I would appreciate it if people could share theirs, or provide the major touch points, so I can benchmark.
Thanks in advance!
I'm looking for policy statements from GxP facilities on the use of images and videos, specifically if folks differentiate:
1. Internal use
2. Client audits
3. Regulatory Inspectors
Especially curious if anyone has updated this for new live remote telepresence technologies.
Below is verbiage I often use when creating 3rd party or regulatory inspection SOPs for my clients:
Cameras, Video, and Other Recordings
Auditors and regulatory health inspectors are not allowed to bring photography or recording equipment on the COMPANY facility without express written permission from COMPANY Management unless they have the unambiguous legal authority to do so (such as the US FDA). Cell phones with photographic or recording capabilities will not be allowed out of the conference room and will not be allowed to take photographs or record video or sound.
In the case where a photograph or recording is requested by an auditor or inspector, the Inspection Lead or designee should offer to take the photo or recording with COMPANY equipment.
If the inspector agrees, the photo or recording should be taken by COMPANY personnel using placards within the view of the photograph or video where feasible to indicate the confidentiality of the photographed or recorded subject and that the photo or recording is not to be copied. A copy should be made for the inspector as well as for the inspection file.
If the inspector insists on taking the photo or recording using his/her own equipment, inform the inspector that the COMPANY would like to take a duplicate photograph or recording and use placards within the view of the photograph where feasible to indicate the confidentiality of the photographed subject and that the recording is not to be copied.
I've also attached a visitor handout that one of the mfg sites I worked at created to give to visitors. While they don't expressly deal with remote telepresence/web conferencing technologies explicitly, they are written in a way that they could also apply to those scenarios. Of course, you could add those specifics for your organization.
Note - I have seen some companies get more specific about requiring a legal review/notification in audit/inspection situations but that is really company dependant.
Hope that helps!
COMPANY typically does not allow the taking of photographs onsite by outside third parties including inspectors, auditors and/or investigators. In the event that the Investigator requests to take photographs, the Legal department must be notified and prior approval is needed prior to proceeding. COMPANY does not typically allow video recording of its premises or personnel by outside third parties. If the health authority insists on taking photographs, permission from Legal and/or Senior Management is required and arrangements should be made so that COMPANY takes photographs of the same situations immediately after the FDA. QA will be responsible for taking any photos.
COMPANY does not typically allow Investigators to record conversations. If the Investigator requests to record conversations, notify the Legal department immediately.
- PURPOSE AND OBJECTIVES
This Policy applies to:
- Digital media created in relation to GxP regulated activities
- Digital media created worldwide for local or global use
- Use of video in the facility, including security cameras
- Digital media used:
- Shared internally or with a supplier, client or regulatory agency.
- As standalone material (e.g. Virtual Reality material)
- Within a quality document to replace or supplement the text (e.g., video SOP)
- Within a training material (e.g., photos, videos, virtual visits, tool tutorials).
This policy does not apply to communication supports such as webinars, webcasts or any other video media used for communication purposes and does not view or record GxP operations or areas.
|Digital Media||Digital media is any media which depends on electronic devices for its creation, distribution, view, and storage. Examples of digital media include videos, audio and remote assist.|
|Live distribution||Digital media shared real time|
4.1 Mixed Reality headsets (e.g. hololens)
Use of headsets can reduce wearers ability to see the world around them. Wearers cannot work alone and must have an assigned buddy to watch over them.
Virtual reality can confuse the eye-brain connection. This may result in motion sickness.
Extended use of virtual reality can cause eye strain. Users should take a 10-15 minute break every 30 minutes.
Use of virtual reality may be hazardous to individuals with pre-existing medical conditions such as vision abnormalities, psychiatric disorders, heath conditions, epilepsy, seizures, and blackouts.
Involuntary muscles twitches and loss of balance may signal a potential problem with a user.
Employees who are suffering from a cold, headache, upset stomach, or other sickness should avoid use.
Virtual reality is not a media experience in that the brain experiences it as an actual experience.
- General use of Digital Media
- Employees are notified that digital media is being obtained, including if the digital media is for live distribution.
- Recording, other than security cameras, (not live distribution, for example telepresence or remote view) requires all employee and individuals to give consent before hand.
- Digital media is obtained using company equipment and presents good picture quality without pixilation, artifacts, or blurs (see Attachment 1).
- All applicable GxP requirements remain effective during the process not only for the activity but also by any individuals involved in creating the digital media (e.g. gowning).
- Live Distribution digital media is for observation purposes and is not for GMP decision making.
- Use by Clients, including Person-in-Plant visits and quality audits, of Digital Media
- Clients are not allowed to bring photography or recording equipment on the facility without express written permission from Management. Cell phones with photographic or recording capabilities are not allowed in any production area (e.g. labs, manufacturing, warehouse) and will not be allowed to take photographs or record video or sound.
- Digital media may be created by a employee and shared live with the client. This digital media is considered confidential and may not be recorded (including screen shots).
- If used during client audits, a member of quality assurance should be present at all times. Internal recordings of the audit are allowed for training or reference purposes, but not to be shared outside of <COMPANY>.
- Language must exist in the Quality Agreement, or in a separate signed agreement, that the digital media is confidential and will not be recorded or rebroadcast without consent. See Attachment 2
- Use of Digital Media for External Audits, including Regulatory Inspections
- Auditors and regulatory health inspectors are not allowed to bring photography or recording equipment on the facility without express written permission from Management unless they have the unambiguous legal authority to do so.
- Cell phones with photographic or recording capabilities will not be allowed out of the conference room and will not be allowed to take photographs or record video or sound without express written permission from Management.
- In the case where a photograph or recording is requested by an auditor or inspector, the Inspection Lead or designee should offer to take the photo or recording with <company> equipment.
- If the inspector agrees, the photo or recording should be taken by <company> personnel using placards within the view of the photograph or video where feasible to indicate the confidentiality of the photographed or recorded subject and that the photo or recording is not to be copied. A copy should be made for the inspector as well as for the inspection file.
- If the inspector obtains permission from Management to take the photo or recording using his/her own equipment, inform the inspector that <company> would like to take a duplicate photograph or recording and use placards within the view of the photograph where feasible to indicate the confidentiality of the photographed subject and that the recording is not to be copied.
- Editing and storage of recorded digital media
- The “Digital Editor”:
- General use of Digital Media
- Collects all original materials created
- Selects the relevant records
- Assembles the selected records in a coherent and educational way
- Performs the editing (cuts, inserts)
- Adds any required voice over, closed captioning (CC), subtitling or text inserts as needed
- Exports the final video from the editing software
- Saves the project file for a potential future update
- Supports storage of any content used for the editing activity (e.g. pictures, text) including the project file
- Recordings not intended for GxP use may be stored on any company file repository (e.g. sharepoint)
- Digital media intended for GxP use (e.g. video SOP, training, validation, supplemental instructions) is published according to the same approval process and lifecycle in the appropriate quality system (document control, training, validation, etc).
Attachment 1: AV Encoding Parameters
|Video Stream||Recommended Setting|
|Format (for recording)||MP4|
|Bit Rate||Minimum 4Mbps|
|Frame Size||At least 720p (1280*70)|
|Frame Rate||At least 24 fps (frames per second)|
|Compression||AAC, MP3, Wave|
|Sample Size/Frequency||44, 1 kHz or lower|
|Bit rate||32 Kbps|
|Sound Levels||Normalized, around 12 db (no peaks or low sound)|
Attachment 2: Digital Technology Use and Confidentiality Agreement
<COMPANY> will be granting the undersigned live remote audio/video access to restricted and confidential areas and operations within its facility via a digital application. In addition to the terms of the Confidentiality Agreement, Manufacturing Services Agreement and Quality Agreement between the undersigned’s company and <company>, the undersigned understands and agrees to the following conditions:
- Screenshots, pictures, and/or audio/video recording of any kind that captures, stores, or replicates the live content is strictly prohibited.
- Broadcasting, publishing, or re-streaming (or forward streaming) of any live content or images is strictly prohibited.
- Viewing of content shall be done in a secure and private area whereby only the undersigned could possibly be able to view the live content provided.
- Should the undersigned leave such secure area, the undersigned agrees to exit the digital application and lock the device (ex. computer, tablet, phone) from which the undersigned has accessed the live content, and/or take any other necessary measures to prevent unauthorized access of the live content.
This Agreement and its terms and conditions are hereby acknowledged, accepted, and agreed to: