Develop Site Procedures that Conform with Regulatory Requirements

 

Data Integrity App

◦ Single or multiple procedures

◦ Standard templates for documents

◦ Training on the procedures

 

The pharmaceutical industry is overloaded with regulatory documents, such as standard operating procedures (SOP),protocols and working practices, and needs a robust, understandable and effective architecture model to drive compliance.

Once the architecture is clearly defined, it’s important that the documents themselves should be easy to use and lead to compliance.

Remember, compliance is achieved through simplicity and clarity, not complexity or extensive detail.

The pharmaceutical industry could not function without all of its regulated documents, and there is nowhere where this is truer than in a manufacturing site.

 

RULES TO KEEP DOCUMENTS UNDERSTOOD

In writing the control documents, there are rules to guide the creation and management of controlling documents. Ultimately, the guidance is that the documents themselves should be clear, easy to use and lead to compliance.

  1. Aim for simplicity and clarity, avoiding complexity and the drive to cover all eventualities. Organizations must seek opportunities to reduce complexity as this will enhance the likelihood that people will comply, and result in fewer errors.  When organizations try to cover every possible situation, the documentation becomes so complex it becomes practically impossible to remain compliant with it.

  2. Be outcome oriented.  Building on the first rule, it is important to define the outcome required, not the input expected.  When organizations define the input, or activity, then the process can be adhered to without meeting the regulatory obligations set by the regulator.  When the outcome is defined, then the tasks become those that are required to meet the outcome, and compliance is not achieved unless the outcome is right.

  3. Don’t aim for perfection; use a risk-based model. The goal is to develop a good system that is fit for the purpose without a lot of complexity. Inevitably there will be circumstances that are not catered for within the documents; do not expect every possible eventuality to be covered.  

High frequency risks must be covered but low frequency high-impact risks are better managed by people reacting to the crisis rather than trying to mandate behavior a priori for every possible event.  Good controlled document architecture requires a risk based approach.


  5. Ensure different document types have clear guidelines for the different content required. It has to be clear whether a specific document mandates process or simply provides guidance; the selected document type must also reflect this intent.  

For example, policy documents set the ambition, a quality management system (QMS) lays out the scope, SOPs define how the scope is to be met and work instructions and other documents cover specific needs without covering all eventualities.


   6. Remember that regulatory documents should not take the place of job descriptions and operational training; they are there to create regulatory compliance.  We often find that many of the tasks laid out in SOPs are there to help people do their job; they do not address regulatory need.  

This means that any situation that is not completely aligned with the way things were operationally when the SOP was written, now run the risk of causing unnecessary compliance failure.


  7. Manage all regulated documents in the same repository. Having multiple systems or, worse, no system at all, makes it difficult to view the entire portfolio.  If documents are in different locations then employees run the risk of not knowing where to look for the definitive version of documents. 

It becomes difficult to quickly assess the impact of a change and there is a significant risk of personally held (and therefore uncontrolled) versions being used to execute critical processes.


  8. Ensure vital training is proportionate to the level of involvement.  If a role is central to the execution of a process then organizations need to make sure that the right people have received training.  If, however, a role is involved only occasionally in the process, or influences only a small section of it, then the training for that role needs to be appropriate for the level of involvement.  

This requires on-demand training and training courses that target sub-components of the process.  Training everyone on everything is neither popular nor effective.


  10. Make sure that creating and deploying new documentation and processes is not a “once and done” activity.  Organizations must enable the business to support continuous improvement and monitoring of the document portfolio.  

They must also establish robust governance processes and infrastructure to provide effective oversight of the portfolio and enable rigorous monitoring to identify areas of weakness and opportunities in the portfolio.

 

 “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.


Comments

Post a Comment

Popular posts from this blog

GxP Assessment & Categorization of Computerized System

Image
Data Integrity App 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 prac...
Read more

Data Integrity Thread

Image
Data Integrity App Data integrity can be compromised through human error or, worse yet, through malicious acts. Data that’s accidentally altered during the transfer from one device to another, for example, can be compromised, or even destroyed by hackers. Common threats that can alter the state of data integrity include: Human error Unintended transfer errors Misconfigurations and security errors Malware, insider threats, and cyber attacks Compromised hardware So how do you know when your data has integrity? You have to look at the following features: Retrieve ability and accessibility – It’s important to have accurate data in the proper locations at the right time when anyone is working on projections, a deal, or presentation. Without proper and easy access and retrieval, it can be detrimental to the business, yielding the way for your competition to win. Traceability – Today, you can trace every touchpoint you make with a prospect or cu...
Read more

Minimize Data Integrity issue

Image
Data Integrity App   What is data integrity? It is important to understand what data integrity really means in order to be compliant. Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle.   Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state.   Maintaining or keeping data consistent  throughout its lifecycle  is a matter of protecting it (security) so that it’s reliable. And data that’s reliable is simply able to meet certain standards, with which compliance is necessary.   For example, the FDA uses the acronym ALCOA to define data integrity standards and to relate to good manufacturing practices. Data is expected to be: 1.          Attributable – Data should clearly demonstrate who observed and recorded it, when ...
Read more