Ensuring Data Integrity in the Pharmaceutical Industry: Challenges and Best Practices

Abstract

One of the most important and crucial part that always overlooked in the pharmaceutical industry is the Data Integrity aspect of the industry. Data is the most important thing that can be misused, altered and vulnerable to inconsistency, maintaining its integrity is most crucial challenges in the pharmaceutical industry in recent years, this has forced the regulators like FDA, WHO and MHRA to impose a strict guideline that should be followed to maintain compliance and to prevent the data manipulation, error or loss. Data Integrity Ensures that the data is accurate, complete with zero alterations and most important it is secure, However, many pharmaceutical companies face the significant challenges such as poor documentation practices, human error are the most common challenge in pharmaceutical industry, as digitization spreading its roots so the need of cyber security is critical and lastly the loopholes that need to be covered and vulnerability in handling the manuals and electronic data management systems. Therefore, to overcome all this challenges, concerns and adopting to the best practices, Data Integrity follows the AlCOA+ principles combining them with Good Documentation Practices (GDP), and also the need of electronic data management system has become essential. Additionally, advancement in the latest technologies such as automation, blockchain and AI-Driven compliance/guidelines monitoring system will play a significant role in improving data integrity. The purpose of this research paper is to explore the expectations of regulatory agencies, key challenges and practical solution to strengthen data integrity within the pharmaceutical industry. This paper also highlights the role of advanced technologies and regulatory compliance strategy to ensure the data integrity.

Keywords

Data Integrity, AlCOA+, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Pharmaceutical Industry, Regulatory Compliance, Digitization

Introduction

Above Fig.1, shows the concise summary of how the data can be secure and by using this we can maintain the Data Integrity.

REGULATORY FRAMEWORK FOR DATA INTEGRITY:

Rising concern of data integrity in the pharmaceutical industry has alarmed the regulatoy bodies to strenghthen and enforce best practices to ensure complaince. If any pharmaceutical company failed to follow this guidelines may result in financial penalties, product recalls, and lagal actions.

The 5 major regulatory bodies with their guidelines as follows:

1. U.S Food and Drug Administration (FDA):
   • Under 21 CFR guideline part 11: states that the use of electronic record and electronic signature, ensuring that the data is trust worthy, secure, relaible and is on par with handwritten records.
   • FDA’s Data Integrity and Complaince with Drug CGMP “Question and Answers ” guidance for industry, pusblished in 2018: States the importance of data integrity in current Good Manufactuing practices and clarify that data should be secrure from manupulation and ensure its relaibility when the records are related to the drug manufacturing and quality control
2. World Health Organisation (WHO):
   • Annex 4 of Technical Report Series (TRS), 1033 of WHO:This guidline focuses on maintaining the realibility and trutworthiness of data that is used in the production, comtrol and registration of pharmaceutical products.
   • Guidline on Data Integrity- Technical Report Series (TRS), 1033 (2021): This Guideline provides the information, guidance and recommendations on how to strengthen the data integrity of product quality, safety and efficacy.
3. European Medicine Agency (EMA):
   • EudraLex Volume 4: Volume 4 focuses on the European Union’s (EU) Good Manufacturing Practice (GMP) guidelines which states that ensure the documentation standards required for GMP.
   • Annex 11: This specific annex focuses on computarised system, as they are most important in storing the data, processing it and retrieving whenever it is needed in the industry.
4. Medicine and Healthcare Products Regulator Agency (MHRA)-UK:
   • Guidance on GxP Data Integrity (2018): The scope of this guidance aims to cover the core element of a complaince in data governance system, also addresses the fundamental failure which occurs during the inspections and direct them to follow the complaince through education.
   • MHRA’s expectations to regulate this guidelines among all sectors including GLP, GMP, GCP, GDP and GVP

As we gone through the regulatory agencies there was a critical focus on integrity of the data, there expectations can be summarised such as:

• They directly and Indirectly focuses on the ALCOA+ principles.
• Transition from traditional system dosent mean that the safety of paper documentation not need to be maintained instead, both paper based and digital system should be protected againts any manipulation and tampering.
• Periodic or regular audit trails should be done to keep checks on any changes, updation/deletion or manipulation of the records has been done.
• Every data should be retained till the said complaince duration by the respective companies for product safety and efficacy evaluation.
• Those employee who works on the handling the data should be trained and kept updated with the recent technologies so that we can minimize the human error and accidental misconduct.

CHALLENGES IN ENSURING DATA INTEGRITY:

Sinse we have seen there are strict gudelines by the regulatory agencies to control the issues related to data integrity. This issue cannot be viewed by using the surface paramaters but we need to dive deep into this, despite strenghthening the regulations and complaince this issue remains somewhat complex and still a on going challenge for pharmaceutical industry which is leading cause in comprimising the relaibility of the data, compliance issue which eventually leads to product recall and reputational damage to the pharmaceutical companies. Following are the common challenges in terms of Data Integrity faced by the pharmaceutical companies:

1. Human Error and Poor Documentation practices: One of the root cause in maintaining the data integrity is human error, most of the time it is unintentionally but the outcome still leads to the major issues. Major issues can be discussed as follows:
   • Mistakes during entering the data into the system: This mistakes can be as small as spelling errors but can be major issue when it comes to interpretation of data. Sometimes overlooking crucial details can cause inaccuracies.
   • Data Manipulation or  Accidental deletion of data: Unintentionally alteration of data or deletion of data can cause the integrity issues of records.
   • Wrongly Configured System: Sometimes setting up incorrect system configuration can lead to unauthorised access to the system which may cause the data to be leaked or modified when it will be accessed by unintented manner.
   • Failure to follow Good Documentation Practices: Not following the GDP and also lacking in following the SOP’s will eventually result in inaccruate data collection and management.
   • Lack of Training and Awarness of new System or Technology: Not providing sufficent training regarding new practices related to data integrity may lead employees to make mistakes and overlook the crucial details.
   • Manually Entering the Data: Records written by hand is more prone to mistakes that are caused by Human Error.
2. Data Falsification and Manipulation: It is a major threat when it comes to data integrity in the pharmaceutical companies, it causes vulnerability to product quality and if product is comprimised it can lead to patient safety issues. Data falsification is mainly caused due to pressure in companies to meet the target on time or sometimes to avoid the regulatory scrutiny. Following are the common data falsification issues:
   • Deleting the data or making unintended changes in it to show the false picture of results.
   • Not keeping track of records and data changes makes it difficult to trust the data and at the end it fails to verify the integrity of the data.
   • No proper authorization for accessing the system, unauthorised access to the data may lead to the trustworthiness issue and poor handling of data.
   • Last it again comes to the important point that poor training or lack of training regarding the principles of data integrity and  safe data management practices can lead to data integrity issues
3. Lack of Data Governanace Policies: A lack of strict data governance policies in the pharmacetical companies can severly affects the data integrity which steer to legal issues even endangering the patients safety. Following are the issues that need to be looked closely to avoid poor data governance:
   • Companies failing to follow the data governance policies comes under the perview of regulatory agencies guidelines and may get the warning letters citing to meet the specific governing criteria and also may endup with legal trouble which directly leads to product recall and even imprisonment in some cases.
   • Failing to adher proper data governance can cause data manipulation and indirectly it affects to patient safety.
   • As stated earlier if this issue causes harm to patient safety, the companies may also get a lawsuit and then they have to go for a costly recalls which will damage their reputation in the market which will impact the companies performance in the future.
   • A damaged reputation of a company will break the trust among investors, partners and most important the public.
4. Cyberthreats and System Vulnerabilities: Adopting to digitization of documentation such as keeping the record in electronic form has its own advantage, but there comes a hidden a issue that is often underestimate is the cyber threats. Growing digital record keeping has a major risk of cyber attacks that have become a significant challenge to pharmaceutical industry. Companies often stores large amount of sensitive data which includes the data of clinical trials, drug formulation reports and supply chain records. Following are the potential risk associated with digital data keeping:
   • Data breach can cause major leak of sensitive information, hackers can steal the information relatead to patient test data, trade secrets of company or companie’s intellectual property rights and all this can lead to huge financial and reputational damage and can also face legal concequences.
   • Second most critical attack that are prone to happen if there is no proper cybersecurity used in the system is the ransomware attack, where hacker can gain access to the companies system and encrypt all the data until the ransom is not paid to the hacker, this can lead to huge financial loss to company.
   • Intellectual Property (IP) theft: Companies all experiments related data, all its formulas, research data and what kind of technologies used for doing the research are all stored under the Intellectual Property rights, if this rights gets hacked then there will be major downfall for that particular company
   • Regulatory Complaince Breach: This occurs when companies are not able to protect sensitive data then they directly comes under the perview of regulatory agencies and are liable for fines and legal liabilites
   • Cyber threats occurs when the cybersecurity is weak and this is majorly one factor that is less investment in cybersecurity by the companies.
5. Inconsistent Validation of Computerized System:As mention in cyberthreats, the shift to compterised system is a major advantage but can cause significant issue in managing it. The systems used in the companies are mostly running on old generation softwares and operating system which do not have proper support for managing the system security, if this systems are not properly tested and validated it will pose a significant risk such as:
   • Stored data will be inaccurate.
   • If there is a delay or lack of audit trails that can track the modification or any alteration in the data will give inconsistent result.
   • Installing unverified softwares and files  may lead to the hijicking of the system and eventually prone to alteration of data.
6. Employee lacking the necessary training: If the companies have everything neatly setup it may be following the guidelines, strenghtheing the validation system etc. still there will be a room for mistakes if the employees are not properly trained for required system and policies in place, common issues that emplyoee lacks are:
   • Taking the record-keeping in a light manner, by overlooking the accuracy which may lead to human errors.
   • Employees are not trained enough on the ALCOA+ princliples and Good Manufacturing practices which are most crucial part in data integrity.
   • Unauthorized access to electronic data management system may lead to misuse of the data.

