Documented System to Handle Review Approval and Distribution of Documents

Document controls are a fundamental requirement of every medical device regulatory regime. They are the 'building blocks' of an effective Quality Management System.

What is document control in medical device development?

'Document controls' are the policies and procedures you have in place to manage the way documents are created, approved, issued, shared, updated, and archived throughout your medical device product lifecycle. They stop documents existence added or changed in a development process without dominance. They make the history of your evolution process trackable through effective version control. They ensure the right version of quality documents tin be accessed past the correct people whenever and wherever required, to assist auditing, conclusion making and investigation.

How to build your med dev eQMS: Download our free eBook

What does med dev regulation say nearly document control?

Certificate command is a major feature of medical device standards and regulation including the ISO 13485 standard and FDA 21 CFR Function 820 and  FDA 21 CFR office 11:

What are the document control requirements specified in ISO 13485?

ISO 13485 says you should develop document control process and procedures to:

• Review and corroborate documents for adequacy prior to issue;
• Review, update every bit necessary and re-approve documents;
• Ensure that the current revision status of and changes to documents are identified;
• Ensure that relevant versions of applicable documents are available at points of utilize;
• Ensure that documents remain legible and readily identifiable;
• Ensure that documents of external origin, determined by the organization to be necessary for the planning and functioning of the quality management system, are identified and their distribution controlled;
• Preclude deterioration or loss of documents;
• Foreclose the unintended use of obsolete documents and apply suitable identification to them.

What are the certificate control requirements specified in FDA 21 CFR Office 820

The FDA specify document control in their regulation also. 820.40a outlines QMS requirements for:

• Document approving and distribution.
• Each manufacturer shall designate an individual(s) to review for adequacy and corroborate prior to issuance all documents established to meet the requirements of this role.
• The approval, including the appointment and signature of the individual(due south) are approval the document, shall be documented.
• Documents established to encounter the requirements of this office shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

While 820b concentrates on requirements for document change control

• Changes to documents shall be reviewed and approved past an individual(s) in the same function or arrangement that performed the original review and approving, unless specifically designated otherwise.
• Canonical changes shall exist communicated to the appropriate personnel in a timely manner.
• Each manufacturer shall maintain records of changes to documents.
• Change records shall include a description of the alter, identification of the affected documents, the signature of the approval private(s), the blessing date, and when the change becomes effective.

Requirements for certificate command in 21 CFR Function eleven

21 CFR Part 11 outlines requirements for document control within a electronic Quality direction system, The regulation states 'companies using electronic records shall "secure, estimator-generated, time-stamped inspect trails to independently tape the data and fourth dimension of operator entries, and actions that create, modify, or delete electronic records."

It likewise, famously, specifies the demand for controlling the approval process of documents using electronic signatures.

What is 21 CFR Part xi? FDA requirements explained

What documents demand to exist 'controlled' in the med dev procedure

Some of the required documents and processes that demand to be 'controlled' in the med dev process include:

• Quality manuals
• Standard operating procedures (SOPs)
• Design input and output documents
• Test plans
• Validation checklists
• CAPA reports

How do certificate controls support quality outcomes

Controls assign ownership of cardinal documents to named individuals in your system so they cannot exist lost or orphaned. They ensure processes are properly defined and communicated to your workers, that critical events are documented properly and that records about them can be easily accessed for reference, investigation or future audit.

How document controls help you deliver on primal quality requirements

SOPs

These are the documents that prove your team 'how you practise things' and are critical to the replication of good do and consequent quality in your end products. Expert documentation controls ensure;

• They're e'er accessible and visible to the teams who need to use them
• The virtually uptodate, approved version of the SOPs are always visible
• They are properly indexed for ease of search and retrieval
• They cannot exist changed without authority
• Records of changes are kept with a total version history bachelor for auditors

Alter control

When requests are made to change the style you work, to meet new business concern or regulatory objectives, certificate controls need to kick in to ensure they are managed effectively. The document controls you have in place should ensure that proposed changes are seen by the right people, accepted, documented and results reviewed once they have been implemented. This volition ensure that changes to processes and procedures accept non led to whatever errors or nonconformities.

Across your change control process the mandated use of electronic signatures intended to provide incontrovertible proof of

• the identity of the person approving it
• the date and time a measure out was approved
• the 'intention' or significant of their approval

Design controls

Your ability to control documentation in the way defined by the regulation will help you encounter the blueprint control requirements of the medical device evolution procedure.

Both ISO and FDA require you to develop a structured stage gated pattern process that makes your process trackable and your people accountable for the decisions that are fabricated along the way.

Why design control matters in medical device development

The regulation requires you to certificate user requirements and design specifications. It requires yous verify these designs against specifications, and validate finish products against user requirements. These tasks should be carried out in a series of iterative, projection stages.

Proper document controls assistance you demonstrate that:

• You planned your procedure prior to commencing the build
• You take gathered and documented user requirements in line with the plans
• You take documented your proposed designs
• Documents have been reviewed and approved by the correct people at every stage
• Changes to requirements and designs take been approved and documented
• The right people have validated the product according to your designs

Document controls ensure that all relevant stakeholders have seen and 'signed off' on key documents before each new phase of design and development took place. And that yous can prove when and how this happened.

Stage gating tools in an eQMS can deliver the ultimate control over documentation, ensuring that 'input' and 'output' documents are grouped together and shared with specific stakeholders in automated sequences of review and publication.

Proper document controls aid you meet design requirements, mitigating the hazard of deviating from your plans, not meeting requirements and consequent damage to end users. They will ensure you accept a full and detailed tape of the process you have undertaken.

Technical files: DHF, DMR and DHR

Your ability to control documentation can likewise bear upon the way you tin get together and share the required technical information with auditors.

The FDA specifies that you should make your 'Design History Files', 'Design Master Record' and 'Device History Tape' bachelor to auditors. ISO 13485 has similar technical file requirements. These requirements are there then regulators tin verify you have developed your device in line with the standard.

DHF, DMR and DHR: Demystifying FDA medical device evolution requirements

If y'all have been controlling your documentation in line with the regulation and have the right digital tools available to you for search and retrieval - then the documents which tell the story of the evolution of your blueprint and build process will be easier to isolate and publish in a structured way.

CAPAs

Document control procedures are vital for constructive Corrective and Preventive Action processes, besides. Having the right certificate command procedures in identify will ensure that complaints are captured and recorded in your QMS, shared with and investigated by the correct people.

Using digital signatures volition permit you to show who has investigated, signed off and approved corrective and preventive actions to thee regulator. The right procedure will also ensure that these documents are reviewed in the future to check the success of the CAPAs that have been implemented.

In medical device evolution everything rests on your ability to control your documentation finer. Controls are central to delivering the quality outcomes that the regulation requires. They ensure your process is;

• Consistent
• Reliable
• Repeatable
• Trackable

And by extension, that you are managing:

• Accountability of your people throughout the process
• Traceability of the root causes of nonconformities in finish products
• The efficacy and safe of your product
• The risk of impairment to the people who will use them

The challenge for medical device developers is finding the digital tools that tin can requite you this level of control, without taking years to implement or slowing upwards the speed of your development

Tags: document management system

browncrianizied.blogspot.com

Source: https://www.cognidox.com/blog/document-control-medical-device-quality-management-system

Share this post