In this article, you will learn some tips for your contemporaneous data according to GDP Good Documentation Practices as per FDA requirements. Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your training activities fast and easily.
Definition of Contemporaneous
It means that an event occurred, or was originated during the same time in which it was documented. They represent the best recollection of what you witnessed.
Contemporaneous documentation means information, records, and other documents which exist or brought into existence at the time it was developed or implemented.
Contemporaneous data according to GDP Good Documentation Practices and Good Documentation Practices is:
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at firstname.lastname@example.org.
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM procedure templates in .pdf format.
To see the complete list of the most popular quality procedures templates, click here.
In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.
Silver Option. We Can Bring You a Formal Training on Contemporaneous Data according to GDP Good Documentation Practices.
This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools. It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant. Request a quote now.
Gold Option. We Can Create Customized Quality Procedures.
One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.
GET IN COMPLIANCE TODAY WITH CONTEMPORANEOUS DATA ACCORDING TO GDP GOOD DOCUMENTATION PRACTICES, CONTACT US (Hablamos Español)
For more information about Contemporaneous Data according to GDP Good Documentation Practices, refer to:
TITLE 21–FOOD AND DRUGS
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
QS Regulation and Guidance • Quality System Regulation and Preamble – Contemporaneous Data according to GDP Good Documentation Practices,
Inspection Guide – Pages 8, 15, 21, 22 and 23
Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]