BEST PRATICES TO MAINTAIN DATA INTEGRITY:

As we have seen there are so many pressing issues related to data integrity which require immediate attention. List of guidelines and regulation won’t work if there are no proper practices to impement them, until then the issues will remain a point of concern. So, proceeding with best practices that can help pharmaceutical companies maintain their integrity while handling the data. A company can implement a structured and proactive measures to secure its data and maintain the integrity while aligning its principles with regulatory expectations. By implementing the best practices can help a company to maintain accuracy, relaibiity and security in managing the data.

1. IMPLEMENTING ALCOA+ PRINCIPLE:

A: ATTRIBUTABLE

L: LEGIBLE

C: CONTEMPORANEOUS

O: ORIGINAL

A: ACCURATE

+: COMPLETE, CONSISTENT, ENDURING & AVAILABLE

ALCOA+ principles are the foundation of data integrity in pharmaceutical industry. Plus represents the extention of the original ALCOA principles. Each principle plays a significane role in providing a proper guidance on how to maintain the integrity of the data.

As above each principles has its own unique guidline and going in detail of each guideline starting with:

1. • ATTRIBUTABLE (A): This principle focuces on the change or manipulation of data. It specifically states that whenever the action is performed on the data, the performed action should be recorded along with who performed that action. If any updation or modification of data has been done then there should be a specific reason to perform the modification, it is mandatory to note down in record that who has updated/modified the data and why they modified it.
   • LEGIBLE (L): This principle clearly states that the recorded data should be in readable form. Anyone should be able to read the data that has been recorded and most important this data should be stored in durable hardware medium so that the risk of damaging the data is minimised.
   • CONTEMPORANEOUS (C): Every work has its deadline and should be performed in that given time. This principle states that the real time data should be recorded to keep track of completion of work on time.
   • ORIGINAL (O): Keeping track of record for information about whereas tasks is essential, this principle thus focuses on the information that record hold should mention that it is a original copy or a true copy.
   • ACCURATE (A): This principle states that the data that has been recorded or in the process of recording should be free of errors and and no unauthorised alteration has done to it.
   • Plus (+): This is the extention of original ALCOA principles
     1. COMPLETE: This principle states that any reanalysis done on the sample should clearly mention that in the records.
     2. CONSISTENT: This principles clearly points out that the data should always be recorded in choronlogical order and the sequence must be followed.
     3. ENDURING: All the records should be maintained in a proper manner and should be able to store for a required time that is specified by the regulatory authorities.
     4. AVAILABLE: All the required data or records should be available whenever there is an audit.
2. STRENGTHENING OF GOOD DOCUMENTATION PRACTICES (GDP)

There should be a clear focus on adopting Good Documentation Practices (GDP) through proper training to emplyoee along with utilising the effectiveness of modern systems like Eelectronic Data Management System (EDMS) and also focusing on the ALCOA principles. Key GDP guidelines that can be included in the measures are as follows:

• Following the SOP’s and rules to record data in logbooks is crucial, it allow data to be traceable and will enable companies to track the process for manufacturing to distribution of the product in the market.
• Avoiding unwanted editing of the document without prior justification of the action.
• Record should be created in continous manner alongside of the acitivity or any actions that has been performed to maintain the timeliness of the record.
• Version control of the document should be maintained so that it will ensure that the latest version of the document is used.
• Authorization should be in place, so that if any record has been modified or changes it should be immediately authorised and signed by the authorised personnel.
• Every documents before forwarding should be crossed checked by reviewing and validating the records.
• Timely audits of the records and documents will minimise the risk of human error and can improve documentation practices.

3. IMPROVING THE ELECTRONIC DATA MANAGEMENT (EDMS)

Making the transition from paper-based documentation to the digital Electronics Data Management System is essential move in handling the data and storing it in a electronic manner this will help in maintaining the integrity of the data with only authorised person allowed to access the data, this will reduce the human error and manipulation of data. Having a EDMS dosent mean that all the records saved on the system is safe, there should be a proper checks to know that the system is working fine:

• Only validated softwares should be installed on the system for secure data storage.
• Use of automation to keep track of any changes that takes place on the system.
• Access should be awarded only to authorised personnel to prevent the unwanted alteration of records by unauthorised access.
• Backup is the crucial part of EDMS, everything from record to document should have its backup ready in the system, if one fails due to any reason the company will have its backup.

4. REGULAR INTERNAL AUDITS AND REGULATORY COMPLAINCE CHECK

To identify and address the potential issues releated to quality, safety and complaince it is important to have a regular internal audit to keep checks on the paramaters that mentioned earlier. Audit helps in identifying the gaps in data integrity practices that have a potential risk in voilating the regulatory complaince. Here the measures companies should include to avoid the compliance issues:

• Planning and preparation of the audit should be done by defining the scope of the audit on which particular area or process is audit taking place.
• Audit schedule should be based on the risk factor and on going regulatory requirements, after identifying the risks and requirment a audit team should be formed who are experts in the relative field.
• Team needs to declare a proper scope, objectives and what methodology do they are using along side the timelines that needs to be mentioned to create a proper audit. While mentioning the timeline they need to firstly go throught the previous audit report and see through that previous corrections has been implemented.
• After reviewing all the crucial points that needs to considered before audit began, there should be a team meeting with higher management to discuss the scope, methodology, objective and schedule of the audit and then procced to gather all the relevant documentation, data and records that will be supporting audit findings.
• Not just looking into the data and information is necessary but also on field inspection of equipments, facility and processes that takes place is also requires same attention.
• Lastly after analysing all the required data and drafting the audit report where it summarise the findings, loop holes, and setbacks that needs to be overcome and should also consist of recommendations for corrections.
• This draft should be shared with higher management for review and feedback form them and after the approval of the management, the final draft of the report should be prepared as per the feedback.
• Final report should be conclude with area of improvements and should address the non-complaince.

