Regulatory Document Management using SharePoint – 5 reasons to procure a COTS system

I was asked to provide inputs to help in the decision-making process by a customer of ours who were trying to figure out if they should leverage native SharePoint for their Regulatory Document Management or look for a Commercial-Off-The-Shelf (COTS) package built on top of SharePoint. I have given 5 reasons from my list, below:

1.       Customization Vs Configuration

SharePoint, implemented as a Document Management System would provide the ability to store and retrieve documents along with other features like version control etc. However, in order to leverage it for regulatory document management a lot of customization is required in terms of workflow, terminology, metadata, reports etc. In contrast a COTS system comes with flexible, predefined workflow and other features required for regulatory document management system of a Life Sciences organization’s requirement.

2.       Rapid Implementation

Traditional SharePoint roll-out may take months to implement and configure it for regulatory requirements like 21 CFR Part 11, Electronic/Digital Signatures etc. On top of that, customization of SharePoint is required to adopt it for regulatory document management. A COTS system implementation is typically completed much faster including validation of the system to comply with regulatory requirements such as 21 CFR part 11.

3.     Electronic Signatures, Audit Trail and 21 CFR Part 11 compliance:

Most COTS systems are available with e-signatures that are required as part of 21 CFR Part 11 compliance. A regular SharePoint implementation demands additional effort to be spent to configure this feature such that it is applicable to regulatory document management. The COTS systems also provide audit trail feature which is then leveraged in reporting and assists in audit process.

4.       Metadata and Terminology

Meaningful metadata is the key to be able to search and retrieve documents easily. Also, the metadata needs to have fields that are domain specific rather than generic. Traditional SharePoint implementation does not define the metadata required to store regulatory documents whereas most COTS Regulated DMS’ come with predefined metadata for regulatory document management and also has provision to configure these based on organizational requirements.

5.       Reports and Audit

Most COTS systems provides reporting capability out of the box. However, these reports are not available in standard SharePoint implementation.

While Cost, Vendor Dependency etc. could be reasons why customers might want to use SharePoint out-of-the-box with some configuration, it will never be the same as a purposefully  designed and developed commercial system. As always, feedback and comments are welcome.

Advertisements

Tags: , , , , , , , , ,

About Venu Mallarapu

I am currently working as Associate Director at Cognizant Technology Services in their Life Sciences division. I have over 15 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for about 9 years. I have worked with small to large pharma customers to address various business requirements in R&D, Sales and Marketing areas. IT Service Management is one of my other passions. I blog and write about technology frequently and have also presented at various conferences and workshops on wide variety of topics in technology.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: