Doc Control is an important and critical aspect of quality and compliance. These procedures describe the processes for the creation, review, revision, issuance and distribution, retirement, archival and access of documents. Documents include SOPs, policies, manuals, batch records, forms, and templates. These controls ensure that documents are current, reviewed, and formally approved.
Establishing a clear and thorough document control system helps mitigate compliance risks. Ideally, a Doc Control System should be implemented early as part of the QMS and Drug Development Lifecycle. Implementing a Doc Control system ensures that there is documented evidence that methods and controls used in the manufacture, processing, packing, holding, and distribution of drug products meet requirements to ensure such products are safe and effective. All records are organized and maintained to aid in the retention and efficient retrieval of data and documents, especially in audits and inspections.
Our Approach
RegDev ensures that clients have the necessary documentation to meet standards. RegDev’s SOP templates are reviewed on a regular basis to ensure clients are provided with up-to-date procedures and guidelines. RegDev offers Doc Control services for clients without a Doc Control system and can help assist them with creating or refining their own system.
QUALITY MANAGEMENT SYSTEMS
MITIGATES SECURITY RISKS
GXP COMPLIANCE
DOCUMENTED PROCESS
DEFINED PROCEDURES
EXCEPTIONAL ORGANIZATION
EFFICIENCY, CONSISTENCY, AND QUALITY
Doc Control follows a documented process and procedures are defined clearly so that employees follow the standardized process for consistency and efficiency. Documents go through a proper process prior to issuance. Procedures and documents are current, reviewed, and approved by knowledgeable and experienced personnel.
SECURITY PROTOCOLS
Documents are available to those who need them but are held or stored in secure locations and managed accordingly. Doc Control prevents any unauthorized changes or access. Any obsolete or out-of-date documents are removed to ensure that they are not used.
COMPLIANCE ASSURANCE
It is a requirement that establishments maintain specific procedures to control documents. A Doc Control system ensures compliance with all the applicable laws and regulations. All personnel are trained on the up-to-date documents and to the same high standards.
Team Member Insight
“RegDev has a team of SME’s ready to customize and work one on one with clients. A whole RegDev support team can be curated to fit the Client’s requests and specifically adjust documents to fit clients needs. ”