5. STRENGTHENING OF CYBERSECURITY MEASURES:

The transition from traditional system to digital electronic data management system was a boon to pharmaceutical industry but it comes with major risk of cyber threats and are prone to cyber attacks, if the cybersecurity is not upto the mark then there is major risk of hacking and security breach that can lead to loss of data and intellectual property theft that can severly impact the reputation of the company. Following are the cyber security measures that a company should follow:

5. • Proper installation of firewall in network to avoid unwanted access to the system.
   • Records that are on the system should be in encrypted format so that if the system is compromised the data should be safe.
   • Attempt to unauthorised access should be detected and blocked automatically.
   • Should implement Multifactor Authentication (MFA) so that when trying into logged in to the system required second layer of authentication.
   • All the softwares should be updated so that any vulnerabilities and loop holes will be avoided.
   • After ramping up the cyber security measures it is essential to train emplyoees on this new measures on how to identify the phishing attacks and unauthorised access to the system.
6. ADOPTING EMERGING TECHNOLOGIES FOR ENHANCED DATA INTEGRITY:

Ramped up cybersecurity will help in mitigating the risk of cyber attacks but integration of new technologies will give another edge on not only securing the integrity of the data but will also give an addon security layer to the system. Following Emerging technologies can be implemented withing the system:

• Blockchain: storing the data in chunks of blocked that are linked together in chain like manner and this data cannot be deleted and tampered until you have permissions in the network to do so, and main advantage of this technology is that the data is not stored in centralised manner but stored in decentralized format.
• Artificial Intelligence (AI): Integration of AI in the system can detect the uneven changes in the system and can report the potential threats even before it takes place.
• Automation and Machine Learning: This will be most usefull tool when it comes to reducing the errors. Manual entry and record keeping may lead to human error but use of automation and machine learning can reduce the risk of errors.

7. REGULAR EMPLOYEE TRAINING AND AWARNESS PROGRAM:

Lack of expertise which is caused when employees are not aware of the working procedures and technology which can lead to unintentional data integrity voilation. Therefore regular training of employees are mandatory to reduce human errors, the focus of training programs should revovle around the key points:

• Training employees on the ALCOA+ principles and Good Documentation Practices can make a huge impact on maintaining the data integrity.
• Training the experience employees on how to conduct audit trails and how to use the EDMS.
• Promoting a fear free enviroment where employee can report any small changes or inconsistency regarding data integrity.

8. STRONG DATA GOVERNANCE FRAMEWORK:

To maintain the data accountability and consistency throughtout all levels there should be a well stuctured data governance policy in place. This should include following key points:

• Assiging a chief data integrity officer to look into the matter of monitoring and ensure best integrity practices are followed.
• Create a Standard Operating Procedures (SOP) that should be strictly followed for proper data management.
• Create a proper feedback or reporting that should be free of external influence so that transparency is maintained while reporting data breaches.

Implementing the above practices can help in mitigating the risk of integrity of data.

CASE STUDY ON DATA INTEGRITY ISSUES AND COMPLIANCE SUCCESS OF PFIZER:

Data integrity issue in pfizer pivotal covid-19 vaccine trail: In November 2021, there was concern spreading regarding the vaccine trial of covid-19 which was made by pfizer on the issue of data integrity was not maintained during the phase-III trails of the vaccine. The employee from Ventavia Research group who was on the position as a regional director has told the BJM that pfizer has altered the data and has falsified its report and data by keeping the patients unblinded along with untrained vaccinators. Pfizer was also very slow to report the adverse effects of vaccine during the phase-III trails. The employee who reported all this findings to FDA was fired with immediate effect by ventavia without prior confrontation. The employee goes by the name “Jackson” wrote in a email to FDA the following concerns about how the trails were conducting in the labrotory:

• Trail participants were left unattended and placed in hallway after the had there injection and clinical staff was not present to monitor them
• As there were some adverse effects shown after the vaccination, there were no timely followups of patients.
• There were also some deviations in the protocol which was ignored and not reported to the concerned authority
• Proper GMP were not followed and vaccines were not stored in required temprature.
• As testings were going on there was so many cases of mislabelling of specimens with other and created a risk of inaccurate data management.
• There were also events when this issues was pointed outby some staff members working with ventavia, they were targeted for reporting the issues.

This concerns where acknowledged by the FDA and thanking Jakson for raising her concern but unffortunatley there was no further development in the complain that was raised with FDA. In august 2022, when the full approval of vaccine the FDA published a summary of inspection where the trails took place but there were no mention of ventavia’s trail site due the onongoing trails. The officer incharge of inspection notes: “The data integrity and verification portion of the BIMO (Bioresearch Monitoring) inspections were limited because the study was ongoing and the data required for verification and comparison were not yet available to the IND (Investigational New Drug).” RESPONSE FROM REGULATOR: The European Medicines Agency (EMA) looked into the matter of allegations and came up to the conclusion that the identified issues will not compromise the overall integrity and quality of data. Also the benefit-risk assessment and conclusions will be free from impact of vaccine safety and efficacy. Additionally, science based medicine states that while the ventavia where responsible to take the trails of vaccination on very small fraction of trail sites, specifically they were only responsible for 3/153 sites where approximately 1,000 participants out of 40,000 where taking the trails of the vaccine. EMA also stated that while the allegations and the reported issues where serious but there scope was limited when compared to entire trails.

PFIZER RESPONSE AND COMMITMENT RELATED TO THIS ISSUE:

In response to allegtions and reports Pfizer Chairman and CEO “Albert Bourla”, wrote an open letter to ensure the public trust and also to clear all the confusions revolving around the issues about trails. He stated that pfizer a committee of independent scientist will review the complete data whether the vaccine is effective or not and pfizer will continue its trails until the final analysis report is available. During this mean time we will share the positive and negative impact of vaccine soon with public. To act on this alleged issues pfizer stated that it was commited to use the integration of AI (Artificial Intelligence) and will also return the participants trail data.

• Integration of AI: using AI to integrate the clinical trail data, this integration will not only help to improve the accuracy of the data but will also maintain the integrity of data.
• Initiative to retun the data to the respective participants: Company in regards to increase the transparency will also rnthe initiatve to return the data of the participants those who participated in trials, this move not only increase the tranparency but also increase their trust in participants.

FINAL CONCLUSION ON PFIZER CASE STUDY:

• Importance of Rigorous Data Integrity Compliance
• Effective oversight of Contract Research Organisation (CRO’s) to conduct frequent audits and inspections on thirdparty sites.
• Whistleblower should be protected using ananymous reporting and the ethical reporting culture should be promoted
• Huge need for integration of AI and Digital technologies in the clinical trials.
• Transperacny during clinical trials is crucial to maintain the trust in public and participants that takes part in trials.

Final takeway from this pfizer case would serve us a reminder of how issues can escalate to inadequate oversight, weak governance and ethical setbacks in pharmaceutical research. Need of compliance and ensuring it along with transparency will make a hug impact in conducting a ethical trials which will generate the trust in public.

FUTURE TRENDS AND RECOMMENDATION

Data integrity is still a evolving topic in pharmaceutical industry. There is a continous need for adaption to advance technologies and adaption to regulatory changes and its compliance, so it is necessary to be able to make a shift to demanding change to face the complex challenges of data integrity and how to handle to problems. Pharma 4.0 gives us the insight on how we can integrate advance digital technologies into pharmaceutical industry. Pharma 4.0 : It is term that dicuss about on how to integrate the advance technologies in pharmaceutical industry. It will give an technological boost to pharma industry by leveraging technologies like connectivity, increased productivity, simplified the regulatory compliance and will also help in enhance the efficiency and effectiveness of manufacturing the high quality products and drugs. The term pharma 4.0 was coined by International society fot Pharmaceutical Engineering (ISPE) to boost the use of advance technologies in pharmaceutical industry. The aim was to create more productive, economical and patient friendly pharmaceutical industry by utilising the advance technologies.

Key Technologies of Pharma 4.0:

• Internet of Things (IoT): IoT’s are the devices that are fitted with sensors and softwares and can communicate with each other along with exhanging data without any external help.  This can be really useful in pharma industry to monitor and keep track of process in real time. Sensors fitted in them are well designed to detect the failure of the equipments and scheduling the maintaince of the same.
• Artificial Intellience and Machine Learning (AI/ML): As dicussed earlier AI/ML still remains one of the most important techological advancement a pharma industry can have. AI can not only predict the anamolies in the system but it is well trained to handle the anamolies. It helps in reducing the human error by automating a task to improve its efficacy. By use of machine learning and artificical intellegence we can train a AI model on the patients data and we can able to create a personlised treatments that suitable accordingly to the patients need.
•  Big Data Analytics: When doing research or creating a new drugs there is huge collection of data from patients and participants along with old research data, so to keep this at one place for easy access is a huge task. Here comes Big Data Analytics, where data storage are huge to accommodate large amount of data at one place. This data can be optimized and streamlined according to our needs. It will also give an insight where we can improve and optimize the process.
• Blockchain Technology: Blockchain is the key technology when it comes to improve the drug safety and to fight againts the counterfeiting drugs. It will not only help in improving the efficiency of the supply chain but will also help in maintaining the regulatory compliance.
• Robotics and Automation: Most of the major work in the pharma industry is to manufacture drugs and medical products. By streamlining the production and manufacturing with automation and robotics it will significantly reduce the risk of human intervention which ineventually causes the human error. We can also speedup the manufacturing process as machine are able to more than human, which will able to copeup with increased demand in production.

Benefits of this technologies will improve the manufacturing efficiency along with enhanced quality control and personalised treatments for patients. Companies need to invest more in available technlogies which will strengthen there compliance stratergies and can implement the active monitoring systems that meet the regulators expectations to safeguard the data integrity.

CONCLUSION:

Data Integrity have cameup as most important part of regulatory compliance in pharmaceutical industry, which is not only helping companies to meet the regulatory expectations but also corporate responsibility and patient safety. As the pharmaceutical industry continues to grow its is essential to maintain the integrity, relaibility and security of the data, in near future this will not only be for just the regulatory requirment but will also be a strategic requirment. To make sure people trust in pharmaceutical products along with clinical trails and manufacturing process it will be totally depended on companies to ensure solidly built governance policies should be in place.Increased demand in creation of complex drugs and major shift towards digital transformation with strict regulatory guidelines that needs to followed has made traditional data management methods outdated and time consuming. The required transition from traditional to digital system is essential to keep everything a right track allign with compliance and technology driven strategies. The integration of advance technologies discussed earlier will act as a control measure on how to safeguard data integrity. Lastly, solely relying on technology is not a solution. Companies culture plays a very important role to avoid human errors, data manipulation and unethical practices. Company that have transparency in their working culture along with accountability and continous learning enviroment is fostered that will make employees understand the significance of data integrity. By enforcing strict regulations and ethical practices will make sure that data integrity will be followed on utmost importance. Data integrity is not just about following the compliance but it is a way to build a future ready pharmaceutical industry.

ACKNOWLEDGMENT:

I would like to express my sincere gratitude to Prof. Dr. Ramesh R Pagore, his guidance played an important role in shaping my research..

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