Keep Up-To-Date On Regulatory Changes and Trends

 

Data Integrity App


Nowadays, a serious breach in compliance matters cannot be left without being penalized and sometimes it gets published in the media, causing reputational and economic damage to companies and to individuals.

Enforcement actions evolve over time, and it is important to be aware of current trends. All of this information is publicly available.

Enforcement actions can be monitored by review of available form 483s, warning letters, Eudra GMDP reports of noncompliance, and WHO’s notice of concern.

 It is the right time to start paying attention to the regulations and to use all the possible resources that a company allows to comply with the requirements of the law.

Here are some tips which will facilitate the process of knowing the regulation and implementing it internally:

1.     Enroll in newsletters with updates from the Regulatory bodies. This will enable you to know when there is a new regulation that concerns you and what are its requirements and deadlines;

2.     Participate in seminars, conferences or web trainings that inform you on how the new regulation must be implemented. When this is not possible, reading summaries prepared by professionals could be also useful; as it is preparing a summary yourself. Don’t forget to highlight items like: concerned parties, requirements, deadlines and penalties. 

3.     Check your internal procedures and think of ways how to introduce the new requirements into the existing procedures.

4.     Inform all the staff on the new regulatory requirements and refresh their knowledge. Compliance is not just a responsibility of the Management and of the Compliance Officer – It is the job of everyone who works in the financial sector to be alert.

 

5.     Inform the clients on the new regulatory requirements and make it clear for them that respecting the law is not optional and that it is in the common interest to comply with the laws.

 

6.     Document everything and keep records of work that is done, of work in progress and of work to be done with regards to compliance.

7.     Appoint a Compliance Officer. If it is not possible, appoint a single person in charge of your company’s compliance operations and have her/him trained.

8.     In cases of need engage professional advisers in the sector in short term or in permanent term. It might have a high cost in the short term but it will bring you long term profits and the comfort of a ‘healthy’ continuation of your business.

 

“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


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