SOP Management

Standard operating procedures (SOPs) are vital to all quality-related, GxP compliant companies. Industries regulated by the FDA, such as pharmaceutical, medical device, and biotechnology, SOPs must be managed with strict change control processes to certify compliance with current GxP quality guidelines and regulations.

SOPs must be well structured, current, reviewed and approved in a defined workflow. They must also be changed with traceability and documentation. Training of changing work practices, and introduction training for employees not yet trained, is a vital part of SOP management.

Platina QMS for SOP management and training

SOP management and SOP training is a part of the fully-integrated Platina QMS solution, offering complete control of existing SOPs, as well as new and ongoing SOP training programmes.

Our solution is designed to streamline the handling of SOP through its entire lifecycle. This is implemented through control, ease creation, storage, retrieval, signing and distribution of SOPs in an electronic format.

SOP management control

Platina QMS SOP management integrates documents and SOP management into the processes of a company. The solution incorporates features for version and revision control, indexing, publishing, distribution and screening.

Indexing of SOPs including metadata means that the solution has powerful search tools.

SOP management training

Each training process has predefined steps and conditions for implementation and potential trainers. Training materials are stored and made available to participants. Results and certificates are recorded on users’ profiles or other relevant places in the system.

Platina QMS SOP management solution help GxP-regulated companies manage complex standard operating procedures.

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