INSPECTIONS OF QUALITY SYSTEMS GUIDE TO INSPECTIONS OF QUALITY SYSTEMS August 1999

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

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What FDA will Expect from your Next Inspection?

In Earlier post we understood What is Agenda for your Next Inspection in Pharma Industry?

Now in this article we are going to understand What FDA will expect from your Next Inspection.

FDA conducts Inspections to Assess compliance with applicable Laws and Regulations

Investigators to conduct inspections in a Reasonable manner
Industry to welcome the investigator professionally and do all they can to facilitate an efficient inspection
For Minimal delays to occur at the outset of unannounced inspections; no delays when the inspection was pre-announced
For information to be provided as Swiftly as possible without delay; if you don’t know the answer, explain you don’t and get the person who does know as soon as you can
To be provided with access to all locations and records related to the manufacturing process; which means every step of the way (no “secret” rooms)
Courtesy and Respect shown by all parties
Investigators to openly communicate the scope of the inspection and findings at least daily
For contentious issues to arise and for there to be open dialogue; communicate to avoid misunderstanding
For industry to have procedures for inspections/audits
For there to be a “War Room”
For investigators to conduct efficient inspections with asLittle disruption to operations as possible
For copies of records to be provided in aTimely manner
That inspected parties will be nervous (it’s ok, the investigator is too!)

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

Innov@tive App

Agenda for your Next Inspection

In Earlier post we understood What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry?

Now in this article we are going to understand What is Agenda for your Next Inspection in Pharma Industry?

Inspection Agenda:

Looking at some crucial points that ensure data integrity, it quickly becomes clear that this is not a new element of inspection.

Inspection Agenda includes:

ALCOA Principle
Audit Trail
Data Review
File Format
Storage Media(Disaster Recovery/Data Backup)
Data Encryption
User Management (Level of Access)
Review of the Data Life Cycle
Handling of Raw Data
Data Security (Alter/Delete/Modify Data)
Access Control of Critical Area

These points have always been part of the inspection’s agenda.

Subsequently in can be said that data integrity is not only an IT topic; it includes all areas of the documentation.

The requirement that every change to a document has to be initialed and dated and that the original information has to stay legible despite all changes, is of essential importance for paper documentation as well as electronic documentation.

For electronic documents, this should basically be implemented through validated audit trail functionality. Many companies are still struggling with this, particularly as there aren’t any acceptable systems available, sometimes.

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

Innov@tive App

What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry?

In Earlier post we understood Preparation of Successful Inspections & Preparation tips which useful in during your next inspection.

Now in this article we are going to understand What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry?

Mock Inspection:

Mock FDA inspection is an essential tool in identifying issues that could affect the quality of manufactured pharmaceuticals or medical devices, and become compliance issues with FDA.

Mock inspections help to determine audit readiness by testing knowledge of procedures and by creating a process that simulates the pressure of an actual inspection.

One of the most effective methods to prepare SMEs is to conduct mock inspections.

What is Mock Inspection?

Mock audits are simulations of actual FDA audits conducted to assess Good Clinical Practice, Good Laboratory Practices, and Good Manufacturing Practices.

MHRA has said, “QA should also review a sample of relevant audit trails, raw data and metadata as part of self- inspection to ensure ongoing compliance with the data governance policy/procedures.”

According to PIC/S, “The effectiveness of data integrity control measures should be assessed periodically as part of self-inspection (internal audit) or other periodic review processes. This should ensure that controls over the data life cycle are operating as intended.”

Mock inspection can be performed by:

• Internal team using FDA procedures
• External team of ex-FDA employees

An internal team consists of qualified professionals with experience in regulatory compliance.

If an external team is used, it generally consists of members of an outside consulting firm with FDA work experience.

Purpose of Mock Inspection:

Determination of what inspectors are looking for during an actual inspection.
Preparation for an actual FDA inspection.
Identification of common issues of compliance & learn how to rectify them

Prepare for inspections, it is useful to have an external organization perform a mock inspection.

A mock inspection simulates an actual inspection and the inspection report is structured in the same way as an inspection report from a regulatory agency.

Outcomes of Mock Inspection:

• Obtain evidence that management is overseeing operations effectively
• Review the compliance of contract service providers
• Verify that quality assurance and regulatory affairs departments are operating appropriately
• Evaluate process controls, records, and document controls; and
• Determine whether the mechanisms are compliant

Day wise Mock Inspection:

A mock audit is usually conducted over four to five days and utilizes FDA inspection procedures. At the end of each day, the auditor provides a recap of findings at a closing meeting and identifies personnel to interview.

Day One: Mock inspector’s meets with people from the company, tours facilities & reviews internal quality files.
Day Two: Mock inspector’s reviews the policy for retaining records & product controls at facilities.
Day Three: Mock inspector’s reviews procedures for corrective action plans, handling of complaints & oversight of suppliers.
Day Four: Mock inspector’s reviews any remaining compliance programs & interviews any personnel that he or she still needs to interview.
Day Five (if needed): additional areas of the quality systems not previously covered will be reviewed.

End of the fourth or fifth day, mock inspector conducts an exit meeting with company. During this meeting mock inspector provides a review of major & minor findings & suggests actions to improve the issues they found.

Mock inspection move around:

Mock inspection moves around three factors People, Preparation & Process.

People- Put right people in right roles.
Preparation Appropriately prepare team & documentation.
Process Follow industry standard inspection process.

Mock FDA audits are important for the identification of gaps in the quality systems related to pharmaceutical or medical device manufacturing.

Across the internet, there are millions of resources are available provide information about almost everything.

Data Integrity App Complete reference for Pharma IT Compliance

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

Current Regulatory Agencies thinking on Data Integrity.
Importance of Mock Inspection & its tricks and techniques how to conduct.
Checklist for Inspection
Best Practices for CSV.
Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

Innov@tive App

GxP Assessment of computerized system:

System Categorization:

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Steps which never missed in computer system validation.

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History of CSV:

What is CSV?

Purpose of CSV:

Why CSV:

Benefits of CSV:

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Whistle-blowing:

Whistle Blowers Types:

Law that protect Whistle blowers:

Reason of whistle-blowing

How to avoid whistle-blowing?

Steps to a Successful Whistleblower Claim:

Reviewing the legalities:

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How Do I Respond To A Form 483?

What is Warning Letters?

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Do’s:

Don’t:

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Day wise Mock Inspection:

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